Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- ERYDrape, Surgical, Ent2Product Code
- EYXDrape, Pure Latex Sheet, With Self-Retaining Finger Cot2Product Code
- EYYDrape, Urological, Disposable2Product Code
- FXOSuit, Surgical1Product Code
- FXPCover, Shoe, Operating-Room1Product Code
- FXXMask, Surgical2Product Code
- FXYHood, Surgical2Product Code
- FXZHelmet, Surgical1Product Code
- FYAGown, Surgical2Product Code
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid1Cleared 510(K)
- K240790Polyisoprene Surgical gloves1Cleared 510(K)
- K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl1Cleared 510(K)
- K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)1Cleared 510(K)
- K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove1Cleared 510(K)
- K231446Single-Use Latex Sterile Surgical Gloves (SG100)1Cleared 510(K)
- K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl1Cleared 510(K)
- K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential1Cleared 510(K)
- K222993Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs1Cleared 510(K)
- K230832Powdered Free Sterile Natural Rubber Latex Surgical Gloves1Cleared 510(K)
- K230304Polyisoprene Surgical Gloves1Cleared 510(K)
- K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs1Cleared 510(K)
- K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K222350Sterile Nitrile Surgical Gloves Powder Free1Cleared 510(K)
- K222620Sterilized Latex Surgical Gloves1Cleared 510(K)
- K221424Sterile Surgical Powder Free Latex Glove1Cleared 510(K)
- K222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant1Cleared 510(K)
- K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)1Cleared 510(K)
- K221748Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves1Cleared 510(K)
- K214074Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K211953Disposable Sterilized Latex Surgical Gloves1Cleared 510(K)
- K212596Sterile Latex Surgical Gloves Powder Free1Cleared 510(K)
- K212848Sterile Latex Surgical Gloves Powder Free1Cleared 510(K)
- K210969Nulife1Cleared 510(K)
- K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)1Cleared 510(K)
- K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove1Cleared 510(K)
- K211478Sterile Latex Surgical Gloves Powder Free1Cleared 510(K)
- K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs1Cleared 510(K)
- K203538SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)1Cleared 510(K)
- K200915Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs1Cleared 510(K)
- K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs1Cleared 510(K)
- K203030POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS1Cleared 510(K)
- K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs1Cleared 510(K)
- K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein1Cleared 510(K)
- K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves1Cleared 510(K)
- K192933Polyisoprene Powder Free, Black Colour Surgical Gloves1Cleared 510(K)
- K202668Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein1Cleared 510(K)
- K202090Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim1Cleared 510(K)
- K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein1Cleared 510(K)
- K201748Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs1Cleared 510(K)
- K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K201829SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)1Cleared 510(K)
- K200897Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)1Cleared 510(K)
- K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro1Cleared 510(K)
- K193217SensiCare PI and SensiCare PI Micro Surgical Gloves1Cleared 510(K)
- K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use1Cleared 510(K)
- K191860Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential1Cleared 510(K)
- K191869Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim1Cleared 510(K)
- K192328JR.MEDIK Latex Surgeon’s Gloves Powder Free1Cleared 510(K)
- K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V1Cleared 510(K)
- K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)1Cleared 510(K)
- K190241Sterile Latex Surgical Glove, Powder Free1Cleared 510(K)
- K191898Sterile Latex Powder-Free Surgical Gloves1Cleared 510(K)
- K190632Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein1Cleared 510(K)
- K183536Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove1Cleared 510(K)
- K183389Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove1Cleared 510(K)
- K190782FlexGard Cut-Resistant Glove Liners1Cleared 510(K)
- K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove1Cleared 510(K)
- K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K181047Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K180221Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K171550Sterile Latex Surgical Gloves, Powder Free1Cleared 510(K)
- K173304Finessis Intense Polyisoprene Surgical Glove1Cleared 510(K)
- K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy1Cleared 510(K)
- K173386Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs1Cleared 510(K)
- K171375Gammex PI Breach Detect Powder Free Surgical Glove1Cleared 510(K)
- K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein1Cleared 510(K)
- K171987Finessis Zero Flexylon Powder Free Sterile White Surgical Glove1Cleared 510(K)
- K171279Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves1Cleared 510(K)
- K172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim1Cleared 510(K)
- K171276Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs1Cleared 510(K)
- K171047Sterile Polyisoprene Powder Free Surgical Gloves1Cleared 510(K)
- K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)1Cleared 510(K)
- K170515Sterile Nitrile Surgical Gloves, Powder-free1Cleared 510(K)
- K170152POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)1Cleared 510(K)
- K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves1Cleared 510(K)
- K162852Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove1Cleared 510(K)
- K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs1Cleared 510(K)
- K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)1Cleared 510(K)
- K160974Gammex Cut-Resistant Glove Liner1Cleared 510(K)
- K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE1Cleared 510(K)
- K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating1Cleared 510(K)
- K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)1Cleared 510(K)
- K152428SensiCare PI Surgical Gloves1Cleared 510(K)
- K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating1Cleared 510(K)
- K151694Gammex PI Hybrid Surgical Gloves1Cleared 510(K)
- K151228PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm1Cleared 510(K)
- K151114Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein1Cleared 510(K)
- K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color1Cleared 510(K)
- K151605Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves1Cleared 510(K)
- K151607Finessis Zero Flexylon Powder Free Sterile White Surgical Glove1Cleared 510(K)
- K150609Annuy Latex Surgeon's Gloves (Powdered and Powder Free)1Cleared 510(K)
- K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.1Cleared 510(K)
- K151392Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less1Cleared 510(K)
- K150146Biogel PI Micro Indicator Underglove1Cleared 510(K)
- K150973NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K142190Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K140477BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES1Cleared 510(K)
- K142992TULIP Natural Rubber Latex Surgeon's Glove (Powdered)1Cleared 510(K)
- K140989POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)1Cleared 510(K)
- K140355SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM1Cleared 510(K)
- K130450SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE1Cleared 510(K)
- K141719BIOGEL PL MICRO SURGICAL GLOVE1Cleared 510(K)
- K140988POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)1Cleared 510(K)
- K123126MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)1Cleared 510(K)
- K132802MOTEX POWDERED NITRILE SURGICAL GLOVES1Cleared 510(K)
- K122557MOTEX POWDER-FREE NITRILE SURGICAL GLOVES1Cleared 510(K)
- K131751FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES1Cleared 510(K)
- K121925POWDERED LATEX SURGEON'S GLOVE1Cleared 510(K)
- K130301LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)1Cleared 510(K)
- K123629FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES1Cleared 510(K)
- K123628STERILE LATEX SURGICAL GLOVE1Cleared 510(K)
- K121335G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE1Cleared 510(K)
- K121897PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K120934PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS1Cleared 510(K)
- K113707STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING1Cleared 510(K)
- K113233POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM1Cleared 510(K)
- K112654POWDERFREE POLYISOPRENE SURGICAL GLOVES1Cleared 510(K)
- K111413BIOGEL (R) INDICATOR (R) UNDERGLOVE1Cleared 510(K)
- K110698NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE1Cleared 510(K)
- K111878PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K111868STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING1Cleared 510(K)
- K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE1Cleared 510(K)
- K111139DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U1Cleared 510(K)
- K112089BIOGEL ORTHOPOR BROWN SURGICAL GLOVE1Cleared 510(K)
- K111807MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...1Cleared 510(K)
- K103714ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA1Cleared 510(K)
- K102177SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE1Cleared 510(K)
- K110272STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG1Cleared 510(K)
- K111015STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING1Cleared 510(K)
- K101163BIOGEL ORTHOPRO INDICATOR UNDERGLOVE1Cleared 510(K)
- K102500STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING1Cleared 510(K)
- K101811PROTEGRITY SMT LATEX SURGICALGLOVES1Cleared 510(K)
- K102119SUR-G GLOV AND MAXITEX1Cleared 510(K)
- K101102POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE1Cleared 510(K)
- K101103POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP11Cleared 510(K)
- K093300ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES1Cleared 510(K)
- K092304ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K090066POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE1Cleared 510(K)
- K081180SKINSENSE POLYISOPRENE UNDERGLOVE1Cleared 510(K)
- K073447SURGI GLOVES1Cleared 510(K)
- K071746DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES1Cleared 510(K)
- K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT1Cleared 510(K)
- K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT1Cleared 510(K)
- K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT1Cleared 510(K)
- K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K063757MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES1Cleared 510(K)
- K070619POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING1Cleared 510(K)
- K070647TRIFLEX SELECT1Cleared 510(K)
- K063582ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE1Cleared 510(K)
- K062797POWDERED LATEX SURGICAL GLOVE1Cleared 510(K)
- K062950POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)1Cleared 510(K)
- K062847BIOGEL ECLIPSE INDICATOR UNDERGLOVE1Cleared 510(K)
- K053406BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES1Cleared 510(K)
- K060030THE DOUBLE GLOVE1Cleared 510(K)
- K061038BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-1254901Cleared 510(K)
- K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE1Cleared 510(K)
- K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE1Cleared 510(K)
- K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE1Cleared 510(K)
- K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE1Cleared 510(K)
- K053272CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES1Cleared 510(K)
- K052772BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES1Cleared 510(K)
- K052177POWDER FREE STERILE LATEX SURGICAL GLOVES1Cleared 510(K)
- K052837SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA1Cleared 510(K)
- K051562NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR1Cleared 510(K)
- K052030SURGEON'S GLOVE, POWDER FREE1Cleared 510(K)
- K052031POWDERED LATEX SURGEON'S GLOVE1Cleared 510(K)
- K051793ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)1Cleared 510(K)
- K050899BIOGEL LATEX STERILE POWDER-FREE GLOVE1Cleared 510(K)
- K051563NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED1Cleared 510(K)
- K051094NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE1Cleared 510(K)
- K050071MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE1Cleared 510(K)
- K042534MARINA MEDICAL FINGER PROTECTORS1Cleared 510(K)
- K050533ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE1Cleared 510(K)
- K050181MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES1Cleared 510(K)
- K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE1Cleared 510(K)
- K043508DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)1Cleared 510(K)
- K042567POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E1Cleared 510(K)
- K042574ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)1Cleared 510(K)
- K041437MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE1Cleared 510(K)
- K041436SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X21Cleared 510(K)
- K031368POWDERED LATEX SURGEON'S GLOVES1Cleared 510(K)
- K033905PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING1Cleared 510(K)
- K040503ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR1Cleared 510(K)
- K033564POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM21Cleared 510(K)
- K032942PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE1Cleared 510(K)
- K032647ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA1Cleared 510(K)
- K023139ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE1Cleared 510(K)
- K032501MAXTER STERILE POWDER FREE SURGICAL GLOVES1Cleared 510(K)
- K031301ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING1Cleared 510(K)
- K032467MAXTER STERILE POWDERED LATEX SURGICAL GLOVES1Cleared 510(K)
- K031670STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING1Cleared 510(K)
- K031669STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING1Cleared 510(K)
- K032464ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (501Cleared 510(K)
- K031130YA MEI FIRST AID KIT1Cleared 510(K)
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- K030444PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES1Cleared 510(K)
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- K023515PRE-POWDERED LATEX SURGEON'S GLOVES1Cleared 510(K)
- K024130POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE1Cleared 510(K)
- K023236SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K022444POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA1Cleared 510(K)
- K022442POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)1Cleared 510(K)
- K021784PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)1Cleared 510(K)
- K021119POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM1Cleared 510(K)
- K021159POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM1Cleared 510(K)
- K021598ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE1Cleared 510(K)
- K014283LATEX SURGEONS GLOVE (POWDER FREE)1Cleared 510(K)
- K014278LATEX SURGEONS GLOVE (POWDERED)1Cleared 510(K)
- K021065PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM1Cleared 510(K)
- K020918ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE1Cleared 510(K)
- K020308REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE1Cleared 510(K)
- K014230STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)1Cleared 510(K)
- K014288DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS1Cleared 510(K)
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- K020019POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)1Cleared 510(K)
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- K012880STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K012896STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)1Cleared 510(K)
- K012819SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,91Cleared 510(K)
- K013603MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 651Cleared 510(K)
- K013604MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES1Cleared 510(K)
- K012479STERILE NITRILE SURGICAL GLOVES (POWDERED)1Cleared 510(K)
- K012067CLINCARE LATEX SURGEON'S GLOVE1Cleared 510(K)
- K011066STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)1Cleared 510(K)
- K012104SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES1Cleared 510(K)
- K011721ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES1Cleared 510(K)
- K012135POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K011446BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES1Cleared 510(K)
- K010862ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER1Cleared 510(K)
- K010438MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)1Cleared 510(K)
- K010439MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)1Cleared 510(K)
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- K003063GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION1Cleared 510(K)
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- K001049GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)1Cleared 510(K)
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- K001239ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K000179NUZONE NITRILE SURGICAL GLOVES POWDER FREE1Cleared 510(K)
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- K001047GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)1Cleared 510(K)
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- K000971PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE1Cleared 510(K)
- K993201HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES1Cleared 510(K)
- K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K993857THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR1Cleared 510(K)
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- K993562POWDER FREE LATEX STERILE SURGICAL GLOVES1Cleared 510(K)
- K993450LATEX SURGICAL GLOVES, PRE-POWDERED1Cleared 510(K)
- K993215DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE1Cleared 510(K)
- K993214DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS)1Cleared 510(K)
- K993349NIL, SURGEON'S GLOVE - POWDER FREE1Cleared 510(K)
- K992752SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.51Cleared 510(K)
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- K992679SURGEON POWDER-FREE GLOVES, LATEX, STERILE1Cleared 510(K)
- K991205ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K992171COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K991950LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)1Cleared 510(K)
- K991949LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)1Cleared 510(K)
- K992019LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)1Cleared 510(K)
- K992219POWDERED LATEX STERILE SURGICAL GLOVES1Cleared 510(K)
- K992018LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)1Cleared 510(K)
- K992020BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)1Cleared 510(K)
- K992021BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)1Cleared 510(K)
- K991992ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K991940BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)1Cleared 510(K)
- K984512NITRILON CORRECT-TOUCH1Cleared 510(K)
- K991939BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)1Cleared 510(K)
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- K990710BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K983982SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES1Cleared 510(K)
- K984337ELASTYLON POWDER-FREE SURGICAL GLOVE1Cleared 510(K)
- K982600PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)1Cleared 510(K)
- K981947STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)1Cleared 510(K)
- K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)1Cleared 510(K)
- K984559ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)1Cleared 510(K)
- K984066OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM1Cleared 510(K)
- K982957SENSIFLEX POWDERFREE SURGEON'S GLOVE1Cleared 510(K)
- K984064OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE1Cleared 510(K)
- K983962ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K983489ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)1Cleared 510(K)
- K983240NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES1Cleared 510(K)
- K981096SEMPERMED SURGEONS' GLOVES - SUPREME1Cleared 510(K)
- K982589SURGEON'S GLOVE1Cleared 510(K)
- K982613OMNI PRO LATEX SURGICAL GLOVE, POWDERED1Cleared 510(K)
- K982586POWDER FREE SURGEONS GLOVE1Cleared 510(K)
- K980929DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES1Cleared 510(K)
- K980880SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)1Cleared 510(K)
- K981392ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE1Cleared 510(K)
- K980942REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE1Cleared 510(K)
- K980516REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE1Cleared 510(K)
- K980412COLOURED POWDWR-FREE SURGICAL GLOVES1Cleared 510(K)
- K980564MEDI-GRIP (BEIGE 43)SURGICAL GLOVES1Cleared 510(K)
- K974783ENCORE MARK IV POWDER FREE SURGICAL GLOVES1Cleared 510(K)
- K971471ELASTYREN POWDER-FREE SURGICAL GLOVE1Cleared 510(K)
- K974356SURGEON'S GLOVES1Cleared 510(K)
- K970795SHANG HO1Cleared 510(K)
- K973699ULTRALON POWDER FREE LATEX SURGICAL GLOVE1Cleared 510(K)
- K973461ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE1Cleared 510(K)
- K972621PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)1Cleared 510(K)
- K972277DIGIFLEX SURGICAL GLOVES1Cleared 510(K)
- K972009PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE1Cleared 510(K)
- K970160UNIJECT SURGICAL GLOVES1Cleared 510(K)
- K971945PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE1Cleared 510(K)
- K962539GANTEX MODEL NSG-75PF1Cleared 510(K)
- K971381POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES1Cleared 510(K)
- K964440EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS)1Cleared 510(K)
- K970924REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE1Cleared 510(K)
- K964474ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K964980ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM1Cleared 510(K)
- K964962SENTURA SURGICAL GLOVES1Cleared 510(K)
- K962813DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES1Cleared 510(K)
- K963020GLOVEL GX1Cleared 510(K)
- K963218BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE1Cleared 510(K)
- K962724STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED1Cleared 510(K)
- K962837NULIFE1Cleared 510(K)
- K962986MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES1Cleared 510(K)
- K961632MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES1Cleared 510(K)
- K954325NEOLON NEOPRENE SURGICAL GLOVES1Cleared 510(K)
- K960178COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)1Cleared 510(K)
- K960416COMFIT MICROPTIC1Cleared 510(K)
- K960407COMFIT ORTHOPEDIC1Cleared 510(K)
- K955419POWDER FREE TACTYLON SURGEONS GLOVE1Cleared 510(K)
- K954002AMPRI1Cleared 510(K)
- K953358SURGEONS GLOVE POWDER FREE1Cleared 510(K)
- K954535ELASTYREN HYPOALLERGENIC SURGICAL GLOVES1Cleared 510(K)
- K954025SIME SURGICAL POWDERFREE1Cleared 510(K)
- K954462POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES1Cleared 510(K)
- K953712DERRICK SURESHIELD1Cleared 510(K)
- K953639NEUTRALON BROWN LATEX SURGICAL GLOVES1Cleared 510(K)
- K954049MICRO-TOUCH* LATEX SURGICAL GLOVES1Cleared 510(K)
- K953641MAXXUS ORTHOPAEDIC SURGICAL GLOVES1Cleared 510(K)
- K951908REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE1Cleared 510(K)
- K953015SAFESKIN SUPRA1Cleared 510(K)
- K952993SAFESKIN SUPRA1Cleared 510(K)
- K945505ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE1Cleared 510(K)
- K945948ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K951473ULTIMAX1Cleared 510(K)
- K951662COMFIT/BEADED SURGEON'S GLOVE1Cleared 510(K)
- K951661PROFEEL1Cleared 510(K)
- K950468POWDER FREE STERILE LATEX SURGEONS GLOVES1Cleared 510(K)
- K944053NATURAL RUBBER LATEX SURGEONS GLOVE1Cleared 510(K)
- K950185TACTYLON(TM) POWDER FREE SURGEONS GLOVE1Cleared 510(K)
- K945363MEDI PLUS SURGEON'S GLOVES1Cleared 510(K)
- K943254SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)1Cleared 510(K)
- K943255SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED)1Cleared 510(K)
- K945158MICRO-TOUCH LP LATEX SURGICAL GLOVES1Cleared 510(K)
- K945157MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES1Cleared 510(K)
- K943674NEUTRALON LP BROWN LATEX SURGICAL GLOVES1Cleared 510(K)
- K943566ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)1Cleared 510(K)
- K922979STERILE EXTRA PROTECION SURGEON'S GLOVES1Cleared 510(K)
- K945833ELASTYREN(R) SURGICAL GLOVES1Cleared 510(K)
- K941770DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES1Cleared 510(K)
- K940218SURESOFT SURGICAL GLOVES1Cleared 510(K)
- K940797SIME SURGICAL LATEX GLOVE1Cleared 510(K)
- K935464COMFIT1Cleared 510(K)
- K935227MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES1Cleared 510(K)
- K935869DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES1Cleared 510(K)
- K935870DEXTREN POWDER FREE HYPOALLERG GLOVES W/O COLORANTS1Cleared 510(K)
- K925861GIMBEL PUNCTURE RESISTANT SURGICAL GLOVE1Cleared 510(K)
- K930794MEDIGLOVES, MEDPAC, BOSTON, FISHERBRAND, GLOVES1Cleared 510(K)
- K933062B-D(R) CHALLENGE POWDER FREE SYNTHETIC SURG GLOVES1Cleared 510(K)
- K932665ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC1Cleared 510(K)
- K932664ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA1Cleared 510(K)
- K924071INTEGRON SURGICAL GLOVES1Cleared 510(K)
- K932061MIRACLE GLOVE UNDER THE GLOVE GLOVING CREAM1Cleared 510(K)
- K925030SURGEON'S GLOVE1Cleared 510(K)
- K923929PERRY POWDER-FREE GLOVES, STYLE 45G1Cleared 510(K)
- K922116POWDER FREE NITRILE GLOVE1Cleared 510(K)
- K923576STERILE NATURAL RUBBER LATEX SURGIONS' GLOVES1Cleared 510(K)
- K920745NUTEX GLOVES1Cleared 510(K)
- K915218ULTRALON POWDERFREE SURGICAL GLOVES1Cleared 510(K)
- K920876CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER1Cleared 510(K)
- K922515PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER)1Cleared 510(K)
- K921804DEXTRON SURGICAL GLOVES1Cleared 510(K)
- K915807EUDERMIC POWDER-FREE SURGICAL GLOVES1Cleared 510(K)
- K913893RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE1Cleared 510(K)
- K922769STERILE SURGEONS GLOVES -- MODIFICATION1Cleared 510(K)
- K921664BIO-GUARD LATEX SURGICAL GLOVES1Cleared 510(K)
- K914097SAFEMED LATEX SURGICAL GLOVES1Cleared 510(K)
- K915086HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES1Cleared 510(K)
- K914445PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 451Cleared 510(K)
- K914824HYPOALLERGENIC SURGEON'S GLOVES - STERILE1Cleared 510(K)
- K913402PERRY(R) DERMAGUARD(R) PLUS GLOVES1Cleared 510(K)
- K913215SURGIFIT STERILE SURGICAL GLOVES1Cleared 510(K)
- K912478SEVACARE STERILE SURGEON'S GLOVES1Cleared 510(K)
- K913207TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE1Cleared 510(K)
- K912157HYPOALLERGENIC SURGICAL LATEX GLOVES1Cleared 510(K)
- K910895SURGICAL GLOVES1Cleared 510(K)
- K912797PERRY NATURAL POWDER FREE GLOVES1Cleared 510(K)
- K911134SURGICAL GLOVES1Cleared 510(K)
- K911268SURGICAL RUBBER GLOVES1Cleared 510(K)
- K910928RUBBER LATEX SURGEONS GLOVES1Cleared 510(K)
- K911245EUDERMIC SURGICAL GLOVES1Cleared 510(K)
- K905624PROBE SURGEON'S GLOVES- STERILE1Cleared 510(K)
- K910711AMPRO SURGEON'S GLOVES1Cleared 510(K)
- K910383HPI SENSI-SHIELD GLOVE KIT1Cleared 510(K)
- K902449STERILE SURGEON'S GLOVES1Cleared 510(K)
- K904244SENSIDERM1Cleared 510(K)
- K904972SURGICARE STERILE SURGICAL GLOVES1Cleared 510(K)
- K904769SENSITOUCH1Cleared 510(K)
- K905537PERRY XTENDA CUFF SURGICAL GLOVES1Cleared 510(K)
- K904662SRI JOHANI LATEX SURGEONS GLOVES1Cleared 510(K)
- K905012STERILE SURGICAL GLOVES/DOUBLE GLOVER1Cleared 510(K)
- K904361KLEARTEX LATEX SURGEONS GLOVES1Cleared 510(K)
- K905161RUBBER LATEX SURGICAL GLOVES, STERILE1Cleared 510(K)
- K904320STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX)1Cleared 510(K)
- K903987TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED1Cleared 510(K)
- K903446COMFIT SURGEON'S GLOVES1Cleared 510(K)
- K902714LATEX SURGICAL GLOVES (YUETONG ENTERPRISE CO. LTD)1Cleared 510(K)
- K903513SANOFLEX-STERILE LATEX SURGICAL GLOVES1Cleared 510(K)
- K903534SURGEON'S (SURGICAL) GLOVES1Cleared 510(K)
- K903069KLEARTEX LATEX SURGICAL GLOVES1Cleared 510(K)
- K903212LATEX SURGICAL STERILE GLOVES1Cleared 510(K)
- K902831TACTYLON TM SURGICAL GLOVE1Cleared 510(K)
- K900587SEMPERMED SURGEON'S GLOVES1Cleared 510(K)
- K900298GAMASHIELD1Cleared 510(K)
- K902380TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE1Cleared 510(K)
- K901398LATEX SURGEON GLOVES1Cleared 510(K)
- K894828HPI ORTHO SURGEONS' GLOVE1Cleared 510(K)
- K900669HYPO-ALLERGENIC SURGICAL GLOVES1Cleared 510(K)
- K894087SURGEON'S GLOVES1Cleared 510(K)
- K901359VITAL SURGICAL GLOVES1Cleared 510(K)
- K900985SURGEONS' GLOVES W/HYPOALLERGENICITY CLAIMS1Cleared 510(K)
- K900296SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES1Cleared 510(K)
- K896675STERLING STYLE 90 SURGICAL GLOVES1Cleared 510(K)
- K895230STERILE SURGEON'S GLOVES (C T R GLOVES)1Cleared 510(K)
- K895018SURGICAL GLOVES1Cleared 510(K)
- K897192TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE1Cleared 510(K)
- K896432RUBBER LATEX SURGEON'S GLOVE1Cleared 510(K)
- K895823SURGEON'S GLOVES1Cleared 510(K)
- K892899STERILE LATEX SURGICAL GLOVE1Cleared 510(K)
- K893834ACCUMED LATEX SURGICAL GLOVE1Cleared 510(K)
- K896051LONE STAR TRADING SURGICAL GLOVE1Cleared 510(K)
- K896165STERILE HYPOALLERGENIC SURGEONS' GLOVES1Cleared 510(K)
- K892922LATEX SURGICAL GLOVES1Cleared 510(K)
- K894928STERILE LATEX SURGEON'S GLOVES1Cleared 510(K)
- K896327SURGEON'S GLOVES1Cleared 510(K)
- K895669POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES1Cleared 510(K)
- K894256STERILE SURGEONS GLOVES1Cleared 510(K)
- K894010SURGICAL GLOVES1Cleared 510(K)
- K891404STERILE LATEX SURGEON'S GLOVES1Cleared 510(K)
- K892499SAFETY SURGEONS GLOVES1Cleared 510(K)
- K892495SURGEON'S GLOVES1Cleared 510(K)
- K895448RUBBER LATEX SURGICAL GLOVES, STERILE1Cleared 510(K)
- K895603S.S.T. SURGICAL THIMBLE1Cleared 510(K)
- K895027MEDPRIDE LATEX SURGEONS GLOVES1Cleared 510(K)
- K894073INAMED PRO-TEC SILICONE SURGICAL GLOVES1Cleared 510(K)
- K892108STERILE NATURAL LATEX SURGICAL GLOVES1Cleared 510(K)
- K893899STERILE LATEX SURGICAL GLOVES1Cleared 510(K)
- K892176CORRECT TOUCH SURGEONS GLOVES1Cleared 510(K)
- K891622STERILE SURGICAL NATURAL LATEX GLOVES1Cleared 510(K)
- K894354SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES1Cleared 510(K)
- K894501AMMEL STERILE SURGEON'S GLOVES1Cleared 510(K)
- K894034MODIFIED LABELING OF SURGICAL GLOVES1Cleared 510(K)
- K884495SURGICAL GLOVES1Cleared 510(K)
- K885089SURGICAL GLOVES1Cleared 510(K)
- K893340LATEX SURGICAL GLOVES1Cleared 510(K)
- K892056SURGICAL LATEX STERILE GLOVES1Cleared 510(K)
- K884882ORIENT, LATEX SURGICAL GLOVES, STERILE1Cleared 510(K)
- K892061GRAND GUARD SURGICAL GLOVES1Cleared 510(K)
- K885271BDAC OMICRON PLUS SURGICAL GLOVES1Cleared 510(K)
- K892285MODERN (STERILE SURGEON'S GLOVES)1Cleared 510(K)
- K890289DIVERSI-MED STERILE LATEX SURGEON'S GLOVES1Cleared 510(K)
- K892064LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN1Cleared 510(K)
- K891308STERILE SURGICAL GLOVES1Cleared 510(K)
- K884328CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE)1Cleared 510(K)
- K891621STERILE SURGEONS' GLOVES1Cleared 510(K)
- K890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES1Cleared 510(K)
- K884633ARISTA AND ORIENT SURGICAL GLOVES1Cleared 510(K)
- K884622SURGICAL GLOVES1Cleared 510(K)
- K890311KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE)1Cleared 510(K)
- K884425GLOVE, SURGICAL1Cleared 510(K)
- K883556LATEX SURGICAL GLOVE (NON STERILE)1Cleared 510(K)
- K882200STERILE & NON-STERILE SURGEONS GLOVES1Cleared 510(K)
- K890073MODERN LATEX STERILE SURGICAL GLOVES1Cleared 510(K)
- K884499LATEX SURGICAL GLOVES1Cleared 510(K)
- K881664LATEX SURGICAL GLOVE1Cleared 510(K)
- K882431CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES1Cleared 510(K)
- K883466STERILE SURGICAL GLOVES1Cleared 510(K)
- K882639PALMA1Cleared 510(K)
- K882715STERILE SURGICAL LATEX GLOVES1Cleared 510(K)
- K884030ERGO II, SURGICAL LATEX GLOVES1Cleared 510(K)
- K883824STERILE SURGICAL LATEX GLOVES1Cleared 510(K)
- K883736STERILE SURGEONS GLOVES1Cleared 510(K)
- K882595MEDICAL GLOVES STERILE LATEX SURGEONS DIGIFORM1Cleared 510(K)
- K882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES1Cleared 510(K)
- K883244PRISTINE XTRA, SURGEON'S GLOVE1Cleared 510(K)
- K881374SURGEONS GLOVES1Cleared 510(K)
- K882381PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI1Cleared 510(K)
- K880480DUNFORD SURGEON'S STERILE GLOVES1Cleared 510(K)
- K881821STERILE SURGICAL LATEX GLOVE1Cleared 510(K)
- K881756STERILE SURGEONS GLOVES1Cleared 510(K)
- K880446SAFESKIN STERILE SURGEONS GLOVES1Cleared 510(K)
- K881069DISPOSABLE STERILE LATEX SURGICAL GLOVES1Cleared 510(K)
- K880535PROFECT SURGEONS' GLOVES1Cleared 510(K)
- K881191REGAL LATEX SURGICAL GLOVES1Cleared 510(K)
- K880632PROTEQ SURGEON'S GLOVES1Cleared 510(K)
- K880035DAEWOO LATEX SURGICAL GLOVE1Cleared 510(K)
- K872996NATURAL-TOUCH (TM) SURGEON'S GLOVE1Cleared 510(K)
- K875349STERILE SURGICAL NATURAL LATEX GLOVES1Cleared 510(K)
- K874539HI-TOUCH (TM) BRAND SURGICAL GLOVES1Cleared 510(K)
- K874099REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE1Cleared 510(K)
- K864521ANGEL LATEX SURGICAL GLOVES1Cleared 510(K)
- K864165MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES1Cleared 510(K)
- K864064LATEX SURGICAL GLOVES1Cleared 510(K)
- K861441NEUTRALON SURGICAL GLOVES1Cleared 510(K)
- K850635ANSELL NO POWDER SURGEON'S GLOVES1Cleared 510(K)
- K842884SURGEON'S GLOVES1Cleared 510(K)
- K844236PRISTINE1Cleared 510(K)
- K843125PERRY DERMAGUARD SURGICAL GLOVES1Cleared 510(K)
- K831632MEDICAL RUBBER GLOVES-STERILE-SURGEONS1Cleared 510(K)
- K840343PDI PREPMASTER WET PACK VAGINAL-X214771Cleared 510(K)
- K833976VANISH1Cleared 510(K)
- K832448TRIFLEX SURGEON'S GLOVES1Cleared 510(K)
- K833093VANISH II1Cleared 510(K)
- K831565MICRO-THIN SURGICAL GLOVE1Cleared 510(K)
- K823086DESERET SURGEON'S GLOVE ACCESSORY1Cleared 510(K)
- K820665DERMA PRENE1Cleared 510(K)
- K812421STERILE DISPOSABLE SURGICAL GLOVES1Cleared 510(K)
- K813565RADIATION STERILIZED SURGEON'S GLOVES1Cleared 510(K)
- K813088DESERET NEOLON SURGICAL GLOVES1Cleared 510(K)
- K812735CLOTH SURGICAL GLOVES1Cleared 510(K)
- K811753SURGEON'S GLOVES1Cleared 510(K)
- K802641GAMMEX SURGICAL GLOVES1Cleared 510(K)
- K802027VIALON SURGEON'S GLOVES1Cleared 510(K)
- K800152SURGIKOS NEUTRALON BR. SURGEON'S GLOVE1Cleared 510(K)
- K791843PONCY PAK1Cleared 510(K)
- K781847LATEX, IN-HOUSE COMPOUNDED1Cleared 510(K)
- K780419SUBCLAVIAN TRAY1Cleared 510(K)
- K770704GLOVES, SURGEONS, LATEX1Cleared 510(K)
- K770056GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE1Cleared 510(K)
- K760912DRESSING CHANGE KIT1Cleared 510(K)
- K760560CATH CARE KIT1Cleared 510(K)
- K760811GLOVE, SURGEON1Cleared 510(K)
- K760248GLOVES, APARTICULATE SURGICAL1Cleared 510(K)
- K760243GLOVES, STERILE LATEX SURGEON'S1Cleared 510(K)
- KGQCream, Gloving, Surgeon'S1Product Code
- KGTDrape, Adhesive, Aerosol1Product Code
- KKXDrape, Surgical2Product Code
- LGXTable, Examination, Medical, Powered1Product Code
- LYUAccessory, Surgical Apparel1Product Code
- MACDecontamination Kit1Product Code
- MMPCover, Barrier, Protective2Product Code
- MSHRespirator, Surgical2Product Code
- NZPSealant, Microbial2Product Code
- OEANon-Surgical Isolation Gown1Product Code
- OKFBody Fluid Disposal Kit2Product Code
- OKGBody Fluid Clean Up Kit2Product Code
- OKHBody Fluids Barrier Kit2Product Code
- OKIEmergency Response Safety Kit2Product Code
- ONTN95 Respirator With Antimicrobial/Antiviral Agent2Product Code
- OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves1Product Code
- OUKSurgical Mask With Antimicrobial/Antiviral Agent2Product Code
- OVRKit, First Aid, Talking1Product Code
- OXZPediatric/Child Facemask2Product Code
- PIRMercy Tape 2d And 3d Models1Product Code
- PLYAntimicrobial Drapes2Product Code
- PQMSurgical Smoke Precipitator2Product Code
- QBWSurgical Apparel With Material Claims2Product Code
- QMXLabel Or Tag, Non-Sterile1Product Code
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection2Product Code
- QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K161008
- 510(k) Type
- Traditional
- Applicant
- HARTALEGA SDN. BHD.
- Country
- Malaysia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/28/2016
- Days to Decision
- 108 days
- Submission Type
- Statement