Anesthesiology
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- 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
- 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
- FLGCleaner, Ultrasonic, Medical Instrument1Product Code
- FLHWasher Of Body Waste Receptacles1Product Code
- FLICabinet, Ethylene-Oxide Gas Aerator2Product Code
- BRTRestraint, Patient, Conductive1Product Code
- BYYTube, Aspirating, Flexible, Connecting2Product Code
- BYZTrap, Sterile Specimen2Product Code
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)2Product Code
- CBDBottle, Collection, Breathing System (Calibrated)2Product Code
- FLESterilizer, Steam2Product Code
- FLFSterilizer, Ethylene-Oxide Gas2Product Code
- FMADepressor, Tongue, Non-Surgical1Product Code
- FMCPatient Examination Glove1Product Code
- FMEGown, Examination1Product Code
- FMLChair, Blood Donor1Product Code
- FMPProtector, Skin Pressure1Product Code
- FMQRestraint, Protective1Product Code
- FMRDevice, Transfer, Patient, Manual1Product Code
- FMWCover, Mattress (Medical Purposes)1Product Code
- FNPUrinal1Product Code
- FNSRing Cutter1Product Code
- FNYBasin, Emesis1Product Code
- FOABoard, Cardiopulmonary1Product Code
- FOBBedpan1Product Code
- FOXStand, Infusion1Product Code
- FPFBottle, Hot/Cold Water1Product Code
- FPOStretcher, Wheeled2Product Code
- FPPStretcher, Hand-Carried1Product Code
- FPSBoard, Bed1Product Code
- FRAPurifier, Air, Ultraviolet, Medical2Product Code
- FRGWrap, Sterilization2Product Code
- FRJChair, Geriatric1Product Code
- FRKChair, Examination And Treatment1Product Code
- FRZDevice, Patient Transfer, Powered2Product Code
- GAZTubing, Noninvasive2Product Code
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2Product Code
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- KMGPurifier, Water, Ultraviolet, Medical2Product Code
- KMHSterilizer, Dry Heat2Product Code
- KMJLubricant, Patient1Product Code
- KMNChair And Table, Medical1Product Code
- KXFApplicator, Absorbent Tipped, Non-Sterile1Product Code
- KXGApplicator, Absorbent Tipped, Sterile1Product Code
- KYRBag, Ice1Product Code
- KYSInsoles, Medical1Product Code
- KYTLight, Examination, Medical, Battery Powered1Product Code
- KYWContainer, Liquid Medication, Graduated1Product Code
- KYXDispenser, Liquid Medication1Product Code
- KYZSyringe, Irrigating (Non Dental)1Product Code
- KZADevice, Vein Location, Liquid Crystal1Product Code
- KZFDevice, Medical Examination, Ac Powered1Product Code
- KZHIntroducer, Syringe Needle2Product Code
- LBJDevice, Vein Stabilization1Product Code
- LDSDevice, Pasteurization, Hot Water2Product Code
- LRJDisinfectant, Medical Devices1Product Code
- LYYLatex Patient Examination Glove1Product Code
- LYZVinyl Patient Examination Glove1Product Code
- LZAPolymer Patient Examination Glove1Product Code
- LZBFinger Cot1Product Code
- LZCPatient Examination Glove, Specialty1Product Code
- K252313Cardinal Health Nitrile Examination Gloves Extended Cuff1Cleared 510(K)
- K243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs1Cleared 510(K)
- K221157JR Medic1Cleared 510(K)
- K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)1Cleared 510(K)
- K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs1Cleared 510(K)
- K220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K220353Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K213325Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs1Cleared 510(K)
- K213076AspenMed+1Cleared 510(K)
- K212639Disposable Medical Nitrile Examination Gloves (Non sterile)1Cleared 510(K)
- K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs1Cleared 510(K)
- K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove1Cleared 510(K)
- K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)1Cleared 510(K)
- K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate1Cleared 510(K)
- K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves1Cleared 510(K)
- K183562Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink1Cleared 510(K)
- K183149Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim1Cleared 510(K)
- K190159Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove1Cleared 510(K)
- K182383Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue1Cleared 510(K)
- K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K173766PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs1Cleared 510(K)
- K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K172642Orange Non Sterile Powder Free Nitrile Examination Gloves1Cleared 510(K)
- K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST1Cleared 510(K)
- K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM1Cleared 510(K)
- K163017Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs1Cleared 510(K)
- K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves1Cleared 510(K)
- K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs1Cleared 510(K)
- K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs1Cleared 510(K)
- K141982DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS1Cleared 510(K)
- K121811POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES1Cleared 510(K)
- K121926BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM1Cleared 510(K)
- K120336NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U1Cleared 510(K)
- K102189POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM1Cleared 510(K)
- K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG1Cleared 510(K)
- K101822NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS1Cleared 510(K)
- K101436PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)1Cleared 510(K)
- K101596KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-1Cleared 510(K)
- K093500POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE1Cleared 510(K)
- K091643POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS1Cleared 510(K)
- K083410POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM1Cleared 510(K)
- K083408POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS1Cleared 510(K)
- K083409POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL1Cleared 510(K)
- K083305POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM1Cleared 510(K)
- K081971BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES1Cleared 510(K)
- K081089KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM1Cleared 510(K)
- K072197POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR1Cleared 510(K)
- K062764POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED1Cleared 510(K)
- K042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE1Cleared 510(K)
- K033789LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING1Cleared 510(K)
- K032444NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY1Cleared 510(K)
- K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED1Cleared 510(K)
- K010211STERILE NITRILE POWDER-FREE EXAMINATION GLOVES1Cleared 510(K)
- K990677ABSOGEL CHEMOTHERAPHY GLOVES1Cleared 510(K)
- K992162SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM1Cleared 510(K)
- K982832PROGUARD, RR-1, RR-21Cleared 510(K)
- K970135NITRILE GLOVES1Cleared 510(K)
- K945577GUARDIAN II GLOVE1Cleared 510(K)
- K942313GUARDIAN GLOVE1Cleared 510(K)
- K920620FLUORO-SHIELD RADIATION REDUCTION GLOVES1Cleared 510(K)
- K905527NEEDLESTICK PROTECTIVE GLOVE1Cleared 510(K)
- K905177STAT(TM) GLOVE1Cleared 510(K)
- K903142AUKUFLEX(TM) RADIATION RESISTANT GLOVES1Cleared 510(K)
- K896759PB PLUS LEAD LATEX GLOVES1Cleared 510(K)
- K895195CHEMO-TOUCH1Cleared 510(K)
- K895781ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES1Cleared 510(K)
- K893093FLOUROSHIELD RADIATION REDUCTION GLOVE1Cleared 510(K)
- K896076L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)1Cleared 510(K)
- K891315ATTENUATING SURGICAL GLOVE1Cleared 510(K)
- K891968ESP RADIATION REDUCTION EXAMINATION GLOVES1Cleared 510(K)
- K882437L3 (LEAD LATEX LYSNIG GLOVES)1Cleared 510(K)
- MDZCleaners, Medical Devices2Product Code
- MECDisinfector, Medical Devices2Product Code
- MEDSterilant, Medical Devices2Product Code
- MKBDevice, Germicidal, Ultraviolet2Product Code
- MLRSterilizer, Chemical2Product Code
- MMSLubricant, Vaginal, Patient1Product Code
- MTVSharps Needle Destruction Device2Product Code
- NRVImplantable Radio Frequency Transponder System2Product Code
- NZDStretcher, Patient Restraint1Product Code
- NZHMedication Management System, Remote2Product Code
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies2Product Code
- OHYPill Crusher/Cutter1Product Code
- OIGPowder-Free Guayle Rubber Examination Glove1Product Code
- PEQAccessories To Examination Light1Product Code
- OPCPowder-Free Polychloroprene Patient Examination Glove1Product Code
- OPHRadiation Attenuating Medical Glove1Product Code
- OPIAntimicrobial Medical Glove1Product Code
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs1Product Code
- ORWN95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies2Product Code
- OSZAntimicrobial Keyboard2Product Code
- OUGMedical Device Data System1Product Code
- OVYLiquid Chemical Processing System2Product Code
- OYSPatient Bed With Canopy/Restraints1Product Code
- PADChest Drainage Kit2Product Code
- PECSterilizer Automated Loading System2Product Code
- PJJTwo Or More Sterilant Sterilizer2Product Code
- PWMAdmission Kit (Patient Utensil)1Product Code
- PYQRfid Chip For Dental Appliance2Product Code
- PWPBlood Borne Pathogen Response Kit1Product Code
- PWSChemotherapy Administration Kit1Product Code
- PWTChemotherapy Spill Clean-Up Kit1Product Code
- PWUClean-Up Kit1Product Code
- PWVDelivery Room Apparel Kit1Product Code
- PWZMid-Stream Collection Kit1Product Code
- PXAOral Administration Set1Product Code
- PXCPersonal Protection Kit1Product Code
- PXDPrep Kit1Product Code
- PXFSitz Bath Kit1Product Code
- PXGSpill Kit1Product Code
- PXMVomitus Clean-Up Kit1Product Code
- QDOFentanyl And Other Opioid Protection Glove1Product Code
- QTVMattress And Bed Deck Cover (Medical Purposes)1Product Code
- 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
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K200633
- 510(k) Type
- Abbreviated
- Applicant
- 0 & M Halyard, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/11/2020
- Days to Decision
- 215 days
- Submission Type
- Summary