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
- K242937Dream Medi Sterile Surgical Gown (SurgicalGownUL)2Cleared 510(K)
- K242844Medline Level 4 Surgical Gown with Breathable Sleeves2Cleared 510(K)
- K241272Stryker Steri-Shield 8 Surgical Hoods and Togas2Cleared 510(K)
- K241214ProPel SG3™ Surgical Gown2Cleared 510(K)
- K233571GCI Surgical Gown2Cleared 510(K)
- K233068Disposable Surgical Gown2Cleared 510(K)
- K233183Surgical Gown (40083)2Cleared 510(K)
- K230707Skypro, Surgical Gown 60212Cleared 510(K)
- K230610Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)2Cleared 510(K)
- K231510Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)2Cleared 510(K)
- K230577Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)2Cleared 510(K)
- K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets2Cleared 510(K)
- K222999Surgical Gown2Cleared 510(K)
- K222456High Protection Surgical Gown2Cleared 510(K)
- K223401Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)2Cleared 510(K)
- K221559Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 32Cleared 510(K)
- K213844Surgical Gown2Cleared 510(K)
- K220435SEJONG Surgical Gown Soft2Cleared 510(K)
- K222403Surgical Gown2Cleared 510(K)
- K213893Comfort Gown, Safewear Gown2Cleared 510(K)
- K212812Surgical Gown2Cleared 510(K)
- K222480Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)2Cleared 510(K)
- K221139Bodygard SFS Surgical Gown Level 42Cleared 510(K)
- K211060Disposable Surgical Gown Rk-3011C2Cleared 510(K)
- K221977Disposable Surgical Gown (G4003)2Cleared 510(K)
- K220092YADU Surgical Gowns2Cleared 510(K)
- K221637Surgical Gown (Sterile); Surgical Gown (Non-sterile)2Cleared 510(K)
- K221717Disposable Surgical Gown UM-1482Cleared 510(K)
- K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown2Cleared 510(K)
- K211399Sterile Level 3 Surgical Gown2Cleared 510(K)
- K220665Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile2Cleared 510(K)
- K220333Medline Orbis LVL 3 Surgical Gown2Cleared 510(K)
- K213177Plus Medical Cover Gown2Cleared 510(K)
- K214108Medline Orbis Chemo Surgical Gown2Cleared 510(K)
- K211036Plus Medical Chemotherapy Gown2Cleared 510(K)
- K214088Disposable Surgical Gown2Cleared 510(K)
- K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown2Cleared 510(K)
- K201351Maxima Surgical Gown2Cleared 510(K)
- K213703Surgical Gown2Cleared 510(K)
- K202845Bodygard SFS Surgical Gown Level 32Cleared 510(K)
- K203548EndoArmor™ + Surgical Gown2Cleared 510(K)
- K212718Surgical gowns2Cleared 510(K)
- K212591Disposable Surgical Gown2Cleared 510(K)
- K210355Surgical Gown, Model: surgical gown-hp-32Cleared 510(K)
- K212861Surgical Gown, Reinforced Surgical Gown2Cleared 510(K)
- K212925Disposable Surgical Gown2Cleared 510(K)
- K212869Disposable Surgical Gown, Disposable Reinforced Surgical Gown2Cleared 510(K)
- K203539Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)2Cleared 510(K)
- K211765Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown2Cleared 510(K)
- K211509Surgical Gown2Cleared 510(K)
- K211809Surgical Gown2Cleared 510(K)
- K211077Surgical Gown2Cleared 510(K)
- K202532Disposable Surgical Gowns2Cleared 510(K)
- K210510Disposable Surgical Gown2Cleared 510(K)
- K210143Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)2Cleared 510(K)
- K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown2Cleared 510(K)
- K210215Surgical Gowns2Cleared 510(K)
- K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown2Cleared 510(K)
- K202447Medline Orbis Surgical Gown2Cleared 510(K)
- K202844Medical Surgical Gowns2Cleared 510(K)
- K202706Surgical Gown (Sterile), Surgical Gown (Non-sterile)2Cleared 510(K)
- K200977Modular Toga2Cleared 510(K)
- K200824Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown2Cleared 510(K)
- K192560Surgical Gown2Cleared 510(K)
- K19229050g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown2Cleared 510(K)
- K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve2Cleared 510(K)
- K200522AERO CHROME* Breathable Performance Surgical Gowns2Cleared 510(K)
- K192362Aero Blue Performance Surgical Gowns2Cleared 510(K)
- K192194TotalShield II Surgical Helmet System2Cleared 510(K)
- K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)2Cleared 510(K)
- K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)2Cleared 510(K)
- K173847Disposable Ultra Reinforced Surgical Gown2Cleared 510(K)
- K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)2Cleared 510(K)
- K172954Medline Prevention CoolZone Gown2Cleared 510(K)
- K172445RoyalGuard Surgical Gown, i600, Breathable2Cleared 510(K)
- K170762Cardinal Health Non-Reinforced Surgical Gown2Cleared 510(K)
- K162930Aero Chrome* Select Breathable Performance Surgical Gowns2Cleared 510(K)
- K163191ComfortGuard Surgical Gown, i600, Film Reinforced2Cleared 510(K)
- K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i5002Cleared 510(K)
- K150598Blockade Surgical Gown2Cleared 510(K)
- K153255Aero Chrome* Breathable Performance Surgical Gown2Cleared 510(K)
- K133075Plus Surgical Gowns (EO Sterilized), PMGB-XXX2Cleared 510(K)
- K150151SmartGownTM surgical gown2Cleared 510(K)
- K141467SURGICAL GOWN2Cleared 510(K)
- K141606SURGICAL GOWN2Cleared 510(K)
- K142166TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES2Cleared 510(K)
- K141095STRYKER STERI-SHIELD FLYTE HYBRID TOGAS2Cleared 510(K)
- K140539AERO BLUE PERFORMANCE SURGICAL GOWN2Cleared 510(K)
- K121664T4/T5 HYTREL TOGAS2Cleared 510(K)
- K132386TOTALSHIELD SURGICAL HELMET SYSTEM2Cleared 510(K)
- K112796SURGICAL GOWN (EO STERILIZED)2Cleared 510(K)
- K121998HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED2Cleared 510(K)
- K121152SURGICAL GOWN, SMS2Cleared 510(K)
- K120192DISPOSABLE SURGICAL GOWNS2Cleared 510(K)
- K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV2Cleared 510(K)
- K111535EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER2Cleared 510(K)
- K111067JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE2Cleared 510(K)
- K110724SURGICAL PROCEDURE PACKS2Cleared 510(K)
- K1014683M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE2Cleared 510(K)
- K102692SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO2Cleared 510(K)
- K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK2Cleared 510(K)
- K093835BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN2Cleared 510(K)
- K102652NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS2Cleared 510(K)
- K103406MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS2Cleared 510(K)
- K100971ATEK SURGICAL GOWNS2Cleared 510(K)
- K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL2Cleared 510(K)
- K093115KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC1002Cleared 510(K)
- K092344LAC-MAC INNERBLOC LR SURGICAL GOWNS2Cleared 510(K)
- K093169SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)2Cleared 510(K)
- K091357MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC4002Cleared 510(K)
- K090383SRI LEVEL II SURGICAL GOWN2Cleared 510(K)
- K091097PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-5012Cleared 510(K)
- K082479SKLAR SURGICAL GOWN2Cleared 510(K)
- K080707SRI PLR GOWN2Cleared 510(K)
- K080723SRI LP GOWN2Cleared 510(K)
- K080795ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN2Cleared 510(K)
- K080627PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A2Cleared 510(K)
- K073017STRYKER STRI-SHIELD FLYTE TOGAS2Cleared 510(K)
- K070431WELMED, INC. SURGICAL GOWNS2Cleared 510(K)
- K063005STRYKER T6 HOODS AND TOGAS2Cleared 510(K)
- K062479JOYKEY SURGICAL GOWNS (STERILE)2Cleared 510(K)
- K070078STRYKER T4 HYTREL TOGA2Cleared 510(K)
- K062899MICROTEK MEDICAL SURGICAL GOWN/TOGA2Cleared 510(K)
- K062969MEDLINE STERILE DISPOSABLE SURGICAL GOWNS2Cleared 510(K)
- K061491LAC-MAC INNERBLOC O.R. GOWN2Cleared 510(K)
- K061308TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N2Cleared 510(K)
- K052824KIMBERLY-CLARK PROCEDURE GOWN2Cleared 510(K)
- K060181COMPE1 1 -PLY SURGICAL GOWNS2Cleared 510(K)
- K052550IMC SURGICAL GOWNS2Cleared 510(K)
- K051426CARLO SURGICAL GOWN2Cleared 510(K)
- K041653COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS2Cleared 510(K)
- K050786BARRIER SURGICAL GOWNS2Cleared 510(K)
- K041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS2Cleared 510(K)
- K041539COMPEL SURGICAL GOWNS2Cleared 510(K)
- K043004STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 120312Cleared 510(K)
- K041541COMPEL MLR SURGICAL GOWNS2Cleared 510(K)
- K043585MEDLINE SURGICAL GOWNS2Cleared 510(K)
- K043017PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS2Cleared 510(K)
- K042111PROMEDICAL SURGICAL GOWNS2Cleared 510(K)
- K040485MAXAIR SURGICAL HELMET SYSTEM2Cleared 510(K)
- K040764STRYKER T4 HYTREL ZIPPER TOGA2Cleared 510(K)
- K032631INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)2Cleared 510(K)
- K033057DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE2Cleared 510(K)
- K031408DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)2Cleared 510(K)
- K031933MEDLINE REUSABLE SURGICAL GOWNS (100X)2Cleared 510(K)
- K030536LAC-MAC LIMITED INNERBLOC O.R. GOWN2Cleared 510(K)
- K030364DEROYAL GOWNS, STERILE, NON-STERILE2Cleared 510(K)
- K021992DHS DISPOSABLE HOOD SYSTEM2Cleared 510(K)
- K023635SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN2Cleared 510(K)
- K023266PRIMAGARD SURGICAL GOWNS2Cleared 510(K)
- K023167BREATHABLE SURGICAL GOWN2Cleared 510(K)
- K022162STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA2Cleared 510(K)
- K013846ULTRAGARD IMPERVIOUS REINFORCED GOWN2Cleared 510(K)
- K020593CONVERTORS SMS POLYOLEFIN GOWN2Cleared 510(K)
- K012186MASTER & FRANK SURGICAL GOWNS (STERILE)2Cleared 510(K)
- K012268TRIMAX2Cleared 510(K)
- K012240MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE2Cleared 510(K)
- K012984BREATHABLE IMPERVIOUS GOWNS2Cleared 510(K)
- K010799COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)2Cleared 510(K)
- K003755MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES2Cleared 510(K)
- K003194STACKHOUSE LENS HOOD, MODEL SA-700/FS2Cleared 510(K)
- K000605STACKHOUSE LENS HOOD, MODEL SA-700/F2Cleared 510(K)
- K000902KLINIDRAPE REINFORCED SURGICAL GOWNS2Cleared 510(K)
- K000901KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION2Cleared 510(K)
- K001189MODIFICATION TO CONVERTORS SURGICAL GOWNS2Cleared 510(K)
- K993170MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS2Cleared 510(K)
- K994244CONVERTORS SURGICAL GOWNS, STERILE2Cleared 510(K)
- K992445MED-GUARD SURGEON'S GOWN2Cleared 510(K)
- K992436GOWN BACK, MODEL 13-403N; 13-404N; 13-405N2Cleared 510(K)
- K994053STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE2Cleared 510(K)
- K993148STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA2Cleared 510(K)
- K992951CONVERTORS SURGICAL GOWNS2Cleared 510(K)
- K992514CONVERTORS BREATHABLE SURGICAL GOWNS2Cleared 510(K)
- K991034CONVERTORS SURGICAL GOWNS2Cleared 510(K)
- K990395BARRIER SURGICAL GOWNS2Cleared 510(K)
- K984422STERILE BACK SURGICAL GOWN WITH HAND TOWEL2Cleared 510(K)
- K982058ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN2Cleared 510(K)
- K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES2Cleared 510(K)
- K982059ROTECNO 2000 SURGICAL GOWN2Cleared 510(K)
- K982693MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS2Cleared 510(K)
- K981393MICROCOOL SURGICAL GOWN2Cleared 510(K)
- K981073MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK2Cleared 510(K)
- K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)2Cleared 510(K)
- K972832PROVISION SURGICAL HELMET SYSTEM2Cleared 510(K)
- K970893ULTRASOUND TRANSDUCER DRAPE2Cleared 510(K)
- K962666BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN2Cleared 510(K)
- K954674P1OP2B OR P1O92T2Cleared 510(K)
- K963809COOL-ZONE2Cleared 510(K)
- K961341CONVERTORS POLYOLEFIN FABRIC GOWNS2Cleared 510(K)
- K961239DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL2Cleared 510(K)
- K955586ROBISON & SMITH SURGICAL PACKS2Cleared 510(K)
- K961083OREX SURGEON'S VEST2Cleared 510(K)
- K960073EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP2Cleared 510(K)
- K953251MERTEX-PLUS O.R./SURGEONS GOWN2Cleared 510(K)
- K944393STRYKER STERI-SHIELD SURGICAL APPAREL2Cleared 510(K)
- K951623TLC SURGICAL GOWNS2Cleared 510(K)
- K951984WHITE KNIGHT SURGEON'S VEST2Cleared 510(K)
- K945371COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS2Cleared 510(K)
- K950504PERVAL SURGICAL GOWN (MARKETING NAME)2Cleared 510(K)
- K945658INTERWOVEN(TM) REUSABLE SURGICAL GOWN2Cleared 510(K)
- K944827OREX SURGEON'S GOWN2Cleared 510(K)
- K944138INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL2Cleared 510(K)
- K931562GUARDIAN SURGEON'S GOWNS2Cleared 510(K)
- K940931ASEP(TM) PLUS SURGICAL GOWN2Cleared 510(K)
- K931456SURGICAL DRAPE AND GOWN TRAY2Cleared 510(K)
- K931144STERILE SURGEON'S GOWN, MODIFICATION2Cleared 510(K)
- K934664HYDRAGOWN2Cleared 510(K)
- K940758COMPEL SURGICAL GOWNS2Cleared 510(K)
- K934608BARRIER FABRIC 450 SURGICAL GOWN2Cleared 510(K)
- K932694KAPPLER PRO/VENT PROCEDURE GOWN2Cleared 510(K)
- K940069DRESSING CHANGE KIT2Cleared 510(K)
- K935660MEDICOTEX(TRADEMARK APPLICATION PENDING)2Cleared 510(K)
- K9306813M PREVENTION FABRIC SURGICAL GOWN #78XX2Cleared 510(K)
- K924055N-PAC2Cleared 510(K)
- K926519SURGICAL GOWN2Cleared 510(K)
- K921151O.R./SURGEONS GOWN, ITEM NO. 49512Cleared 510(K)
- K921156O.R./SURGEONS GOWN, ITEM NO.49412Cleared 510(K)
- K921155O.R./SURGEONS GOWN, ITEM NO. 49622Cleared 510(K)
- K921154O.R./SURGEONS GOWN, ITEM NO. 49622Cleared 510(K)
- K921153O.R./SURGEONS GOWN, ITEM NO. 49602Cleared 510(K)
- K921152O.R./SURGEONS GOWN, ITEM NO. 49522Cleared 510(K)
- K921158O.R./SURGEONS GOWN, ITEM NO. 49502Cleared 510(K)
- K921157O.R./SURGEONS GOWN, ITEM NO. 49422Cleared 510(K)
- K932003N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)2Cleared 510(K)
- K925715RS OPTIGUARD GOWN & DRAPE MATERIAL2Cleared 510(K)
- K923815TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS2Cleared 510(K)
- K922753COMPEL XTR2Cleared 510(K)
- K921889COMPEL O AND R2Cleared 510(K)
- K922949SURGICAL GOWN2Cleared 510(K)
- K920568STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL2Cleared 510(K)
- K920405STERILE SURGEON'S GOWN2Cleared 510(K)
- K920996BARRIER SURGICAL GOWN WITH SYMETRY FABRIC2Cleared 510(K)
- K920837STERILE CONVERTOR SAFECARE GOWN AND DRAPE2Cleared 510(K)
- K915502MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES2Cleared 510(K)
- K914235ASEP SURGEONS GOWN2Cleared 510(K)
- K914839COMPEL E2Cleared 510(K)
- K914563STERILE SUGICAL GOWN PACK2Cleared 510(K)
- K912803MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL2Cleared 510(K)
- K911508MAGNA SURGEONS GOWNS2Cleared 510(K)
- K910515FREEDOM MARK III SURGICAL HELMET SYSTEM2Cleared 510(K)
- K911568GOWN, OPERATING SURGICAL2Cleared 510(K)
- K901536STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV2Cleared 510(K)
- K902348SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*2Cleared 510(K)
- K896935CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE2Cleared 510(K)
- K894599SHIRT, OPERATING, SURGICAL2Cleared 510(K)
- K894284GOWN, OPERATING, SURGICAL2Cleared 510(K)
- K892118NON-STERILE MASKS AND CAPS2Cleared 510(K)
- K891211SURGICAL GOWN #20012Cleared 510(K)
- K891058DENTAL GOWN2Cleared 510(K)
- K890474SURGICAL GOWNS2Cleared 510(K)
- K883464SURGICAL SHIRT2Cleared 510(K)
- K882470STERILE DISPOSABLE SURGICAL GOWNS2Cleared 510(K)
- K880386KIMBERLY-CLARK PROTECTIVE SLEEVE2Cleared 510(K)
- K880383KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON2Cleared 510(K)
- K880382KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN2Cleared 510(K)
- K872758THEATRE GOWNS2Cleared 510(K)
- K871906UNIMED SURGEON'S GOWNS2Cleared 510(K)
- K864311STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)2Cleared 510(K)
- K861600SPUNGUARD PLUS SURGICAL GOWN2Cleared 510(K)
- K852870BARRIER SURGICAL GOWN2Cleared 510(K)
- K851938OMNIMED SURGICAL GOWN2Cleared 510(K)
- K851559TURQUOISE2Cleared 510(K)
- K850177MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)2Cleared 510(K)
- K844703GOWNS, SURGICAL2Cleared 510(K)
- K842958BOUNDARY SINGLE-USE OR GOWN2Cleared 510(K)
- K834332BOUNDARY SINGLE-USE GOWNS2Cleared 510(K)
- K822925BOUNDARY SINGLE-USE GOWNS2Cleared 510(K)
- K821564BOUNDARY PROCESS CHANGE2Cleared 510(K)
- K820363DISPOSABLE SURGICAL GARMENTS2Cleared 510(K)
- K820116BOUNDARY2Cleared 510(K)
- K813390BONDARY SINGLE-USE OR GOWN2Cleared 510(K)
- K811958BOUNDARY REINFORCED OR GOWN2Cleared 510(K)
- K803158IRRADIATED BOUNDARY DEVICES2Cleared 510(K)
- K802885L.A.F. ISOLATION PACK2Cleared 510(K)
- K801025ODOR MASKING AGENT FOR CONTENTS OF ALL2Cleared 510(K)
- K800929WHITE KNIGHT SURGICAL PACK2Cleared 510(K)
- K800927WHITE KNIGHT DISP. STERILE BACK GOWN2Cleared 510(K)
- K800124ULTRASOFT GOWN2Cleared 510(K)
- K792622STERILIZATION PROCESS /USE GOWNS2Cleared 510(K)
- K791062BOUNDARY SPECIALTY GOWN2Cleared 510(K)
- K781682SURGICAL GOWNS & DRAPES2Cleared 510(K)
- K781099SURGICAL GOWNS AND DRAPES2Cleared 510(K)
- K772182SURGICAL GOWN, REINFORCED2Cleared 510(K)
- K760554APPAREL, BARRIER SCRUB2Cleared 510(K)
- K760903BARRIER FABRIC 450 SURGICAL GOWNS2Cleared 510(K)
- K760864BARRIER FABRIC 450 SPECIALTY GOWN2Cleared 510(K)
- K760237GOWN, BOUNDARY SINGLE USE REINFORCED2Cleared 510(K)
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- 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
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K203539
- 510(k) Type
- Traditional
- Applicant
- Unicoglobal, Inc.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/10/2021
- Days to Decision
- 372 days
- Submission Type
- Summary