Anesthesiology
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- ChemistryReview Panel
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- 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
- K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)2Cleared 510(K)
- K230135Copioumed Chemotherapy Isolation Gown2Cleared 510(K)
- K223467Disposable Isolation Gown2Cleared 510(K)
- K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)2Cleared 510(K)
- K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)2Cleared 510(K)
- K212717Paneffort AAMI Level 3 Isolation Gown2Cleared 510(K)
- K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown2Cleared 510(K)
- K214116AAMI4 Isolation Gown2Cleared 510(K)
- K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))2Cleared 510(K)
- K220528Surgical Isolation Cover Gown2Cleared 510(K)
- K213832AAMI3 Isolation Gown2Cleared 510(K)
- K212422Disposable Surgical Isolation Gown2Cleared 510(K)
- K210148Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)2Cleared 510(K)
- K212698Plus Medical Isolation Gown Level 32Cleared 510(K)
- K212357Surgical isolation gown2Cleared 510(K)
- K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue2Cleared 510(K)
- K211538Protect X Level 3 Isolation Gown2Cleared 510(K)
- K210785Disposable Surgical Gowns2Cleared 510(K)
- K212504Isolation Gown AAMI Level 32Cleared 510(K)
- K210131ComfortGuard Surgical Isolation Gown2Cleared 510(K)
- K203415Surgical Isolation Gown2Cleared 510(K)
- K202310Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back2Cleared 510(K)
- K190306AMD Ritmed AssureWear VersaGown2Cleared 510(K)
- K171535SURGICAL ISOLATION GOWN2Cleared 510(K)
- K160471Medline Non-Surgical Isolation Gown-2Cleared 510(K)
- K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)2Cleared 510(K)
- K160339Cardinal Health Isolation Gown2Cleared 510(K)
- K003749100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN2Cleared 510(K)
- K982369CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS2Cleared 510(K)
- K972410IMPERVIOUS ISOLATION GOWN2Cleared 510(K)
- K971917KENTRON'S ISOLATION GOWN2Cleared 510(K)
- K971702FAR-EAST BARRIER GOWNS2Cleared 510(K)
- K970814NON-STERILE ISOLATION GOWN2Cleared 510(K)
- K960999ISOLATION GOWN2Cleared 510(K)
- K954549SURGICAL APPAREL2Cleared 510(K)
- K954747NIOMED BARRIER GOWNS2Cleared 510(K)
- K952115BARRIER GOWN, KOOL-GARD BACKLESS GOWN2Cleared 510(K)
- K952114KOOL GARD SINGLES GOWN2Cleared 510(K)
- K952116COVER GOWN2Cleared 510(K)
- K942351DI ISOLATION GOWN2Cleared 510(K)
- K941845BUSE STAFF PROTECTION GOWNS AND KITS2Cleared 510(K)
- K945223OREX ISOLATION GOWN2Cleared 510(K)
- K931145NON-STERILE ISOLATION GOWN2Cleared 510(K)
- K923162TBC TRAUMA SUIT PROTECTIVE GOWN2Cleared 510(K)
- K922442ISOLATION GOWNS2Cleared 510(K)
- K930026POLY-MED DISPOSABLE PERSONAL PROTECTION KIT2Cleared 510(K)
- K925077POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS2Cleared 510(K)
- K923188DYNASTY IMPERVIOUS ISOLATION J-SUIT2Cleared 510(K)
- K920404SURGEON'S GOWN2Cleared 510(K)
- K922234DYNASTY ISOLATION GOWN2Cleared 510(K)
- K921058DISPOSABLE ISOLATION GOWN2Cleared 510(K)
- K910410SURGICAL GOWNS, EXTRA-LARGE SIZE2Cleared 510(K)
- K891677COATED ISOLATION GOWN2Cleared 510(K)
- K880484SURGICAL GARMENTS2Cleared 510(K)
- K882281GOWN, ISOLATION, SURGICAL (FYC)2Cleared 510(K)
- K874888ISOLATION GOWN2Cleared 510(K)
- K874766INTERPRO INT'L, INC. ISOLATION GOWN2Cleared 510(K)
- K874318MAXIMUM CONTROL GOWN2Cleared 510(K)
- K864479CARETEX ISOLUTION GOWNS2Cleared 510(K)
- K851823DISPOSABLE ISOLATION GOWN2Cleared 510(K)
- K844786NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR2Cleared 510(K)
- K840229CONTROL COVER GOWN2Cleared 510(K)
- K801162BARRIER PLUS SURGEON GOWNS2Cleared 510(K)
- K801069STERILE ISOLATION GOWN2Cleared 510(K)
- K780605ISOLATION GOWN2Cleared 510(K)
- K770488ISOLATION GOWN2Cleared 510(K)
- K761080ISOLATION GOWN PACK2Cleared 510(K)
- K760904CLEANING AND ISOLATION ROOM KIT2Cleared 510(K)
- 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
Isolation Gown AAMI Level 3
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K212504
- 510(k) Type
- Traditional
- Applicant
- Kenpax International Limited
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/7/2021
- Days to Decision
- 90 days
- Submission Type
- Statement