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
- 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
- K242689AAMI Level 4 Protective; Gown2Cleared 510(K)
- K233526Medline Open-back Level 3 Protective Gown2Cleared 510(K)
- K230384PolyWear® Personal Protective Level 3 Gown2Cleared 510(K)
- K222128Protective Gown AAMI Level 42Cleared 510(K)
- K212464Dukal Corporation AAMI Level 4 Open-Back Protective Gown2Cleared 510(K)
- K203821Donagamex Blue Performance Protective Gown2Cleared 510(K)
- K210405ProTEC-USA EZDoff Gown2Cleared 510(K)
- K182830Cardinal HealthTM Poly-Coated Open-Back Protective Gown2Cleared 510(K)
- K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns2Cleared 510(K)
- 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
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K212464
- 510(k) Type
- Traditional
- Applicant
- Dukal Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/30/2022
- Days to Decision
- 236 days
- Submission Type
- Summary