K222128 is an FDA 510(k) clearance for the Protective Gown AAMI Level 4. This device is classified as a Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (Class II - Special Controls, product code QPC).
Submitted by Kenpax International Limited (Hong Kong, CN). The FDA issued a Cleared decision on August 8, 2023, 386 days after receiving the submission on July 18, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040. A Non-sterile, Non-isolation Gown Intended To Be Worn By Healthcare Personnel To Provide Moderate Or High Barrier Protection In Non-sterile And Non Patient Isolation Situations. Gowns With Antimicrobial/antiviral Agents Or Claims Are Excluded..
| 510(k) Number | K222128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2022 |
| Decision Date | August 08, 2023 |
| Days to Decision | 386 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | QPC - Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
| Definition | A Non-sterile, Non-isolation Gown Intended To Be Worn By Healthcare Personnel To Provide Moderate Or High Barrier Protection In Non-sterile And Non Patient Isolation Situations. Gowns With Antimicrobial/antiviral Agents Or Claims Are Excluded. |