K203821 is an FDA 510(k) clearance for the Donagamex Blue Performance Protective Gown. 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 Dong Nai Garment Corporation (Donagamex) (Bien Hoa City, VN). The FDA issued a Cleared decision on December 17, 2021, 353 days after receiving the submission on December 29, 2020.
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 | K203821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2020 |
| Decision Date | December 17, 2021 |
| Days to Decision | 353 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |