K210785 is an FDA 510(k) clearance for the Disposable Surgical Gowns. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Chongqing Litai Fashion Group Limited Company (Chongqing, CN). The FDA issued a Cleared decision on November 13, 2021, 242 days after receiving the submission on March 16, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2021 |
| Decision Date | November 13, 2021 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |