K223411 is an FDA 510(k) clearance for the Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL). This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Xiamen Probtain Medical Techology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on January 4, 2023, 56 days after receiving the submission on November 9, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K223411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2022 |
| Decision Date | January 04, 2023 |
| Days to Decision | 56 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 |