K223304 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 Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on February 8, 2023, 104 days after receiving the submission on October 27, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K223304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2022 |
| Decision Date | February 08, 2023 |
| Days to Decision | 104 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 |