K221027 is an FDA 510(k) clearance for the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)). This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Allmed Medical (Hubei) Protective Products Co., Ltd. (Zhijiang, CN). The FDA issued a Cleared decision on August 12, 2022, 128 days after receiving the submission on April 6, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K221027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2022 |
| Decision Date | August 12, 2022 |
| Days to Decision | 128 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 |