K211422 is an FDA 510(k) clearance for the Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. (Siyang, CN). The FDA issued a Cleared decision on July 2, 2021, 56 days after receiving the submission on May 7, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2021 |
| Decision Date | July 02, 2021 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |