K212633 is an FDA 510(k) clearance for the Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by String King Lacrosse, LLC (Gardena, US). The FDA issued a Cleared decision on November 24, 2021, 97 days after receiving the submission on August 19, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2021 |
| Decision Date | November 24, 2021 |
| Days to Decision | 97 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 |