K210148 is an FDA 510(k) clearance for the Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460). This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. (Istanbul, TR). The FDA issued a Cleared decision on April 13, 2022, 447 days after receiving the submission on January 21, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2021 |
| Decision Date | April 13, 2022 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |