510(k) K120192 ยท FYA Gown, Surgical
DISPOSABLE SURGICAL GOWNS
| Applicant | Weihai Hongyu Nonwoven Fabric Products Co., Ltd., Weihai, KM |
| Decision | Substantially Equivalent, Oct 16, 2012 |
| Received | Jan 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120192
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2022 | Texas Medical Technology Inc. Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.