K120192 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL GOWNS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, KM). The FDA issued a Cleared decision on October 16, 2012, 267 days after receiving the submission on January 23, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K120192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2012 |
| Decision Date | October 16, 2012 |
| Days to Decision | 267 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 |