K121998 is an FDA 510(k) clearance for the HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Changzhou Holymed Products Co., Ltd. (Changhou, CN). The FDA issued a Cleared decision on December 20, 2012, 164 days after receiving the submission on July 9, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K121998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2012 |
| Decision Date | December 20, 2012 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |