K093169 is an FDA 510(k) clearance for the SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE). This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by A Plus International, Inc. (Chino, US). The FDA issued a Cleared decision on November 12, 2009, 36 days after receiving the submission on October 7, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K093169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2009 |
| Decision Date | November 12, 2009 |
| Days to Decision | 36 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 |