K896935 is an FDA 510(k) clearance for the CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on February 16, 1990, 65 days after receiving the submission on December 13, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K896935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1989 |
| Decision Date | February 16, 1990 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |