K020593 is an FDA 510(k) clearance for the CONVERTORS SMS POLYOLEFIN GOWN. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on March 18, 2002, 24 days after receiving the submission on February 22, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K020593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2002 |
| Decision Date | March 18, 2002 |
| Days to Decision | 24 days |
| Submission Type | Special |
| 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 |