K834332 is an FDA 510(k) clearance for the BOUNDARY SINGLE-USE GOWNS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984, 141 days after receiving the submission on December 12, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K834332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1983 |
| Decision Date | May 01, 1984 |
| Days to Decision | 141 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 |