K160361 is an FDA 510(k) clearance for the PRIMAGARD Isolation Gown (AAMI PB70 Level 3). This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on November 4, 2016, 269 days after receiving the submission on February 9, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K160361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2016 |
| Decision Date | November 04, 2016 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |