K211765 is an FDA 510(k) clearance for the Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Cardinal Health, LLC (Waukegan, US). The FDA issued a Cleared decision on November 23, 2021, 168 days after receiving the submission on June 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 168 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 |