K220133 is an FDA 510(k) clearance for the Sterilization Wraps. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on March 10, 2022, 51 days after receiving the submission on January 18, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K220133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2022 |
| Decision Date | March 10, 2022 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |