K211667 is an FDA 510(k) clearance for the Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). This device is classified as a N-acetylprocainamide Control Materials (Class I - General Controls, product code LAZ).
Submitted by Changzhou Universal Medical Equipment Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 23, 2021, 114 days after receiving the submission on June 1, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K211667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2021 |
| Decision Date | September 23, 2021 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LAZ - N-acetylprocainamide Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |