K213910 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs. This device is classified as a Medical Glove, Specialty (Class I - General Controls, product code LZC).
Submitted by Changzhou Universal Medical Equipment Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on March 10, 2022, 85 days after receiving the submission on December 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Disposable Medical Glove (examination Or Surgeons) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc..
| 510(k) Number | K213910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2021 |
| Decision Date | March 10, 2022 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZC - Medical Glove, Specialty |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Disposable Medical Glove (examination Or Surgeons) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc. |