K212639 is an FDA 510(k) clearance for the Disposable Medical Nitrile Examination Gloves (Non sterile). This device is classified as a Medical Glove, Specialty (Class I - General Controls, product code LZC).
Submitted by Jiangsu Nanfang Medical Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 8, 2021, 110 days after receiving the submission on August 20, 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 | K212639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2021 |
| Decision Date | December 08, 2021 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |