K202076 is an FDA 510(k) clearance for the Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on March 5, 2021, 221 days after receiving the submission on July 27, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants..
| 510(k) Number | K202076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2020 |
| Decision Date | March 05, 2021 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZA — Polymer Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |