K213548 is an FDA 510(k) clearance for the Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Mercator Medical (Thailand), Ltd. (Amphur Rattaphum, TH). The FDA issued a Cleared decision on February 21, 2022, 105 days after receiving the submission on November 8, 2021.
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 | K213548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2021 |
| Decision Date | February 21, 2022 |
| Days to Decision | 105 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. |