K220943 is an FDA 510(k) clearance for the Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Eco Medi Glove Sdn. Bhd. (Taiping, MY). The FDA issued a Cleared decision on July 19, 2022, 110 days after receiving the submission on March 31, 2022.
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 | K220943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2022 |
| Decision Date | July 19, 2022 |
| Days to Decision | 110 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. |