K211758 is an FDA 510(k) clearance for the Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour). This device is classified as a Powder-free Polychloroprene Patient Examination Glove (Class I - General Controls, product code OPC).
Submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on August 3, 2021, 57 days after receiving the submission on June 7, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Powder Free Polychloroprene Patient Examination Glove Is A Disposable Device Made Of Polychloroprene Rubber Tthat Bears Powder To Facilitate Donning, 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 | K211758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2021 |
| Decision Date | August 03, 2021 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | OPC — Powder-free Polychloroprene Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Powder Free Polychloroprene Patient Examination Glove Is A Disposable Device Made Of Polychloroprene Rubber Tthat Bears Powder To Facilitate Donning, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |