K211236 is an FDA 510(k) clearance for the Disposable Vinyl Examination Gloves. This device is classified as a Vinyl Patient Examination Glove (Class I - General Controls, product code LYZ).
Submitted by Tangshan Hongyun Healthcare Products Co., Ltd. (Tangshan, CN). The FDA issued a Cleared decision on September 27, 2021, 154 days after receiving the submission on April 26, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 | K211236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2021 |
| Decision Date | September 27, 2021 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LYZ - Vinyl Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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. |