K213144 is an FDA 510(k) clearance for the Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors. This device is classified as a Vinyl Patient Examination Glove (Class I - General Controls, product code LYZ).
Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on December 22, 2021, 86 days after receiving the submission on September 27, 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 | K213144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2021 |
| Decision Date | December 22, 2021 |
| Days to Decision | 86 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. |