K210821 is an FDA 510(k) clearance for the Medical PVC Examination Gloves. This device is classified as a Vinyl Patient Examination Glove (Class I - General Controls, product code LYZ).
Submitted by Jiangxi Hongda Medical Equipment Group , Ltd. (Nanchang, CN). The FDA issued a Cleared decision on July 9, 2021, 112 days after receiving the submission on March 19, 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 | K210821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2021 |
| Decision Date | July 09, 2021 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |