K223008 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 Jiangxi Handspro Products Solutions Co., Ltd. (Jiujiang City, CN). The FDA issued a Cleared decision on October 8, 2022, 9 days after receiving the submission on September 29, 2022.
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 | K223008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2022 |
| Decision Date | October 08, 2022 |
| Days to Decision | 9 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. |