K212309 is an FDA 510(k) clearance for the Non-sterile, Powder-Free Latex Examination Glove. This device is classified as a Latex Patient Examination Glove (Class I - General Controls, product code LYY).
Submitted by Sri Trang Gloves (Thailand) Public Company Limited (Hatyai, TH). The FDA issued a Cleared decision on April 8, 2022, 259 days after receiving the submission on July 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 | K212309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2021 |
| Decision Date | April 08, 2022 |
| Days to Decision | 259 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LYY - Latex Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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. |