K162175 is an FDA 510(k) clearance for the Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less. This device is classified as a Latex Patient Examination Glove (Class I - General Controls, product code LYY).
Submitted by Vietglove Corporation (Bau Bang Province, VN). The FDA issued a Cleared decision on November 21, 2016, 110 days after receiving the submission on August 3, 2016.
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 | K162175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2016 |
| Decision Date | November 21, 2016 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| 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. |