K141042 is an FDA 510(k) clearance for the MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES. This device is classified as a Latex Patient Examination Glove (Class I - General Controls, product code LYY).
Submitted by Mercator Medical (Thailand), Ltd. (Littleton, US). The FDA issued a Cleared decision on March 19, 2015, 330 days after receiving the submission on April 23, 2014.
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 | K141042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2014 |
| Decision Date | March 19, 2015 |
| Days to Decision | 330 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. |