K152593 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVE POWDER FREE. This device is classified as a Latex Patient Examination Glove (Class I - General Controls, product code LYY).
Submitted by Careplus (M) Sdn Bhd (Seremban, MY). The FDA issued a Cleared decision on February 25, 2016, 168 days after receiving the submission on September 10, 2015.
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 | K152593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2015 |
| Decision Date | February 25, 2016 |
| Days to Decision | 168 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. |