K161008 is an FDA 510(k) clearance for the POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE. This device is classified as a Surgeon's Gloves (Class I - General Controls, product code KGO).
Submitted by Hartalega Sdn Bhd (Bandar Sri Damansara, MY). The FDA issued a Cleared decision on July 28, 2016, 108 days after receiving the submission on April 11, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4460. A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants..
| 510(k) Number | K161008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2016 |
| Decision Date | July 28, 2016 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KGO - Surgeon's Gloves |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4460 |
| Definition | A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |