K142941 is an FDA 510(k) clearance for the Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.. This device is classified as a Surgeon's Gloves (Class I - General Controls, product code KGO).
Submitted by Pt. Medisafe Technologies (Tanjung Morawa, Medan, ID). The FDA issued a Cleared decision on November 2, 2015, 389 days after receiving the submission on October 9, 2014.
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 | K142941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2014 |
| Decision Date | November 02, 2015 |
| Days to Decision | 389 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. |