K183536 is an FDA 510(k) clearance for the Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove. This device is classified as a Surgeon's Gloves (Class I - General Controls, product code KGO).
Submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on August 16, 2019, 240 days after receiving the submission on December 19, 2018.
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 | K183536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2018 |
| Decision Date | August 16, 2019 |
| Days to Decision | 240 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. |