K973699 is an FDA 510(k) clearance for the ULTRALON POWDER FREE LATEX SURGICAL GLOVE. This device is classified as a Surgeon's Gloves (Class I - General Controls, product code KGO).
Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on December 16, 1997, 78 days after receiving the submission on September 29, 1997.
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 | K973699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1997 |
| Decision Date | December 16, 1997 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |