K230217 is an FDA 510(k) clearance for the Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs. This device is classified as a Surgeon's Gloves (Class I - General Controls, product code KGO).
Submitted by Grand Work Plastic Products Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on May 13, 2023, 107 days after receiving the submission on January 26, 2023.
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 | K230217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2023 |
| Decision Date | May 13, 2023 |
| Days to Decision | 107 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. |