Submission Details
| 510(k) Number | K230217 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
May 2023
Decision
107d
Days
Class 1
Risk
About This 510(k) Submission
K230217 is an FDA 510(k) clearance for the Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs, 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 review panel. Regulated under 21 CFR 878.4460.
Device Classification
| 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. |
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