Submission Details
| 510(k) Number | K232444 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 14, 2023 |
| Decision Date | December 20, 2023 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
Dec 2023
Decision
128d
Days
Class 1
Risk
About This 510(k) Submission
K232444 is an FDA 510(k) clearance for the Sterile Powder Free Latex Surgical Gloves, 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. (Zanhuang County, CN). The FDA issued a Cleared decision on December 20, 2023, 128 days after receiving the submission on August 14, 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. |
Manufacturer
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