Submission Details
| 510(k) Number | K230578 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 2023 |
| Decision Date | August 31, 2023 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Aug 2023
Decision
183d
Days
Class 1
Risk
About This 510(k) Submission
K230578 is an FDA 510(k) clearance for the Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on August 31, 2023, 183 days after receiving the submission on March 1, 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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