Submission Details
| 510(k) Number | K161823 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2016 |
| Decision Date | January 23, 2017 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
Jan 2017
Decision
206d
Days
Class 1
Risk
About This 510(k) Submission
K161823 is an FDA 510(k) clearance for the Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs, 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 January 23, 2017, 206 days after receiving the submission on July 1, 2016. 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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