Submission Details
| 510(k) Number | K171898 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2017 |
| Decision Date | August 18, 2017 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
Aug 2017
Decision
53d
Days
Class 1
Risk
About This 510(k) Submission
K171898 is an FDA 510(k) clearance for the Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on August 18, 2017, 53 days after receiving the submission on June 26, 2017. 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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