Cleared Traditional

Sterile Polyisoprene Powder Free Surgical Gloves

K171047 · Better Care Plastic Technology Co., Ltd. · General Hospital
Jun 2017
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K171047 is an FDA 510(k) clearance for the Sterile Polyisoprene Powder Free Surgical Gloves, 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 June 22, 2017, 76 days after receiving the submission on April 7, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K171047 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2017
Decision Date June 22, 2017
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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