Sterile Polyisoprene Powder Free Surgical Gloves— 510(k) K171047

Clearance details

Applicant

Better Care Plastic Technology Co., Ltd.

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2017-04-07

Decision date

2017-06-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenze County, CN

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