Gammex PI Hybrid Surgical Gloves— 510(k) K151694

Clearance details

Applicant

Ansell Healthcare Products, LLC

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2015-06-23

Decision date

2016-03-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Iselin, NJ, US

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