Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves— 510(k) K160781

Clearance details

Applicant

Semperit Investments Asia Pte , Ltd.

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2016-03-22

Decision date

2017-05-02

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Singapore, SG

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