POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE— 510(k) K161008

Clearance details

Applicant

Hartalega Sdn Bhd

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2016-04-11

Decision date

2016-07-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bandar Sri Damansara, MY

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