LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M— 510(k) K133953

Clearance details

Applicant

Hartalega Sdn Bhd

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2013-12-23

Decision date

2014-05-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bestari Jaya, MY

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