LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT— 510(k) K123368

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

2012-11-01

Decision date

2013-05-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bestari Jaya, MY

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