Blue Latex Examination Powder Free Gloves— 510(k) K192329

Clearance details

Applicant

Jr Engineering & Medical Technologies (M) Sdn. Bhd.

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2019-08-27

Decision date

2019-11-25

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Hulu Selangor, MY

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