Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue— 510(k) K182383

Clearance details

Applicant

Yty Industry (Manjung) Sdn Bhd

Product code

Code LZC

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2018-08-31

Decision date

2019-03-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sitiawan, MY

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