UniTex Non-Sterile, Powder-Free, Latex Examination Glove— 510(k) K161961

Substantially Equivalent

Ug Global Resources Sdn. Bhd.

FDA 510(k) clearance K161961 for UniTex Non-Sterile, Powder-Free, Latex Examination Glove, Substantially Equivalent on 2017-05-11. Applicant: Ug Global Resources Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Ug Global Resources Sdn. Bhd.
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seremban, MY
Download summary PDFView on FDA.gov ↗

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