QUALATEX POWDERED LATEX EXAMINATION GLOVES— 510(k) K992557

Substantially Equivalent

Tan Sin Lian Industries Sdn. Bhd.

FDA 510(k) clearance K992557 for QUALATEX POWDERED LATEX EXAMINATION GLOVES, Substantially Equivalent on 1999-09-14. Applicant: Tan Sin Lian Industries Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Tan Sin Lian Industries 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
Muar, Johor, MY
Download summary PDFView on FDA.gov ↗

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