VINYL EXAM GLOVE POWERED— 510(k) K970144

Substantially Equivalent

Hiyi Export Co.

FDA 510(k) clearance K970144 for VINYL EXAM GLOVE POWERED, Substantially Equivalent on 1997-04-22. Applicant: Hiyi Export Co.. Device class: 1.

Clearance details

Applicant: Hiyi Export Co.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1997-01-15
Decision date: 1997-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Green Valley, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.