VINYL EXAMINATION GLOVES POWDER FREE— 510(k) K974777

Name: FDA 510(k) clearance K974777
Creator: U.S. Food and Drug Administration
Published: 1998-01-30

Substantially Equivalent

Sun Flower Gloves Co., Ltd.

FDA 510(k) clearance K974777 for VINYL EXAMINATION GLOVES POWDER FREE, Substantially Equivalent on 1998-01-30. Applicant: Sun Flower Gloves Co., Ltd.. Device class: 1.

Clearance details

Applicant: Sun Flower Gloves Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1997-12-22
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, 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.