POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE— 510(k) K010663

Name: FDA 510(k) clearance K010663
Creator: U.S. Food and Drug Administration
Published: 2001-03-30

Substantially Equivalent

Tong Ruhn Medical Products Co., Ltd.

FDA 510(k) clearance K010663 for POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE, Substantially Equivalent on 2001-03-30. Applicant: Tong Ruhn Medical Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Tong Ruhn Medical Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2001-03-06
Decision date: 2001-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mc Henry, IL, US

Download summary PDF View on FDA.gov ↗

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