POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)— 510(k) K122396

Name: FDA 510(k) clearance K122396
Creator: U.S. Food and Drug Administration
Published: 2013-01-31

Substantially Equivalent

Wealth on (Jiangsu) Co., Ltd.

FDA 510(k) clearance K122396 for POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED), Substantially Equivalent on 2013-01-31. Applicant: Wealth on (Jiangsu) Co., Ltd.. Device class: 1.

Clearance details

Applicant: Wealth on (Jiangsu) Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2012-08-07
Decision date: 2013-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pennington, NJ, US

Download summary PDF View on FDA.gov ↗

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