MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)— 510(k) K123126

Name: FDA 510(k) clearance K123126
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Substantially Equivalent

Shanghai Motex Healthcare Co., Ltd.

FDA 510(k) clearance K123126 for MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532), Substantially Equivalent on 2014-06-04. Applicant: Shanghai Motex Healthcare Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shanghai Motex Healthcare Co., Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2012-10-04
Decision date: 2014-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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