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510(k) Data Aggregation
K Number
K163168Device Name
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
Manufacturer
HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED
Date Cleared
2017-02-23
(101 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.
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