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510(k) Data Aggregation
K Number
K161390Device Name
Vinyl Exam Gloves, Powder Free, Clear
Manufacturer
Date Cleared
2016-12-19
(214 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zibo Hongchin Plastic and Rubber Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description
Subject device: Vinyl Exam Gloves, Powder Free, Clear
Device Class: Class I
Regulation number: 21 CFR 880.6250
Product code: LYZ
Length: 230 mm min
Width: 94 mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner
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