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510(k) Data Aggregation
K Number
K112741Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
2012-09-13
(358 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LIFESTYLE SAFTY PRODUCTS (HUI ZHOU) CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's hand or fonger to prevent contamination between patient and examiner. It is sold as non sterile.
Device Description
Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06e1, except for sterility requirements.
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