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510(k) Data Aggregation
K Number
K132354Device Name
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE
Manufacturer
Date Cleared
2014-06-30
(336 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ADVANCED HEALTH PRODUCTS, LOT 60 **& 61
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 on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous; i.e. can be worn on right hand or left hand.
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