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510(k) Data Aggregation
K Number
K100895Device Name
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
Manufacturer
Date Cleared
2011-05-27
(422 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
DIPPED PRODUCTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) 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
Patient Examination Gloves (21 CFR 880.6250)
Product Class: I
Product Code: 80 LYY (Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578-05.). The gloves are made of natural latex rubber and are worn on the examiner's hand to prevent contamination between patient and examiner.
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