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510(k) Data Aggregation
K Number
K112988Device Name
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS LIMITED
Date Cleared
2011-11-09
(34 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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
Powder Free Latex Patient Exam Glove, Smooth and Textured Natural Color (Off White) with Protein Labeling Claim (50 µg/dm² or less of water soluble protein)
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