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510(k) Data Aggregation
K Number
K993271Device Name
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS
Manufacturer
Date Cleared
1999-12-02
(63 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUALITY LATEX CORP. SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose and similiar personnel to prevent contamination between health care personnel and the patient.
Device Description
Latex examination gloves (with a protein label claim), Peccaler of Contamp 170 mili grams on less
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