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510(k) Data Aggregation
K Number
K992177Device Name
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
Manufacturer
Date Cleared
1999-07-29
(31 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. BERLIAN GLOVINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Private lebel-Nirile Examination Gloves Powder Free, Patient Examination Gloves, Nitrile 80 LZA. The document also provides detailed specifications for the gloves including sizes (XS, S, M, L, XL), length, width, and thickness at the cuff, palm, and finger tip. It also lists physical properties before and after aging, including Tensile Strength and Ultimate Elongation.
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