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510(k) Data Aggregation
K Number
K221378Device Name
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
Manufacturer
Date Cleared
2022-09-30
(141 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Tec Gloves Industry (M) Sdn.Bhd.
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 examiner
Device Description
Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).
The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface.
These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
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