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510(k) Data Aggregation
K Number
K210253Device Name
Best Glove-Latex Powder Free Examination Glove
Manufacturer
Date Cleared
2021-11-05
(280 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Bestsafe Glove CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free 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
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color is added) and are powder free.
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K Number
K210249Device Name
Best Glove-Nitrile Powder Free Examination Glove
Manufacturer
Date Cleared
2021-10-25
(269 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Bestsafe Glove CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Best Glove - Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
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