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510(k) Data Aggregation
K Number
K212850Device Name
ComfortPro Blue Nitrile Examination Gloves Powder Free
Manufacturer
Date Cleared
2021-12-10
(94 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Thai Rubber Industry Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.
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K Number
K212438Device Name
Comfortpro
Manufacturer
Date Cleared
2021-12-07
(125 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Thai Rubber Industry Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Comfortpro latex examination powder free gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
COMFORTPRO 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 (No color added) and are powder free.
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