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510(k) Data Aggregation
K Number
K213075Device Name
Goody Gloves, Wincare, TBG Gloves
Manufacturer
Date Cleared
2022-01-20
(119 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Thai Rubber Gloves Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Blue Nitrile Examination Gloves Powder Free are equivalent to the Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only.
Blue Nitrile Examination Gloves Powder Free with sizes X-Small, Medium, Large and X-Large are included in the submission.
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