Search Results
Found 2 results
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.
Ask a Question
Ask a specific question about this device
K Number
K213073Device Name
Goody Gloves, Wincare, TBG Gloves
Manufacturer
Date Cleared
2021-12-29
(97 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
Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that is worn on the examiner's hand 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 (No color added) and are powder free, non-sterile, ambidextrous and single use only.
Latex Examination Powder Free Gloves with sizes X-Small, Medium, Large and X-Large are included in the submission.
Ask a Question
Ask a specific question about this device
Page 1 of 1