Search Results
Found 2 results
510(k) Data Aggregation
K Number
K221185Device Name
TC Gloves
Date Cleared
2022-06-22
(58 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Thanh Cong Pharmaceutical and Trading Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TC Gloves Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
TC Gloves Powder Free Latex Examination Gloves is a Class I device bearing the product code LYY (21CFR 880.6250). They meet all the current specifications listed under the ASTM D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. These gloves are white in color having Finger Texture / Ambidextrous and are powder free. The product is non-sterile.
Ask a Question
Ask a specific question about this device
K Number
K221186Device Name
TC Gloves
Date Cleared
2022-06-16
(52 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Thanh Cong Pharmaceutical and Trading Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TC Gloves- Powder Free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
TC Gloves- Powder Free Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). 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 acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous, Single use and are powder free. The product is non-sterile. Sizes available - S, M, L and XL.
Ask a Question
Ask a specific question about this device
Page 1 of 1