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510(k) Data Aggregation
K Number
K122396Device Name
POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
Date Cleared
2013-01-31
(177 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEALTH ON (JIANGSU) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powdered vinyl patient examination glove, clear (non-colored) 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. The powder is made from cornstarch. It is color free and is sold as non sterile.
Device Description
Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.
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K Number
K120584Device Name
POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2012-07-10
(134 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEALTH ON (JIANGSU) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free light yellow stretch vinyl 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. It has light yellow color and is sold as non sterile.
Device Description
Powder free light-yellow stretch vinyl patient examination gloves are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. They have light yellow color.
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K Number
K110219Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2011-04-19
(84 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEALTH ON (JIANGSU) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free vinyl patient examination glove, Clear (non-colored) 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. It is sold as non sterile.
Device Description
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
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