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510(k) Data Aggregation
K Number
K150934Device Name
Powder Free Vinyl Patient Examination Glove (Non?-Sterile)
Manufacturer
Date Cleared
2015-12-21
(259 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LPL (HUI ZHOU) GLOVE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A 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.
Device Description
Powder Free Vinyl Patient Examination Glove (Non-Sterile) is a patient examination glove available in S, M, L, XL. The glove is provided non-sterile and meets the entire requirement of ASTM standard D 5250-06.
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K Number
K111598Device Name
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
Manufacturer
Date Cleared
2011-07-20
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LPL (HUI ZHOU) GLOVE CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free vinyl patient examination glove (non-sterile) 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 (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06, except for sterility requirements.
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