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510(k) Data Aggregation
K Number
K101105Device Name
POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
Manufacturer
Date Cleared
2010-11-10
(204 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BEST PUTRA GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free 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
The Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
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K Number
K101106Device Name
POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
Manufacturer
Date Cleared
2010-11-10
(204 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BEST PUTRA GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powdered 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
The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
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K Number
K101102Device Name
POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE
Manufacturer
Date Cleared
2010-07-16
(87 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BEST PUTRA GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A BPG powder-free latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Powder-Free, Latex Surgical Glove
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K Number
K101103Device Name
POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
Manufacturer
Date Cleared
2010-07-16
(87 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BEST PUTRA GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A BPG powdered latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This excludes the lubricating or dusting powder used in the glove.
Device Description
Powdered, Latex Surgical Glove
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