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Found 4 results
510(k) Data Aggregation
K Number
K992020Device Name
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
Manufacturer
Date Cleared
1999-07-26
(40 days)
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTSWAY HOLDINGS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Not Found
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K Number
K992021Device Name
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
Manufacturer
Date Cleared
1999-07-23
(37 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTSWAY HOLDINGS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.
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K Number
K991750Device Name
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN
Manufacturer
Date Cleared
1999-06-23
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTSWAY HOLDINGS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powder Free containing 50 ugm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of the examiner to prevent contamination between patient and examiner.
Device Description
BRIGHTWAY™ Brand Blue Color Latex Examination Gloves, Powder Free containing 50 µgm or less of water extractable protein per gram.
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K Number
K991752Device Name
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
Manufacturer
Date Cleared
1999-06-23
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BRIGHTSWAY HOLDINGS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powdered containing 150 ugm or less of water extractable protein per grain is a usposable passimilar personnel to prevent contamination between patient and examiner.
Device Description
BRIGHTWAY™ Brand Blue Color Latex Examination Gloves, Powdered containing 150 μgm or less of water extractable protein per gram.
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