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510(k) Data Aggregation
K Number
K161961Device Name
UniTex Non-Sterile, Powder-Free, Latex Examination Glove
Manufacturer
UG GLOBAL RESOURCES SDN BHD
Date Cleared
2017-05-11
(297 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG GLOBAL RESOURCES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner.
Device Description
The subject device of this submission is a natural rubber latex examination glove. The glove is non-sterile and meets the recommendations of ASTM D3578-05(2015). The device is natural in color.
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K Number
K111604Device Name
LANO-E
Manufacturer
UG GLOBAL RESOURCES SDN BHD
Date Cleared
2012-06-08
(366 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG GLOBAL RESOURCES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim
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K Number
K111718Device Name
LANO-E
Manufacturer
UG GLOBAL RESOURCES SDN BHD
Date Cleared
2012-06-08
(354 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG GLOBAL RESOURCES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 the patient and the examiner.
Device Description
Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue
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