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510(k) Data Aggregation
K Number
K232319Device Name
Black Pearl Nitrile Examination Glove
Manufacturer
Date Cleared
2024-04-22
(263 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG Global Resources Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Black Pearl Nitrile Examination Glove is a single use examination glove, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The nitrile glove is an ambidextrous, beaded cuff and black in colour. It meets the performance requirements in accordance with ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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K Number
K162510Device Name
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Manufacturer
Date Cleared
2017-07-18
(313 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UG GLOBAL RESOURCES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner and the patient.
Device Description
The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10. The device is Blue in color.
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