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510(k) Data Aggregation
K Number
K222531Device Name
Synthetic Polymer Glove - Polyethylene (Black)
Manufacturer
Date Cleared
2023-01-22
(153 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UR Industry SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Polyethylene Examination Gloves, is a non-sterile 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 subject device in this 510(k) Notification is Synthetic Polymer- polyethylene - Powder Free Examination Glove. The subject device is a patient examination glove made from Low Density Polyethylene material, Black Color, Powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The available sizes of the subject devices are Small, Medium, Large. X-Large & XX Large.
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