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510(k) Data Aggregation
K Number
K130450Device Name
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
Manufacturer
PURNA BINA SDN BHD
Date Cleared
2014-09-30
(585 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PURNA BINA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Surgeon's 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
MODEL 1) SURGTEX Prepowdered surgical gloves. MODEL 2) SURGTEX PF Powderfree surgical gloves. With protein content labeling claim 50 ug/dm2 or less per glove of extractable protein.
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