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510(k) Data Aggregation
K Number
K231973Device Name
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
Manufacturer
Ineo Tech Sdn Bhd
Date Cleared
2023-09-29
(88 days)
Product Code
KGO, OPH
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Ineo Tech Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
Device Description
The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is a disposable sterile powder-free medical device made of polyisoprene that is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove contains radiation-attenuating particles to reduce the exposure from harmful ionizing scattered or secondary radiation on the operator's hand during fluoroscopic procedures. The glove is proposed in two (2) options. The Model 2 are made with exactly the same material and composition and differ only by their thicknesses and therefore their attenuation properties.
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