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510(k) Data Aggregation
K Number
K131826Device Name
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
Manufacturer
Date Cleared
2013-11-22
(155 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU TOPTOUCH GLOVE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a 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
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.
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