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510(k) Data Aggregation
K Number
K220834Device Name
Powder Free Nitrile Examination Glove
Manufacturer
Date Cleared
2022-06-29
(99 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
DAXWELL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device, Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and include variations of different sizes from X-Small to X-large. The color of the proposed device is Blue and Indigo
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
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K Number
K151682Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Manufacturer
Date Cleared
2015-11-17
(148 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Daxwell, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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 glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
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