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510(k) Data Aggregation
K Number
K130667Device Name
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
Manufacturer
Date Cleared
2013-07-24
(134 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PREVENTIVE CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An Examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger, to prevent contamination between the patient and examiner.
Device Description
The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject.
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K Number
K110102Device Name
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
Manufacturer
Date Cleared
2011-05-13
(120 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PREVENTIVE CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled
Device Description
Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled
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