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Found 5 results
510(k) Data Aggregation
K Number
K994276Device Name
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)
Manufacturer
Date Cleared
2000-10-20
(305 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BIOPRO (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BioproTM, Nitrilon™, Correct Touch® (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to present contamination between patient and examiner.
Device Description
Biopro™, Nitrilon™, Correct Touch® or any other private labeling Nitrile Powdered Examination Gloves (Green, Purple)
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K Number
K994281Device Name
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)
Manufacturer
Date Cleared
2000-10-20
(305 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BIOPRO (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Biopro™, Nitrilon™, Correct Touch (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Device Description
Biopro™, Nitrilon™, Correct Touch or any other private labeling Nitrile Powder Free Examination Gloves (Green, Purple)
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K Number
K994043Device Name
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
Manufacturer
Date Cleared
2000-01-11
(43 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BIOPRO (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Biopro™, Correct Touch® (Powdered) is a medical glove which is worn on the hand of health care and similar personnel to prevent contamination between patient and the examiner.
Device Description
Latex Powdered Examination Glove
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K Number
K992358Device Name
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
Manufacturer
Date Cleared
1999-09-10
(58 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BIOPRO (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free 911 Latex Examination gloves is disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Gloves (colored) BLUE
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K Number
K981333Device Name
NITRILON CORRECT-TOUCH
Manufacturer
Date Cleared
1998-06-22
(70 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BIOPRO (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of A medical grow similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Nitrilon™ Correct-Touch® Nitrile Powder-Trade Name: Free Examination Gloves
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