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Found 8 results
510(k) Data Aggregation
K Number
K062917Device Name
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
2006-11-02
(35 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove 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
Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50 microgram per Gram of Glove or Less)
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K Number
K062778Device Name
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
2006-10-27
(39 days)
Product Code
LZA, LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove 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
Sterile Powder-Free Nitrile Patient Examination Glove, Blue Colored,
Non-sterile Powder-free Nitrile Patient Examination Glove, Blue Colored,
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K Number
K992675Device Name
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
2000-01-20
(163 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient Examination Powder glove 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
Not Found
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K Number
K992676Device Name
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
1999-12-16
(128 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient Examination Powder-Free Polymerisation glove 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
Patient Latex Examination "Powder-Free" Trade Name: Polymer Coated Gloves
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K Number
K992681Device Name
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
1999-12-16
(128 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient Examination Powder glove sterile 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.
A patient Examination Powder-Free Chlorinated glove sterile 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
Patient Latex Examination Glove Powdered & Powder-Free, Sterile
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K Number
K992678Device Name
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
1999-11-17
(99 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient Examination Powder-Free Chlorinated glove 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
Not Found
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K Number
K992679Device Name
SURGEON POWDER-FREE GLOVES, LATEX, STERILE
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
1999-10-21
(72 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Surgeon's glove is a device made of natural or synthetic rubber * intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
SURGEON'S "POWDER-FREE"STERILE LATEX GLOVES
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K Number
K973020Device Name
PATIENT EXAMINATION POWDER-FREE GLOVES
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
1998-01-06
(146 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WEAR SAFE MALAYSIA SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient Examination Powder-Free Chlorinated glove 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
Not Found
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