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Found 11 results
510(k) Data Aggregation
K Number
K003922Device Name
NITRILE EXAMINATION GLOVES (POWERED)
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2001-02-15
(57 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003985Device Name
POWDERFREE NITRILE PATIENT EXMINATION GLOVE
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2001-02-09
(45 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010078Device Name
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2001-01-29
(19 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010054Device Name
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2001-01-26
(18 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003872Device Name
GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2001-01-23
(39 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001049Device Name
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2000-05-23
(53 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001047Device Name
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2000-04-28
(28 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000090Device Name
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2000-02-10
(28 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993793Device Name
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
2000-01-12
(64 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.
Device Description
Not Found
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K Number
K990228Device Name
GUTHRIE PRIME POWDER-FREE
Manufacturer
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
Date Cleared
1999-02-19
(25 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder-free Patient Examination glove is a disposable device which is primarily Intended for modition between patient and patient and examiner's hand or finger to prevent Intended for modition between patient and examiner.
Device Description
Powder-Free Latex Examination Trade Name: Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram
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