Search Results
Found 28 results
510(k) Data Aggregation
K Number
K102790Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2010-11-29
(63 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K042805Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2004-12-16
(65 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.
Device Description
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83
Ask a Question
K Number
K032374Device Name
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-10-22
(82 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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. Tested for use with Chemotherapy Drugs.
Device Description
Powder-free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored
Ask a Question
K Number
K031625Device Name
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-08-01
(66 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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
Powder-free Barrier-Pro™ Co-polymer Patient Examination Clove, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Mcthacrylic Acid Co-polymer Rubber (h)Barrier-ProTM is a registered trade mark of Dow Reichhold Specialty Latex LLC
Ask a Question
K Number
K031768Device Name
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-08-01
(53 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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
Barrier-Pro™ Co-polymer Patient Examination Glove, Powdered, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Methacrylic Acid Co-polymer Rubber (b)Barrier-Pro™ is a registered trade mark of Dow Reichhold Specialty Latex LLC
Ask a Question
K Number
K031414Device Name
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-06-26
(52 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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
Powder-free Latex Patient Examination Glove, White (non-colored) or Blue Colored, with extractable protein content labelling claim (50 microgram per gram of glove or less)
Ask a Question
K Number
K031591Device Name
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-06-26
(36 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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
Powder-free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored
Ask a Question
K Number
K031021Device Name
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-06-13
(74 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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
Polymer-Coated, Powder-free, Latcx Patient Examination Glove with Protein Labelling Claim (contain 50 microgram or less of total water extractable protein per gram)
Ask a Question
K Number
K030331Device Name
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-03-21
(49 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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
On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)
Ask a Question
K Number
K030333Device Name
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
Manufacturer
PERUSAHAAN GETAH ASAS SDN BHD
Date Cleared
2003-03-21
(49 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PERUSAHAAN GETAH ASAS 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
Latex Patient Examination Glove, Powdcred Type II, Low Modulus, with extractable protein content labelling claim (200 microgram per gram of glove or less)
Ask a Question
Page 1 of 3