Search Results
Found 7 results
510(k) Data Aggregation
K Number
K011924Device Name
POWDERED BLUE NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-07-10
(20 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SELTOM PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Powdered Blue Nitrile Examination Gloves
Ask a Question
Ask a specific question about this device
K Number
K011922Device Name
POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-07-05
(15 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SELTOM PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Powdered Latex Examination Gloves Without Protein Content Labelling Claim
Ask a Question
Ask a specific question about this device
K Number
K003934Device Name
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2001-01-26
(37 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SELTOM PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K991777Device Name
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)
Manufacturer
Date Cleared
1999-08-31
(98 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SELTOM PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Device Description
LATEX Powder Free Patient Examination Gloves with A PROTEIN LABELING CLAIM 2 50 MICROGRAMS OF TOTAL EXTRACTABLE PROTETH
Ask a Question
Ask a specific question about this device
K Number
K991778Device Name
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
Manufacturer
Date Cleared
1999-08-31
(98 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SELTOM PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Device Description
Latex Examination Gloves Polymer Coated (Powder-Free)
Ask a Question
Ask a specific question about this device
K Number
K991776Device Name
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
Manufacturer
Date Cleared
1999-08-11
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SELTOM PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Device Description
Nitrile Powder Free Patient Examination Gloves, Now-Stern e Device Name
Ask a Question
Ask a specific question about this device
K Number
K991779Device Name
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
Manufacturer
Date Cleared
1999-08-11
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SELTOM PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Device Description
Nitrile Powder Free Patient Examination Gloves (BLUE), Non-sterile
Ask a Question
Ask a specific question about this device
Page 1 of 1