Search Results
Found 11 results
510(k) Data Aggregation
K Number
K133699Device Name
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
Manufacturer
Date Cleared
2014-07-18
(227 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free Green Polychloroprene Examination Gloves, Powder-Free Blue Polychloroprene Examination Gloves, Powder-Free Brown Polychloroprene Examination Gloves
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K Number
K101630Device Name
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
Manufacturer
Date Cleared
2010-09-07
(89 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.
Device Description
Powder Free Nitrile Examination Gloves (6Mil), Tested For Use With Chemotherapy Drugs (Blue); Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
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K Number
K101293Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
Manufacturer
Date Cleared
2010-07-01
(52 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.
Device Description
Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
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K Number
K092034Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
Manufacturer
Date Cleared
2009-10-19
(105 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves, Black
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K Number
K041848Device Name
POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
Manufacturer
Date Cleared
2004-08-20
(43 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Not Found
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K Number
K040792Device Name
POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
Manufacturer
Date Cleared
2004-08-12
(136 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Polymer Coated, Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less), White Color.
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K Number
K040791Device Name
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
Manufacturer
Date Cleared
2004-06-03
(66 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Polymer Coated, Powder Free, Nitrile Examination Gloves, Blue Color
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K Number
K030112Device Name
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB
Manufacturer
Date Cleared
2003-02-27
(45 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Gloves with protein labeling claim less than of 50 microgram or less of total water extractable protein per gram of gloves. with creamy (white) and blue colors.
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K Number
K030406Device Name
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR
Manufacturer
Date Cleared
2003-02-27
(20 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves with Peppermint Flavor
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K Number
K022814Device Name
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
Manufacturer
Date Cleared
2003-02-19
(177 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SMART GLOVE INDONESIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Examination Gloves (Powdered) Blue Pur white colors
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