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Found 6 results
510(k) Data Aggregation
K Number
K212408Device Name
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Manufacturer
Pt. Maja Agung Latexindo
Date Cleared
2022-05-18
(288 days)
Product Code
LZA, LZC, ODO, OPJ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Pt. Maja Agung Latexindo
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.
Device Description
The Powder Free Nitrile Examination Gloves, Blue Color, Tested for Use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between patient and examiner. The gloves are ambidextrous, i.e. can be worn on right hand or left hand.
The gloves are manufactured from nitrile synthetic rubber. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate per ASTM D6978-05(2019).
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K Number
K161099Device Name
Powder Free Nitrile Examination Gloves, Black
Manufacturer
PT. MAJA AGUNG LATEXINDO
Date Cleared
2017-02-23
(310 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAJA AGUNG LATEXINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powder Free Nitrile Examination Gloves, Black 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
The proposed device is a Powder Free Nitrile Examination Glove. The glove is available in one color: Black. The proposed device is non-sterile. The Powder Free Nitrile Examination Gloves, Black meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
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K Number
K081488Device Name
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Manufacturer
PT. MAJA AGUNG LATEXINDO
Date Cleared
2008-08-28
(92 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAJA AGUNG LATEXINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free 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
A powder-free 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.
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K Number
K062709Device Name
POWDER FREE LATEX EXAMINATION GLOVES, BLACK
Manufacturer
PT. MAJA AGUNG LATEXINDO
Date Cleared
2006-12-06
(86 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAJA AGUNG LATEXINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder free Latex Examination Gloves, BLACK
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K Number
K020040Device Name
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
Manufacturer
PT. MAJA AGUNG LATEXINDO
Date Cleared
2002-08-01
(206 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAJA AGUNG LATEXINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
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K Number
K013996Device Name
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
Manufacturer
PT. MAJA AGUNG LATEXINDO
Date Cleared
2002-02-26
(85 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. MAJA AGUNG LATEXINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners
A sterile latex powderfree examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Latex Powder free Sterile Examination Gloves
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