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510(k) Data Aggregation
K Number
K233740Device Name
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Manufacturer
Date Cleared
2024-02-13
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
W.A. Rubbermate Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is manufactured from nitrile rubber. Inner surface of gloves undergoes a surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
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K Number
K110418Device Name
POWDER FREE NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2011-07-13
(149 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
W.A. RUBBERMATE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purpose to provide barrier against potentially infectious materials and other contaminants.
Device Description
Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 10 Standard Specification for Nitrile Examination Gloves for Medical Application¹. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are powder free gloves.
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K Number
K021041Device Name
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
Manufacturer
Date Cleared
2002-07-30
(120 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
W.A. RUBBERMATE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WA Rubbermate Powder-Free Latex Examination Gloves are 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
WA Rubbermate Powder Free Latex Examination Gloves
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K Number
K971200Device Name
W.A.
Manufacturer
Date Cleared
1997-08-29
(150 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
W.A. RUBBERMATE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Device Description
Powder Free Latex Patient Examination Gloves
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