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Found 11 results
510(k) Data Aggregation
K Number
K142570Device Name
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2014-12-18
(97 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
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K Number
K142571Device Name
Powder Free Vinyl Patient Examination Gloves
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2014-12-17
(96 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Vinyl Patient Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
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K Number
K102655Device Name
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE)
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2010-10-29
(44 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K082029Device Name
SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2008-09-26
(71 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-06.
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K Number
K063214Device Name
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-12-08
(46 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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K Number
K063215Device Name
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-12-08
(46 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.
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K Number
K063213Device Name
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-12-05
(43 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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K Number
K060785Device Name
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-07-07
(107 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
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 hand of healthcare and similar personnel to prevent contamingtion between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vert Creen Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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K Number
K060786Device Name
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-05-08
(47 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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K Number
K060784Device Name
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
Manufacturer
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
Date Cleared
2006-05-01
(40 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves. 80 LYZ. and meets all requirements of ASTM standard D-5250-00E4.
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