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Found 8 results
510(k) Data Aggregation
K Number
K210463Device Name
Thermoplastic Elastomer (TPE) Hybrid Examination Glove
Manufacturer
Date Cleared
2022-01-23
(341 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Xuzhou Full Sun Medical Products Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Device Description
Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a patient examination glove made from polyethylene resin and styrene-ethylene-styrene (SEBS) compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
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K Number
K111240Device Name
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
Manufacturer
Date Cleared
2011-07-14
(72 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Powder free vinyl patient examination gloves, non sterile that meets all of the requirements of ASTM --standard-D-5250-06
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K Number
K072377Device Name
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
Manufacturer
Date Cleared
2007-12-14
(112 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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K Number
K071122Device Name
DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
Manufacturer
Date Cleared
2007-12-12
(233 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 801.VZ, and meets all requirements of ASTM Standard D5250-06
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K Number
K072314Device Name
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
Manufacturer
Date Cleared
2007-12-12
(117 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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K Number
K072472Device Name
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
Manufacturer
Date Cleared
2007-10-25
(51 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06
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K Number
K072401Device Name
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
Manufacturer
Date Cleared
2007-10-15
(49 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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K Number
K071123Device Name
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
Manufacturer
Date Cleared
2007-07-30
(98 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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