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510(k) Data Aggregation
K Number
K213306Device Name
Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
Manufacturer
Date Cleared
2022-02-18
(137 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zibo Sinocare Plastic Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Device Description
The powder free Nitrile Examination glove is a disposable Class 1 medical device made of Nitrile rubber, and is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The principal 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
K051723Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW)
Manufacturer
Date Cleared
2005-07-15
(18 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl 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
powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084.
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K Number
K051148Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2005-06-21
(48 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl 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
powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.
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K Number
K051152Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
Manufacturer
Date Cleared
2005-06-03
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
powdered vinyl 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
powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.
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