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Found 5 results
510(k) Data Aggregation
K Number
K090336Device Name
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
Manufacturer
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
Date Cleared
2009-07-01
(141 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
Device Description
Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
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K Number
K011765Device Name
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
Manufacturer
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
Date Cleared
2001-08-16
(70 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powderfree patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Sunmax Blue Nitrile Powderfree Examination Glove
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K Number
K011717Device Name
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
Manufacturer
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
Date Cleared
2001-08-14
(71 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powdered patient examination glove is a disposable device made of nitrile for medical purposes that is worn upon the hand to prevent contamination between patient and examiner.
Device Description
Sunmax Blue Nitrile Powdered Examination Gloves
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K Number
K964964Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
Date Cleared
1997-02-07
(58 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960746Device Name
SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
Manufacturer
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
Date Cleared
1996-06-27
(125 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUNMAX ENTERPRISE SHANGHAI CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel the patient's body, and fluids, waste or environment.
Device Description
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
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