Search Results
Found 4 results
510(k) Data Aggregation
K Number
K010247Device Name
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-02-06
(11 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI CHINASTAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K003675Device Name
SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-01-09
(41 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI CHINASTAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K992206Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-07-29
(29 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI CHINASTAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
Ask a Question
Ask a specific question about this device
K Number
K992205Device Name
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-07-23
(23 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI CHINASTAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A glove 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 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
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Ask a Question
Ask a specific question about this device
Page 1 of 1