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Found 6 results
510(k) Data Aggregation
K Number
K022087Device Name
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
Manufacturer
Date Cleared
2002-07-11
(14 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, 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
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
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K Number
K002870Device Name
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
Manufacturer
Date Cleared
2000-10-16
(33 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001611Device Name
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
Manufacturer
Date Cleared
2000-06-30
(36 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001601Device Name
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
Manufacturer
Date Cleared
2000-06-23
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K961521Device Name
PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
1997-01-30
(283 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K963751Device Name
PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
Manufacturer
Date Cleared
1996-10-29
(41 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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