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510(k) Data Aggregation
K Number
K102846Device Name
PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2011-03-17
(169 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
THAI HUA HOLDING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Gloves (Blue), non-sterile.
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K Number
K102840Device Name
PATIENT EXAMINATION GLOES
Manufacturer
Date Cleared
2011-02-18
(142 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
THAI HUA HOLDING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder-Free Polymer Coated Latex Examination Gloves with Protein Labeling (50microgram or less of total water extractable proteins per square decimeter of gloves), non-sterile.
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K Number
K102838Device Name
PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2011-02-03
(127 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
THAI HUA HOLDING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powdered Latex Examination Gloves. non-sterile.
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Ask a specific question about this device
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