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510(k) Data Aggregation
K Number
K034060Device Name
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)
Manufacturer
Date Cleared
2004-02-06
(37 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HONG HUANG TANG INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)
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K Number
K974334Device Name
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-01-09
(52 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HONG HUANG TANG INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Device Description
Disposable Powder Free Vinyl Polyurethane Coated Examination Gloves
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K Number
K962026Device Name
PREPOWDER VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
1996-09-10
(110 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HONG HUANG TANG INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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