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510(k) Data Aggregation
K Number
K011407Device Name
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
Manufacturer
Date Cleared
2001-09-11
(145 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SEMPERMED USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K011749Device Name
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
Manufacturer
Date Cleared
2001-08-22
(83 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SEMPERMED USA, INC.
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 examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Device Description
Latex Patient Examination glove , Powder Glove (Single side polymer coated) , non sterile 200 micrograms or less of total water extractable protein per gram
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