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510(k) Data Aggregation
K Number
K043014Device Name
POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
SHIJIAZHUANG TILLOTSON RUBBER PRODUCTS CO., LTD.
Date Cleared
2005-01-28
(87 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG TILLOTSON RUBBER PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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, Patient Examination Glove, 80LYY, and meets all requirements of ASTM Standard D 3578-01aE2.
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K Number
K042378Device Name
NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
Manufacturer
SHIJIAZHUANG TILLOTSON RUBBER PRODUCTS CO., LTD.
Date Cleared
2004-09-20
(19 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG TILLOTSON RUBBER PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
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