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510(k) Data Aggregation
K Number
K974371Device Name
CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
Manufacturer
CLK INTL., INC.
Date Cleared
1998-04-21
(152 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CLK INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable device intended for medical purposes that is worn on the examiner's hand(s) or finger(s) to prevent contamination between patient and examiner.
Device Description
Product is a light and flexible glove, in standard sizes, for use in examination procedures, sold non-sterile and intended to be disposed of after use with each patient.
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K Number
K974301Device Name
CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER
Manufacturer
CLK INTL., INC.
Date Cleared
1998-02-06
(81 days)
Product Code
ITX
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
CLK INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.
Device Description
These devices are latex sheaths, closely related to condoms which have been used in the past for this purpose. However, these sheaths have different dimensions, depending on which probe they are designed to be used. They may range in size from about 30 cm. length, and 10 cm. in diameter to 6 cm. in length to 2 cm. in diameter with the 20 cm x 5 cm being the most common.
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