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510(k) Data Aggregation
K Number
K112289Device Name
DISPOSABLE THERMOMETER COVERS AND SHEATHS
Manufacturer
KANG ZE INDUSTRIAL CO. LIMITED
Date Cleared
2011-12-16
(129 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
KANG ZE INDUSTRIAL CO. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
Device Description
The Disposable Thermometer Covers and Sheaths, made of PE and EVA, are used for either oral or rectal measurements for digital or mercury thermometers. The products and packaging are non-sterile and are not made with natural rubber latex. The size may vary to accommodate differences in digital and mercury thermometers. The inner packing material is paper, while the outer packing material is carton. Each outer packing contains 100 pieces of covers and sheaths.
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