Disposable Thermometer Cover and Sheaths

FDA UDI

Class II (US FDA UDI)

by Kang Ze Industrial Co., Ltd

Identity

Trade Name: Disposable Thermometer Cover and Sheaths FDA UDI
Generic Name: Electronic thermometer probe cover FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 9028 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 06972543480110 FDA UDI
510(k) Number: K112289 FDA UDI
FDA Product Code: FLK FDA UDI
FLL FDA UDI
GMDN Term: Electronic thermometer probe cover FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2920 FDA UDI
880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Electronic thermometer probe cover

Disposable Thermometer Cover and Sheaths by Kang Ze Industrial Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K112289 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Kang Ze Industrial Co., Ltd

Sources (1)

FDA UDI 85bdd233-d4fe-49c3-9336-da887b05c8a2 35 fields · synced Jun 6, 2026