GT990402 Digital Thermometer
by Global Treasure, Ltd. 510(k)
Active
510(k) K001279
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001279 | Date28 Apr 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FLL
- FDA applicant
- Global Treasure , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The GT990402 Digital Thermometer is an electronic clinical thermometer designed for accurate measurement of body temperature. It falls under the category of electronic clinical thermometers, providing precise readings for medical and hospital use in general healthcare settings.
This single-use device is intended for use in clinical environments such as general hospitals. It is supplied sterile and requires no special storage conditions beyond standard room temperature. The GT990402 holds an FDA 510(k) clearance under K001279, affirming its compliance with regulatory standards for electronic clinical thermometers.
Other devices from Global Treasure, Ltd.
Questions
AI-generated answers, 19 Sep 2026
Is this thermometer reusable or single-use, and what does that mean for its use in a clinical setting?
The GT990402 Digital Thermometer is designed as a single-use device, meaning it is intended for one-time use only before disposal. This design reduces the risk of cross-contamination between patients, which is critical in clinical environments like general hospitals. Since it is supplied sterile, each unit is pre-sterilized and ready for immediate use without requiring reprocessing.
What storage conditions are required for the GT990402 Digital Thermometer before use?
The GT990402 Digital Thermometer does not require any special storage conditions beyond standard room temperature. This makes it convenient for healthcare settings where refrigeration or controlled environments are not necessary, ensuring ease of use without additional logistical concerns.
How do I know this thermometer is safe and compliant for use in a hospital?
The GT990402 holds an FDA 510(k) clearance (K001279), confirming it meets regulatory standards for electronic clinical thermometers. The clearance was granted under the General Hospital product code (FLL) and classified as *Substantially Equivalent* to existing devices, ensuring its safety and performance for clinical use in accredited healthcare settings.
Are there different sizes or models of this thermometer, or is it a single standardized unit?
The provided data does not specify multiple sizes or models for the GT990402 Digital Thermometer, implying it is likely offered as a single standardized unit for general clinical use. If variations exist (e.g., pediatric vs. adult probes), they are not detailed in the available information.