Probe Covers for Thermometers
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K180714
Overview
The Probe Covers for Thermometers (K180714) are sterile, single-use protective barriers designed to cover the probe tips of thermometers. These covers serve as a barrier during oral or rectal temperature measurements, preventing cross-contamination and ensuring hygiene compliance in clinical settings.
Supplied in non-sterilized packaging, these covers are compatible with various thermometer models and are classified under product code FLL. They received FDA 510(k) clearance under an abbreviated review process, designated for use in general hospital environments. The device is manufactured by K-Jump Health Co., Ltd., with specifications including materials such as polyethylene (PE) and ethylene-vinyl acetate (EVA)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180714 | Date24 Sep 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from K-jump Health Co., Ltd.
Questions
Are these probe covers meant for reuse, or are they designed for single-use only? Why does that matter?
These probe covers are explicitly designed for single-use only. The manufacturer emphasizes their role as a protective barrier to prevent cross-contamination during oral or rectal temperature measurements, which is only safe if the cover is discarded after one use. Reusing them could compromise hygiene and violate clinical infection control protocols, as they are not sterilized post-use.
What types of thermometers are compatible with these probe covers, and how do I know if my device will work?
The covers are universally compatible with various thermometer models, as stated in the description. They are designed to fit standard probe tips commonly used in clinical settings. To confirm compatibility, check if your thermometer’s probe tip has a diameter that aligns with the cover’s opening—most standard digital or disposable thermometers should fit, but always verify the physical fit before use.
Are the probe covers sterile when they arrive, or do I need to sterilize them myself before use?
The covers are sterile upon packaging, but the packaging itself is not sterilized. This means the covers are individually sterile, but the outer packaging may not be. Always handle them with sterile technique (e.g., peel open with gloved hands) to maintain sterility before application. The sterile barrier is only valid for the single-use cycle.
What materials are the probe covers made from, and why does that matter for clinical use?
The covers are made from polyethylene (PE) and ethylene-vinyl acetate (EVA), both of which are non-toxic, flexible, and durable materials commonly used in medical barriers. These materials provide a tight seal over the probe tip while remaining easy to apply and remove, reducing the risk of contamination. Their composition also ensures they won’t degrade or leach harmful substances during use.
How should I store these probe covers to ensure they remain effective and sterile until use?
Store the covers in a cool, dry place away from direct sunlight or extreme temperatures, as recommended for most medical barriers. Keep the packaging intact until use to preserve sterility. Avoid storing them in areas with high humidity or chemical exposure, as this could compromise the material integrity or introduce contamination risks. Once opened, use immediately to prevent exposure to airborne particles.