Digital Thermometer Sheaths (Oral and Rectal)
by Abco Dealers, Inc. 510(k)
Active
510(k) K882304
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882304 | Date12 Jul 1988 | 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- Withdrawn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
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Digital Thermometer Sheaths are protective covers designed for use with digital thermometers. These sheaths are intended to facilitate the hygienic use of thermometers during oral and rectal temperature measurements.
This device is supplied as a single-use product to assist in maintaining cleanliness. It is subject to FDA 510(k) clearance under K882304.
Other devices from Abco Dealers, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the intended use of these thermometer sheaths?
These sheaths are protective covers designed to facilitate hygienic temperature measurements. They are intended for use with digital thermometers during both oral and rectal procedures to assist in maintaining cleanliness.
Are these thermometer sheaths reusable?
No, these sheaths are supplied as a single-use product. This design ensures that a fresh, clean barrier is used for each measurement to maintain hygiene standards.
What is the regulatory status of this device?
This device has received FDA 510(k) clearance under K882304. This indicates that the product has been reviewed and found to be substantially equivalent to legally marketed predicate devices.