Disposable Thermometer Cover and Sheaths
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…
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.
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| China (Shenyang) MED-Land IMP/EXP Corp., Ltd. | Shanghai | Shanghai | Exporter | 32 |
| Jiangsu Prospect Healthcare Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 13 |
| JWD. Technologies (Jiangmen) Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 12 |
| DU-Hope International Group | Nanjing | Jiangsu | Contract manufacturer | 11 |
| Joytech Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Kang ZE Industrial Co., Ltd. | Dongguan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Kang ZE Industrial Co., Ltd., China |
|---|---|
| FDA product code | FLK |
| Device type | Thermometer, Clinical Mercury |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2920 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K112289 |
| Record published | 2019-08-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 12028 | 5,000 | In distribution | |
| 9028 | 21,600 | In distribution | |
| 9225 | 30,000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Geratherm Mercury Free Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 3 |
| Geratherm | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Bios Diagnostics | Thermor Ltd. | 1 |
| Geratherm Magnatherm Mercury Clinical Free Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Mercury Free Glass Hypothyroid Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Magnatherm Mercury Free Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Mercury Free Basal Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Mercury Free Glass Oral Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm® classic | Geratherm AG | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.