Klenzyme
Klenzyme Enzymatic Presoak and Cleaner 1-Gallon Bag, is a highly effective protease-based enzyme that is especially effective in the removal of protein from a wide variety of medical…
Klenzyme Enzymatic Presoak and Cleaner 1-Gallon Bag, is a highly effective protease-based enzyme that is especially effective in the removal of protein from a wide variety of medical devices.
Who Else Makes It
Concentrated in Guangdong (26), Zhejiang (7), Jiangsu (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Heearly Technology Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Xiamen Atyou Health Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
Showing 12 of 48. All 48 manufacturers in China registered for Cleaner, Ultrasonic, Medical Instrument
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | FLG |
| Device type | Cleaner, Ultrasonic, Medical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6150 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
| Record revised | 2026-05-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 4 |
| Distribution end date | 2026-05-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1673BXEC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 49 |
| Prolystica | Steris Corporation | 41 |
| Ultra Clean Systems | Getinge Disinfection AB | 33 |
| Henry Schein | Henry Schein, Inc. | 33 |
| Steelco | Steelco SPA | 16 |
| BrandMax Tri-Clean | Brandmax | 12 |
| Alconox | Alconox, LLC | 11 |
| Valsure | Steris Corporation | 11 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 10 |
| Detojet | Alconox, LLC | 9 |
| Liquinox | Alconox, LLC | 8 |
| Citranox | Alconox, LLC | 8 |
Showing 12 of 834. All products under Cleaner, Ultrasonic, Medical Instrument
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-11-19 | Class II | Device Design | STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to u | 23,445 units, Domestic 5,727 units, Foreign 17,718 units | 2023-10-25 |
| 2020-06-26 | Class II | Process control | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. | 1283 | 2020-12-22 |
| 2006-06-22 | Not classified | Other | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire. | 322 units | 2007-01-08 |
| 2006-06-22 | Not classified | Other | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire. | 353 units | 2007-01-08 |
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.