LRJ · Disinfectant, Medical Devices
General Hospital · 21 CFR 880.6890 · Class 1
Overview
| Product Code | LRJ |
|---|---|
| Device Name | Disinfectant, Medical Devices |
| Regulation | 21 CFR 880.6890 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 73)
Showing 20 most recent of 73 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992661 | CONTROL III ELITE | Maril Products, Inc. | Sep 14, 1999 | SESE |
| K991509 | PRO-PORTION CLEANER/DISINFECTANT | Sultan Chemists, Inc. | Jul 14, 1999 | SESE |
| K984485 | MICROSTAT 2 | Chemlink Laboratories, LLC | Jan 13, 1999 | SESE |
| K983947 | AMERSE 2 | STERIS Corporation | Dec 4, 1998 | SESE |
| K983869 | DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH | Caltech Industries, Inc. | Nov 30, 1998 | SESE |
| K983585 | LOW PH PHENOLIC 256 | Central Solutions, Inc. | Nov 6, 1998 | SESE |
| K982985 | CITREX HOSPITAL SPRAY DISINFECTANT | Caltech Industries, Inc. | Nov 2, 1998 | SESE |
| K981023 | KLEENASEPTIC | Metrex Research Corp. | Apr 30, 1998 | SESE |
| K980369 | T.B.Q. RTU | STERIS Corporation | Feb 17, 1998 | SESE |
| K974304 | GERMICIDAL CLOTH | Convatec, A Division of E.R. Squibb & Sons | Jan 13, 1998 | SESE |
| K961044 | NOVIGUARD QUICK DRY | Dr. Novis Smith & Co., Inc. | Jul 3, 1997 | SESE |
| K970825 | BLUE CHIP GERMICIDAL CLEANER & DEODORANT | S.C. Johnson Professional | Mar 14, 1997 | SESE |
| K964376 | CIDE-SWIPES P-100B & CIDE-SWIPES C-100A | Mp Scientific, Inc. | Dec 23, 1996 | SESE |
| K964828 | VIREX II 128 GERMICIDAL CLEANER AND DEODORANT | S.C. Johnson & Son, Inc. | Dec 19, 1996 | SESE |
| K964835 | COVERAGE SPRAY HBV | Convatec, A Division of E.R. Squibb & Sons | Dec 16, 1996 | SESE |
| K964749 | COVERAGE HBV | Convatec, A Division of E.R. Squibb & Sons | Dec 13, 1996 | SESE |
| K964613 | VIREX II 256 GERMICIDAL CLEANER AND DEODORANT | S.C. Johnson & Son, Inc. | Dec 13, 1996 | SESE |
| K964610 | TRIAD II DISINFECTANT CLEANER AND DEODORANT | S.C. Johnson & Son, Inc. | Dec 13, 1996 | SESE |
| K964535 | VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT | S.C. Johnson & Son, Inc. | Dec 13, 1996 | SESE |
| K963353 | LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) | Reckitt Benckiser, Inc. | Oct 18, 1996 | SESE |
Top Applicants
- Central Solutions, Inc. — 7 clearances
- Huntington Laboratories, Inc. — 6 clearances
- Calgon Vestal Div. — 5 clearances
- Caltech Industries, Inc. — 5 clearances
- Sporicidin Intl. — 5 clearances
