← Product Code [LRJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LRJ) · K981023 # KLEENASEPTIC (K981023) _Metrex Research Corp. · LRJ · Apr 30, 1998 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LRJ/K981023 ## Device Facts - **Applicant:** Metrex Research Corp. - **Product Code:** [LRJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LRJ.md) - **Decision Date:** Apr 30, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6890 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Kleenaseptic is a general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important. Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C). ## Device Story Kleenaseptic is a ready-to-use, spray-on chemical disinfectant; formulation consists of isopropyl alcohol and quaternary ammonium compounds. Used in hospitals and critical care areas for cleaning and disinfecting equipment surfaces and non-critical medical devices. Applied by healthcare personnel to surfaces; requires 10-minute contact time at room temperature (69°F/20°C) to achieve disinfection. Acts as an environmental control measure to reduce cross-contamination risk. Product is marketed for over-the-counter use. ## Clinical Evidence No clinical data provided; substantial equivalence is based on EPA registration and compliance with FDA guidance for general purpose disinfectants. ## Technological Characteristics Chemical disinfectant; ready-to-use spray formulation; active ingredients: isopropyl alcohol and quaternary ammonium compounds. No electronic, mechanical, or software components. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for "SYBRON DENTAL SPECIALTIES, INC." The word "SYBRON" is in large, bold, sans-serif font. Below it, "DENTAL SPECIALTIES, INC." is in a smaller, sans-serif font. The text is black against a white background. # SUMMARY OF SAFETY Submitter: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7425 - Phone (714) 516-7488 - Facsimile Wendy A. Urtel - Contact Person Date Summary Prepared: March 1998 ## Device Name: - . Trade Name - Kleenaseptic - Common Name General Purpose Disinfectant ● - . Classification Name - Unclassified ### Device Description: Kleenaseptic is a ready-to-use, spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices prior to terminal sterilization/high-level disinfection in healthcare environments. ### Intended Use of the Device: Kleenaseptic is a general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important. Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C). ### Substantial Equivalence: The basis for determination of substantial equivalence for Kleenaseptic, a general purpose disinfectant, is its EPA registration as demonstrated by the assignment of EPA registration number 46781-7 and the EPAstamped approved label. This submission is in conformance with the FDA "Guidance on the Content and Format of 510(k) Submission for General Purpose Disinfectants'', October 1993. The Guidance allows for a 510(k) in order to carry out the intent of the Memorandum of Understanding (MOU) between the EPA and FDA dated June 4, 1993 and amended June 2, 1994. The MOU is an interim agreement between the two agencies regulating the same products. SYBRON DENTAL SPECIALTIES, INC. 1717 W COLLINS AVENUE, ORANGE. CALIFORIA 92667 (114) 516-7400 A SUBSIDIARY OF SYBHON INTERNATIONAL Primal on Resulted Paper {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. ! Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 3 0 1998 Metrex Research Corporation C/O Ms. Wendy A. Urtel Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92667 Re : K981023 Trade Name: Kleenaseptic Requlatory Class: . Unclassified . . . Product Code: LRJ Dated: March 17, 1998 March 19, 1998 Received: Dear Ms. Urtel: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A. . . . . substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {2}------------------------------------------------ Page 2 - Ms. Urtel the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications for Use 510(k) Number: K981023 Device Name: Kleenaseptic Indications for Use: Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important. Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C). (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Chun S. Lim (Division Sign-Off) Division of Denal, Infection Control, and General Hospital Devices 510(k) Number K981023 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use X (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LRJ/K981023](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LRJ/K981023) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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