(476 days)
Noviguard is a general purpose disinfectant and is intended to be used on non-critical surfaces such as floors, walls, counter tops, tables, associations and chairs and medical beds in health care facilities.
Noviguard Quick Dry is a specially formulated general purpose disinfectant based on phenol and ortho phenol which are complexed reversibly with a olely/trimethylenediamine (Adogen 572) and another basic polymer(PVP) to form a thin film which contains a high concentration of the phenolic disinfectant when dried. (This permits the use of low levels of phenol in the use solution to be about 0.5% yet when the very thin film dries the percentage of phenol is about 25% as the complex.) The phenol is retained and escapes as if in a slow release situation over week or more. the higher molecular weight components which also are disinfectants remain and maintain an effective disinfecting barrier. This whole formulation is dissolved in ethanol which permits the solution to dry within seconds for fast even application to surfaces. Ethanol does not attack most normally found surfaces in homes or hospitals.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that would be needed to answer your request. The document is a 510(k) summary for a general-purpose disinfectant called "Noviguard Quick Dry," outlining its composition, intended use, and substantial equivalence to a predicate device (Lysol). It includes the FDA's approval letter for marketing the product.
Therefore, I cannot generate the table or provide the detailed information you requested regarding acceptance criteria and a study proving the device meets them.
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JUL - 3 1997
6-1
DR NOVIS SMITH & CO 1034 Laurel Oak Road Voorhees, NJ 08043 800-668-4482 PA (215) 627-3200 Fax (215) 922-1211
510(k) SUMMARY Prepared June 19, 1997
This 510(k) Summary for Noviguard Quick Dry has been prepared by Dr. Novis Smith who can be reached at the place of business noted in the letterhead and is the contact person.
Noviguard Quick Dry is a specially formulated general purpose disinfectant based on phenol and ortho phenol which are complexed reversibly with a olely/trimethylenediamine (Adogen 572) and another basic polymer(PVP) to form a thin film which contains a high concentration of the phenolic disinfectant when dried. (This permits the use of low levels of phenol in the use solution to be about 0.5% yet when the very thin film dries the percentage of phenol is about 25% as the complex.) The phenol is retained and escapes as if in a slow release situation over week or more. the higher molecular weight components which also are disinfectants remain and maintain an effective disinfecting barrier. This whole formulation is dissolved in ethanol which permits the solution to dry within seconds for fast even application to surfaces. Ethanol does not attack most normally found surfaces in homes or hospitals.
We claim equivalence to Lysol which is based on just ortho-phenyl phenol. These are both products with at use concentrations of about 1% or less of active components. Both have been designed for the hospital and the home for primary disinfecting of exposed surfaces against a wide range of organisms. Noviguard Quick Dry is intended to be used as a general purpose disinfectant after cleanup has been accomplished or on surfaces nominally clean to maintain these surfaces in a disinfected state. This is achieved by using two phenols which act more rapidly and have a wider number of organisms which Noviguard would be effective against and in combination with the film forming polymer and olelyl trimethylenediamine. This unique combination permits the application of small amounts of disinfactant to surfaces and yet obtains maximum effectiveness since a rapid effective kill occurs and a longer lasting disinfecting action is maintained.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Novis Smith 'President Frebrache
Dr. Novis Smith & Company, Incorporated >> 701 Haddon Avenue 08108 Collingswood, New Jersey
JUL - 3 1997
K961044 Re: Noviguard Quick Dry Trade Name: Requlatory Class: Unclassified Product Code: LRJ Dated: May 20, 1997 May 21, 1997 Received:
Dear Dr. Smith:
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 abe Beach in to May 28, 1976, the enactment date of the ommorly Device Amendments, or to devices that have been realour books 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 Regulations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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through 542 of the Act for devices under the Electronic chrough 312 or on notrol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberrason in formalence of your device to a legally marketed predicate device results in a classification for your markets productorermits 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene critic or 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
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _______________________________________________________________________________
Indications For Use:
Noviguard is a general purpose disinfectant and is intended to be used on non-critical Noviguard is a general purpose disiniectant and is interious to be associations and chairs and medical beds in health care facilities.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off)Division of Dental, Infection Control,and General Hospital Devices | ||
| 510(k) Number | K961066 | |
| Prescription Use | OR | Over-the-Counter Use |
§ 880.6890 General purpose disinfectants.
(a)
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.(b)
Classification. 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.