GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing its wings or feathers. MAR 2 3 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Ho Weng Fatt Managing Director Rosner Mautby Meditrade (Thailand) Limited 199 Moo11 Tambon Banpru Hatyai, Songkhla 90250 THAILAND Re: K040448 Trade/Device Name: Gentle Skin and (Multiple Labels) Powder Free, Polymer Coated Glove (With Protein Label Claim) (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Parent Examination Glove Regulatory Class: I Product Code: LLY Dated: February 20, 2004 Received: February 20, 2004 Dear Mr. Fatt: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices markcted in interstate commerce prior to May 28, 1976, the cnactment 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (sec above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Ms. Rivkowich Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-5618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Attachment II Rosner-Mauthy Meditrade (Thailand) Ltd. 510(K) Premarker Natification Patient Examination Cloves, Latex, Powder Free, Polymer Coated With Protein Claim ## INDICATION FOR USE Rosner Mautby Meditrade (Thailand ) Ltd. Applicant : 199 Moo 11 Tambon Banpru Hatyai, Songkhla 90250 Thailand 510 (k) Number : K 040448 : Gentle Skin and (multiple labels) Powder Free, Polyment Device Name Coated Glove (With Protein Label Claim)/ 50 ml Indication For Use : The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between the patient and the examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED) Concurrence of CDRH, Office of Device Evaluation (ODE) Martha T. O'Lone (Div/sion Sign-Division of Anesthesiology, General Ho Infection Control, Dental 510(k) Number: K040448