LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three parallel lines curving upwards, resembling a bird in flight or a stylized representation of human figures. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### DEC 0 7 2001 Mr. Rajeev K. Sood President Innovative Gloves Company Limited 11 Chotevittayakul 3 Road Hatyai, Songkhla, THAILAND Re: K013333 K015355 Trade/Device Name: Latex Examination Gloves Powderfree Polymer Coated with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: September 22, 2001 Received: October 9, 2001 Dear Mr. Sood: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviowed your becares is see the device is substantially equivalent (for the icelerenced above and have acternines to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Anticincinents, or to do roses and Cosmetic Act (Act) that do not require approval of a premarket the Fouchal I out, Drag, and Coournay, therefore, market the device, subject to the general approvin application (1 Million ) . The general controls provisions of the Act include controls providents of an 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 If your device is chabition (200 as additional controls. Existing major regulations affecting (1 Mry, it may of subject to Back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the be announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 and insting (Dr Cr read 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 and additionally 21 CFR Part 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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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, Alatout Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # บริษัท อินโนเวทีนใ โทลฟฟส์ จากัต INNOVATIVE GLOVES CO.,LTD. 500 หมู่ 4 ต.ควนลัง อ.หาดใหญ่ จ.สงขลา 90110 500 Moo 4 T.Kuanlang, A.Hatyai, Songkhla 90110 Tel : (074) 474730-3 Fox : (074) 474734 #### INDICATIONS FOR USE ## Applicant's Name: INNOVATIVE GLOVES CO., LTD. 510 (K) Number (if known): Device Name: LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM ( 50 MICROGRAMS OF LESS) INDICATIONS FOR USE: A patient examination glove is a disposable device intended for medical purpose than worn on the examiner's hands or fingers to prevent contamination between patient ar. examiner. (21 CER 880.6250) Qian S. Lin (Division Sign-Off) (Division of Dental, Infection Control, Bivisor General Hospital Device ក្រ (k) Number –