POWDERFREE LATEX SURGEON'S GLOVES

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter 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 ## FEB 0 6 2002 Mr. Ravi Abraham Managing Director Kanam Latex Industries PVT. Limited Ooppoottil Buildings K.K. Road, P.O. Box 28, Kottayam, Kerala-686 001 INDIA Re: K013914 Trade/Device Name: Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: November 12, 2001 Received: November 27, 2001 Dear Mr. Abraham: 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 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) 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 (see 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 - Mr. Abraham 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 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, Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## KANAM LATEX INDUSTRIES PRIVATE LIMITED ISO 9002 Certified Company : Reg. & Sales Office : Ooppoottil Buildings, P.O. Box No.28, K.K. Road, Kottayam - 686001. Kerala Ph. : 300343, Telex : 0888 - 281 Optl in. Fax No.91 - 481 - 563614 e-mail - kanam @ md2.vsnl.net.in website - www. kanamlatex.com Factory : West Peruvitai, Pallavilai, Nagercoil - 629 003. Tamil Nadu, S. India. TNGST No. 6160681. CST : 461477 Dt.6.1.1987 Image /page/2/Picture/5 description: The image is a black and white logo for Surgicare. The logo features a pair of hands wearing surgical gloves. The hands are positioned in a way that suggests they are performing a delicate procedure or handling surgical instruments. ## INDICATIONS FOR USE APPLICANT KANAM LATEX INDUSTRIES PVT LTD 510 (K) NO DEVICE NAME DERFREE LATEX SURGEON'S GLOVES WITH EIN CONTENT LABELING CLAIM (50 MICROGRAMS ## INDICATIONS FOR USE. A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use √ (Optional Format 1-2-96) Bissell for Clin vision Sign-Off) ാസ്ട്രോസ് വിവാഹം and General Hospital Devices * ( 18) Number -