POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 5 2003 Mr. Joseph J. E. Pereira Primus Gloves Private Limited 14-A, Cochin Special Economic Zone Kakkanad, Cochin, Kerala, INDIA 682 037 Re: K030445 Trade/Device Name: Powder Free Latex Microsurgery Gloves with Brown Color and Protein Labeling Claim of 50 Micrograms or Less Protein Gram Regulation Number: 878.4460 Regulation Name: Surgeon’s Glove Regulatory Class: I Product Code: KGO Dated: May 5, 2003 Received: May 12, 2003 Dear Mr. Pereira: 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. Pereira 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) 594-4618. 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,  Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Primus PRIMUS GLOVES (P) Limited Plot No. 14-A, Cochin Special Economic Zone, European Office: Kakkanad, Cochin - 682 037, Kerala, India Goldberg 16, D-23562, Tel: 91-484-2413063, 2413076, Fax: 91-484-2413089 Lubeck, Germany Email: primusgl@vsnl.com; primusgloves@eth.net; Tel + 49 - 451 - 5823540 primusgl@specf .net.in Fax: + 49 - 451 - 5823541 www.primusg s.com Email: Primusgermany@aol.com $K030445$ ## ENCLOSURE-II ## INDICATIONS FOR USE APPLICANT : PRIMUS GLOVES PRIVATE LIMITED 510 (k) NO : --- DEVICE NAME : POWDERFREE LATEX MICROSURGERY GLOVES BROWN COLOR INDICATIONS FOR USE. A Surgeons glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.