PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY 0 8 2002 Mr. Joseph J. E. Pereira Director Primus Gloves Private Limited 14 A, Cochin Special Economic Zone Kakkanad, Cochin, Kerala, INDIA 682 030 Re: K021065 Trade/Device Name: Pre-Powdered Sterile Latex Surgeon's Gloves (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: March 22, 2002 Received: April 2, 2002 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}------------------------------------------------ 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 not invall at 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 i carrat 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 s rotty promate ted 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, Pattare Circuit/fa Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "Primus" in a stylized font. The word is surrounded by an oval shape that encloses the word. The font is bold and appears to be handwritten. The image is in black and white. # PRIMUS GLOVES (P) Limited Plut No. 14-A, Cochin Special Economic Zone. European Office: Kakkanad, Cochin - 682 037, Kerala, India Goldberg 16, D-23562, Tel: 91-484-421983, 423530, Fax: 91-484-424033 Lubeck, Germany Email : primusgl@vsnl.com; primusgloves@eth.net; Tel + 49 - 451 - 5823540 primusgl@spectrum.net.in Fax:+ 49 - 451 - 5823541 www.primusgloves.com Email: Primusgermany@aol.com **ENCLOSURE-II** ## INDICATIONS FOR USE APPLICANT PRIMUS GLOVES PRIVATE LIMITED 510 (k) NO KO21065 DEVICE NAME pre-POWDERED LATEX SURGEON'S Sterile pre-POWDERED LAIEX SORGEON 3 ram one less of Tofol Water Extract able Profess Per Gran #### INDICATIONS FOR USE. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from 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) Qhia S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -