POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed in a black, rounded shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar bold, sans-serif font. Below the text is the number 147817V. JUL 0 5 2002 ## 510 (K) SUMMARY OF POWDERED BROWN LATEX SURGICAL GLOVES, STERILE The device in this 510(k) submission is the Powdered Brown Latex Surgical Gloves. Sterile which is made of natural rubber latex. These gloves are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The Powdered Brown Latex Surgical Gloves, Sterile are substantially equivalent to Microptic, Brown Beaded Surgeon's Gloves (Powdered, Hypoallergenic) submitted and cleared under 510(k) number K960416. The only difference in this submission is to include the Expiration Date Labeling Claim and Protein Content Labeling Claim with no changes in product design. The results of stability study and protein content test conducted on Powdered Brown Latex Surgical Gloves, Sterile are submitted to support the expiration date labeling claim and protein content labeling claim. Based on the results obtained through out the Stability Test, it can be concluded that the Powdered Brown Latex Surgical Gloves, Sterile produced by WRP Asia Pacific Sdn Bhd has demonstrated that the barrier properties, physical and mechanical properties, packaging integrity and sterility of the gloves are maintained for the duration of the claimed shelf-life (expiration date, i.e. 5 years). Also, based on the protein content test report, the protein level of the gloves is well below 50 us/g and supports our protein content labeling claim. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three intertwined strands forming a shape resembling a bird or abstract human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. K. K Leong Associate Manager, QA/RA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan, MALAYSIA JUL 5 - 2002 Re: K021119 Trade/Device Name: Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim and Protein Content Labeling Claim Regulation Number: 878.4460 Regulation Name: Surgical Gloves Regulatory Class: I Product Code: KGO Dated: April 4, 2002 Received: April 8, 2002 Dear Mr. Leong: 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. {2}------------------------------------------------ ## Page 2 - Mr. Leong 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.qov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy A. Ulatowski Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in white, set against a black oval shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a bold, sans-serif font. Below the company name is the number "147817 V". ## INDICATIONS FOR USE Applicant: WRP Asia Pacific Sdn Bhd KO21119 510(k) Number (if known): Device Name: POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM AND PROTEIN CONTENT LABELING CLAIM Indications For Use: The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. Concurrence of CDRH, Office of Device Evaluation (ODE) Charles (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Page 1 of 1 {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. K. K. Leong Associate manager, QA/RA WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan MALAYSIA Re: K021119 (Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim) K021159 (Powdered Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim) Dear Mr. Leong: This letter notifies you that the data you submitted in your 510(k) submissions for the Powdered Brown latex Surgical Glove, Sterile with Expiration Date labeling Claim (K021119) and Powdered Latex Surgical Gloves. Sterile with expiration Date Labeling Claim (K021159) are inadequate to support a 5 year shelf life. Although FDA has determined that both 510(k)s are substantial equivalent, the shelf life labeling claim is a quality systems issue, not a premarket issue. If you include a 5- year shelf life on your products with the data in the 510(k) submissions, FDA will consider your products misbranded. If you wish to add a 5- year shelf life to the products labeling, please revise the test protocol you intend to use for the study, which should take FDA's July 5, 2002, comments into consideration. Please advise FDA of your intentions no later than July 31, 2002. If you have any questions, please contact Chiu Lin, Ph.D., Branch Chief, Infection Control Devices Branch at 301-443-8913. Sincerely yours, Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health