POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the letters "WRP" in bold, white font against a black, hexagonal background. The letters are large and take up most of the space within the hexagon. The logo is simple and eye-catching, with a clear contrast between the text and the background. K024130 # SPECIAL 510(k) SUMMARY 1 4 7 8 1 7 V #### 1.0 Submitter: # DEC 3 0 2002 | Name: | WRP Asia Pacific Sdn Bhd | |------------|-------------------------------------------------------------------------------------------------------------| | Address: | Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi,<br>43900 Sepang, Selangor Darul Ehsan, MALAYSIA | | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | 1 3 DEC 2002 Date of Summary Prepared: #### 2.0 Contact Person: | Name: | Mr. Terence Lim | |------------|-----------------| | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | #### 3.0 Modified Device Identification: | Trade Name: | 1) | Comfit, and | |----------------------|-----------------------------------------------------------------------|-----------------------------------| | | 2) | Multiple or Customers' Trade Name | | Device Name: | Powder Free Polymer Coated Green Neoprene Surgical<br>Gloves, Sterile | | | Common Name: | Surgical Gloves | | | Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) | | ### 4.0 Identification of the Legally Marketed Device: Class I Powder Free synthetic rubber latex surgeon's gloves, 79KGO, that meets all the requirements of ASTM standard D 3577 - 01a22 Type 2 and FDA 21 CFR 800.20. #### Description of Device Modification: 5.0 The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile is equivalent to the existing model, i.e. Profeel Powder Free Polymer Coated Neoprene Surgical Gloves, Sterile which had submitted and cleared under 510(k) number K003019. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the letters "WRP" in white, set against a black, hexagonal background. The letters are bold and sans-serif, filling most of the space within the hexagon. The logo has a simple, clean design, making it easily recognizable. WRP Asia Pacific Sdn Bhd The difference in this submission is: - Change of colour additive used, i.e. Green a) 1 4 7 8 1 7 V The modification of colour does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections. The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile meets all the requirements of ASTM standard D 3577 -- 01a52 and FDA 21 CFR 800.20. #### 6.0 Intended Use of the Device: The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment. #### 7.0 Summary of Technological Characteristics for the Modified Device: The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |-----------------------|------------------------------------------|-----------------------| | Dimensions | ASTM D 3577 - 01aE2 | Meets | | Physical Properties | ASTM D 3577 - 01aE2 | Meets | | Freedom from pinholes | ASTM D 3577 - 01aE2<br>FDA 21 CFR 800.20 | Meets | | Powder Residual | ASTM D 6124 - 01 | Meets<br>< 2 mg/glove | #### 8.0 Conclusion: The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. # DEPARTMENT OF HEALTH & HUMAN SERVICES 9200 Corporate Boulevard Rockville MD 20850 Mr. Terence Lim Associate Manager, RA/QA WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA Re: K024130 Trade/Device Name: Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile Regulation Number: 21 CFR 878.4460 Regulation Name: Surgical Gloves Regulatory Class: I Product Code: KGO Dated: December 13, 2002 Received: December 16, 2002 ### Dear Mr. Lim: 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. {3}------------------------------------------------ Page 2 - Mr. Lim 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 (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). 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, Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters "WRP" in white against a black, rounded rectangle. The letters are bold and sans-serif, and they are stacked vertically. The logo is simple and clean, with a high contrast between the letters and the background. The rounded rectangle shape gives the logo a modern and approachable feel. # Asia Pacific Sdn Bhd # INDICATIONS FOR USE Applicant: WRP Asia Pacific Sdn Bhd 510(k) Number (if known): K024130 Device Name: # POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE Page 1 of 1 Indications For Use: The surgical glove is a device made of synthetic 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) | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter | |------------------------------------------|----|------------------| |------------------------------------------|----|------------------| Clean S. Lim (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | 510(k) Number | K024130 | |---------------|---------| |---------------|---------| Valur Dartnor In Dratarting