POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the letters "VWRP" in a stylized font. The "V" is large and bold, with a design that suggests movement or flow. The letters "WRP" are smaller and placed to the right of the "V", creating a sense of balance in the logo. The logo is in black and white. K670619 # SPECIAL 510(k) SUMMARY # JUN 2 7 2007 #### 1.0 Submitter: | 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 1557 | Date of Summary Prepared: 28 FEB 2007 #### 2.0 Contact Person: | Name: | Mr. Kirk Penner | |------------|--------------------------| | Phone No.: | +60 3 8706 1486 Ext. 148 | | Fax No.: | +60 3 8706 1557 | #### 3.0 Device Identification: | Trade Name: | 1) Eudermic, and<br>2) Multiple or Customers' Trade Name | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Powder Free Polymer Coated Brown Latex Surgical Gloves,<br>Sterile, Coated with Aloe Vera and with Protein Content<br>Labeling Claim (50 micrograms or less) | | 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 natural rubber latex surgeon's gloves, 79KGO, that meets all the requirements of ASTM standard D 3577 - 06 Type 1 and FDA 21 CFR 800.20. #### 5.0 Description of the Device: The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim is equivalent to the existing model, i.e. Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) Contains 50 Micrograms or Less of Total Water Extractable Protein per gram which had submitted and cleared under 510(k) number K021784. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the letters "WRP" in bold, black font. To the left of the letters is a stylized graphic that resembles a "V" shape, also in black. The graphic is made up of two thick, curved lines that converge at the bottom, creating a sense of movement or flow. The overall design is simple, bold, and modern. The difference in this submission is: - With Aloe Vera coated on surgical gloves. a) The modification of device 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 Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3577 - 06 and FDA 21 CFR 800.20. #### 6.0 Intended Use of the Device: The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim are made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. #### 7.0 Summary of Technological Characteristics for the Modified Device: The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |-----------------------|---------------------------------------|-----------------------------------------| | Dimensions | ASTM D 3577 - 06 | Meets | | Physical Properties | ASTM D 3577 - 06 | Meets | | Freedom from pinholes | ASTM D 3577 - 06<br>FDA 21 CFR 800.20 | Meets | | Powder Residual | ASTM D 6124 - 06 | Meets<br>< 2 mg/glove | | Protein Level | ASTM D 5712-99 | < 50 µg/g | | Biocompatability | Primary Skin Irritation in Rabbits | Passes<br>(Not a primary skin irritant) | | | Dermal Sensitization | Passes<br>(Not a contact sensitizer) | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters "WRP" in bold, black font. To the left of the letters is a stylized graphic that resembles a "V" shape, also in black. The graphic has a textured appearance, with some areas appearing slightly faded or pixelated. The overall impression is of a professional and established brand identity. #### 8.0 Conclusion: n ' : and the comments of The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim 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. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 2 7 2007 Mr. Kirk Penner Head of Department, Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan MALAYSIA Re: K070619 Trade/Device Name: Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 21 CFR 880.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: June 4, 2007 Received: June 13, 2007 Dear Mr. Penner: 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. {4}------------------------------------------------ ## Page 2 - Mr. Penner 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sagite y. Michie Ows. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ### Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters "VWRP" in a bold, stylized font. The letters are black and appear to have a textured or slightly distressed effect. The "V" and "W" are connected, creating a unique visual element, while the "R" and "P" are separate. The overall design is simple yet impactful, suggesting a strong and established brand identity. ### INDICATIONS FOR USE Applicant: WRP Asia Pacific Sdn Bhd 510(k) Number (if known): \$\mathcal{A} \mathcal{K} 70619 Device Name: POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, WITH ALOE VERA AND WITH COATED PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) 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) Sheela H. Murphy/10 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices OR 510(k) Number: K070614 Prescription Use (Per 21 CFR 801.109) Over-The-Counter Page 1 of 1