PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)

{0}------------------------------------------------ 3/12/99 Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are enclosed within a thick, black, rounded, and irregular oval shape. The logo appears to be a simple, graphic representation of the company or brand it represents. Kg82600 # WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V) Lot 1. Jalan 3. Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia. Tel: +60 3-8461486 (20 Lines) Marketing/QA Fax: +60 3-8461485/1557 Operations Fax: +60 3-8461488 ### ATTACHMENT 3 CONTACT PERSON : Y. W. CHOW #### 510(k) SUMMARY - PROFEEL SYNTHETIC COPOLYMER SURGICAL 1. Trade Name • GLOVES (POWDERED) - Surgeon's Gloves 2. Common Name : - Surgeon's Glove 3. Classification Name : #### Substantial Equivalence : 4. Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove. The device is identical, and substantially equivalent to the Elastyren Surgical Glove manufactured by ECI Medical Technologies Inc., Canada. It meets all of the requirements of ASTM standard D3577-91 Type 2. #### 5. Description of Device : Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove. The device is identical, and substantially equivalent to the Elastyren Surgical Glove manufactured by ECI Medical Technologies Inc., Canada. It meets all of the requirements of ASTM standard D3577-91 Type 2. #### 6. Intended Use of Device : The gloves are 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. Page 1 of 3 Image /page/0/Picture/19 description: The image shows a black and white emblem or logo. It features a stylized letter 'A' in the center, with a curved shape above it that resembles a roof or arch. The overall design is symmetrical and appears to be a simple, possibly vintage, symbol. Image /page/0/Picture/20 description: The image shows a registered trademark symbol. The symbol is a triangle on top of a circle. The word "REGISTERED" is written inside the circle. Image /page/0/Picture/21 description: The image contains two curved lines that are black in color. The lines are similar in shape and size, and they are positioned next to each other. The lines are slightly thicker at the top and thinner at the bottom. {1}------------------------------------------------ 82600 Performance data of gloves to ASTM D 3577-91 Type 2 and FDA 1000 ml watertight test. | TEST | ASTM D<br>3577-91<br>Type 2 | PROFEEL Synthetic Copolymer Surgical Gloves (Powdered) -<br>refer to Attachment 7 of Device Test Report of Compliance | |----------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------| | 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on<br>1) Single Sampling Plan, S-4, AQL 1.5,<br>2) Multiple Sampling Plan, GII, AQL 2.5 | | 2. Length (mm) | | | | Size | | | | 6½ | min 265 | 301 | | 7 | min 265 | 299 | | 7½ | min 265 | 298 | | 8 | min 265 | 301 | | 8½ | min 265 | 303 | | 3. Palm Width (mm) | | | | Size | | | | 6½ | $83 \pm 6$ | 85 | | 7 | $89 \pm 6$ | 92 | | 7½ | $95 \pm 6$ | 96 | | 8 | $102 \pm 6$ | 104 | | 8½ | $108 \pm 6$ | 110 | | 4. Single Wall Thickness (mm) | | | | Finger | min 0.10 | 0.27 | | Palm | min 0.10 | 0.25 | | Cuff | min 0.10 | 0.20 | | 5. Physical Properties<br>Type 2<br>Before Aging : | | | | Tensile Strength (MPa) | min 17 | 19.62 | | Ultimate Elongation (%) | min 650 | 1108 | | Stress at 500% Elongation (MPa) | max 7.0 | 1.92 | | After Aging : | | | | Tensile Strength (MPa) | min 12 | 16.35 | | Ultimate Elongation (%) | min 490 | 1101 | े ) 0 Page 2 of 3 {2}------------------------------------------------ ## 8. Substantial Equivalence based on Assessment of Non-Clinical Performance Data The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3577-91 Type 2. ### 9. Conclusion g This glove exceeds the ASTM D 3577-91 Type 2 requirements, and also meet FDA requirements for waterleak test on pinhole AQL. Date Summary Prepared : July 16, 1998 Page 3 of 3 1649 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 2 1999 Mr. Yue Wah Chow Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA K982600 Re : Profeel Synthetic Copolymer Surgical Gloves Trade Name: (Powdered) Regulatory Class: I Product Code: KGO January 6, 1999 Dated: Received: January 11, 1999 Dear Mr. Yue Wah Chow: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {4}------------------------------------------------ Page 2 - Mr. Yue Wah Chow through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### ATTACHMENT 2 Applicant : Wembley Rubber Products (M) Sdn. Bhd. | 510(k) Number (if known) : | K982600 | |----------------------------|--------------------------------------------------------| | Device Name : | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) | ### Indications For Use : : - The surgeon's glove is a device made of synthetic copolymer intended to be 1. 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 (Per 21 CFR 801.109) Over-The-Counter Use OR Stward by him Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K982600