PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)

{0}------------------------------------------------ WRP Asia Pacific Sdn Bhd JUL 2 4 2002 Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA # 510(k) SUMMARY K021784 +60-3-8706 1486 TEL +60-3-8706 1485 FAX cyw wrp@wrpworld.com www.wrpworld.com ## 1.0 Submitter: | Name: | WRP Asia Pacific Sdn Bhd | |------------|--------------------------------------------------------------------------------------------------------------| | Address: | Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak<br>Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | 27 MAY 2002 Date of Summary Prepared: ## 2.0 Contact Person: | Name: | Mr. Yue Wah, CHOW | |------------|-------------------| | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | #### 3.0 Name of the device: | Trade Name: | 1. Profeel<br>2. Multiple or Customer's Trade Name | |----------------------|--------------------------------------------------------------------------------------------| | Device Name: | Powder Free Polymer Coated Brown Latex Surgical Gloves<br>Sterile (Protein Labeling Claim) | | 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 - 0181 Type 1 and FDA 21 CFR 800.20. ### 5.0 Description of The Device: The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577-0151 and FDA 21 CFR 800.20. Com {1}------------------------------------------------ # WRP Asia Pacific Sdn Bhd 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 ## Intended Use of the Device: 6.0 The Powder Free Polymer Coated Brown Latex Surgical Glove, Sterile (Protein Labeling Claim) 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, ## Summary of The Technological Characteristics of The Device: 7.0 The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |-----------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Dimensions | ASTM D 3577 - 01E1 | Meets | | Physical Properties | ASTM D 3577 - 01E1 | Meets | | Freedom from pinholes | ASTM D 3577 - 01E1<br>FDA 21 CFR 800.20 | Meets | | Powder-Free | ASTM D 6124 - 01 | Meets<br>2 mg/glove maximum | | Protein Level | ASTM D 5712 – 95 | < 50 µg/g | | Biocompatability | Primary Skin Irritation in<br>Rabbits<br><br>Dermal Sensitization | Passes<br>(Not a primary skin irritant)<br><br>Passes<br>(Not a contact sensitizer) | Page 2 of 3 {2}------------------------------------------------ Image /page/2/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 hexagon. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar font. The text is black and appears to be printed on a white background. #### Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0 The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above. #### 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. #### 10.0 Conclusion It can be concluded that the Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requiremnts for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices. {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 a stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a more standard font. Below the company name is the number 147817V. # INDICATIONS FOR USE Applicant: WRP Asia Pacific Sdn Bhd 510(k) Number (if known): K021784 Device Name: POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) Indications For Use: The surgeon's 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) Prescription Use OR Over-The-Counter ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. (Per 21 CFR 801.109) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing right, with three parallel lines above them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUL 2 4 2002 Mr. Yue Wah Chow Head of Department QA/RA Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA Re: K021784 Trade/Device Name: Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) 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: May 27, 2002 Received: May 30, 2002 Dear Mr. Chow: 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. {5}------------------------------------------------ Page 2 - Mr. Chow 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.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timoth A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ Image /page/6/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, with the letters arranged in a slightly overlapping fashion. To the right of the letters is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "1 4 7 8 1 7 V". # INDICATIONS FOR USE | Applicant: | WRP Asia Pacific Sdn Bhd | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known): | K021784 | | Device Name: | POWDER FREE POLYMER COATED BROWN<br>LATEX SURGICAL GLOVES, STERILE<br>(PROTEIN LABELING CLAIM) Contains 50mcgr<br>or less of Total Water Extractable protein<br>per gram. | | Indications For Use: | | The surgeon's 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) OR Prescription Use (Per 21 CFR 801.109) .............................................................................................................................................................................. Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ Saruta by Clin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ___________________________________________________________________________________________________________________________________ Page 1 of 1 Vour Dartnar In Drotoction™