GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the letters "WRP" in white against a black, rounded hexagonal background. The letters are bold and sans-serif, with the "W" being the widest and the "P" being the narrowest. The logo has a slightly distressed or textured appearance, giving it a vintage or worn look. The overall design is simple and eye-catching. PT. WRP Buana Multicorpora Image /page/0/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is "KO32011". The writing is in black ink on a white background. The text is slightly tilted. Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA | Tel | +62-61-6942461<br>+62-61-6942462 | |-----|----------------------------------| | Fax | +62-61-6942463 | | URL | www.wrpworld.com | :" i 1.1 ... (1) # 510 (K) SUMMARY ## AUG 1 9 2003 #### 1.0 Submitter : | Name | : PT. WRP Buana Multicorpora | |-----------|---------------------------------------------------------------------------| | Address | : Jl. Jermal No.20B Kelurahan Sei Mati<br>Medan Labuhan KM 17, INDONESIA. | | Phone No. | : +61 6942461, 6942462 | | Fax No. | : +61 6942463 | Date of Summary Prepared : 29 July , 2003 #### 2.0 Contact Person : | Name | : Mr. Ng Poy Sin | |-----------|------------------------| | Phone No. | : +61 6942461, 6942462 | | Fax No. | : +61 6942463 | #### 3.0 Name of the device : | Trade Name | 1). Glovetex, and | |---------------------|-----------------------------------------------------------| | | 2). Multiple or Customers' Trade Name | | Device Name | Powder Free White Nitrile Examination Gloves, Non-Sterile | | Common Name | Examination Gloves | | Classification Name | Patient Examination Gloves (Class I) | #### 4.0 ldentification of The Legally Marketed Device : Class I patient examination gloves, 80LZA, powder free, that meets all the requirements of ASTM standard D 6319 -- 00a83 and FDA 1000 ml Water Leak Test. #### 5.0 Description of The Device : The Powder Free White Nitrile Examination Gloves, Non sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test. #### 6.0 Intended Use of the Device : The Powder Free White Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. \$\kappa5\overline{3}\$ Page 1 of 2 Your Partner In Protection™ {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is that of a company name or title, presented in a straightforward and professional manner. Image /page/1/Picture/1 description: The image shows a handwritten text that appears to be a signature or code. The text includes the letters 'Ko' followed by the numbers '32011'. The text is written in black ink on a white background and has a slightly tilted orientation. Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA +62-61-6942461 Tel +62-61-6942462 Fax +62-61-6942463 www.wrpworld.com URL #### Summary of The Technological Characteristics of The Device : 7.0 The Powder Free White Nitrile Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards. | CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE | |-----------------------|---------------------------------------|----------------------------------------| | Dimensions | D 6319 – 00ae3 | Meets | | Physical Properties | D 6319 - 00ae3 | Meets | | Freedom from Pinholes | D 6319 - 00ae3<br>FDA 21 CFR 800.20 | Meets | | Powder Free Residue | D 6124 - 01 | Meets<br>< 2 mg/glove | | Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes<br>(No primary skin irritation) | | | Dermal Sensitization | Passes<br>(No contact sensitizer) | #### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The performance test data of the non-clinical tests that support a determination of substantial equivalent 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 White Nitrile Examination Gloves, Non Sterile will perform according to the glove performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. Public Health Service AUG 1 9 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 PT. WRP Buana Multicorpora Mr. Ng Poy Sin President Director Jalan Jermal No. 20-B, Kelurahan Sei Mati Medan- Labuhan Km 17, INDONESIA Re: K032011 Trade/Device Name: Powder Free White Nitrile Examination Gloves, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 30, 2003 Received: August 4, 2003 Dear Mr. Sin: 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. Sin 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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Runne Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for PT. WRP Buana Multicorpora. The logo consists of the letters "WRP" in a stylized font inside of a dark oval shape. To the right of the logo is the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font. Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA Tel + 62-61-6942461 +62-61-6942462 Fax +62-61-6942463 URL www.wrpworld.com ## INDICATIONS FOR USE | Applicant | : PT. WRP Buana Multicorpora | |--------------------------|---------------------------------------------------------------| | 510(k) Number (if known) | : K032011 | | Device Name | : POWDER FREE WHITE NITRILE EXAMINATION<br>GLOVES NON STERILE | Indications For Use: Powder Free White Nitrile Examination Gloves, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Concurrence of CDRH, Office of Device Evaluation (ODE) Olin S. him (Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K032011 Prescription Use OR Over-The-Counter (Per 21 CFR 801.109)