POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE

{0}------------------------------------------------ # PT. Shamrock Manufacturing Corpora Jalan Pemuda No. 11, Medan-20151, N. Sumatra – Indonesia Ph. (+62-61) 455 8888 Fax. (+62-61) 452 0588 Email. smc@shamrock-id.com ============================================================================================================================================================================= September 30, 2005 K052709 Page Numbers 1 of 2 ### "510 (K)" SUMMARY | (1) Name of applicant | : RUDI SALIM | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | : PT. SHAMROCK Manufacturing Corpora<br>Jl. Pemuda No. 11 Medan 20151<br>North Sumatra - Indonesia | | Phone No. | : 62-61-4558888 | | Fax No. | : 62-61-4520588 | | Contact person in U.S.A | : Emmy Tjoeng | | Phone No. | : 909-591-855 | | Fax No. | : 909-628-6283 | | (2) Device details | | | Trade Name | : Powder free Latex Examination Gloves | | Classification Name | : Powder free Latex Examination Gloves | | (3) Product Code | : 80 LYY | | (4) Equivalent device legally marketed | : Class I Powder Free Latex Examination Gloves 80 LYY meeting ASTM D 3578-05 | | (5) Intended use | : Powder free Latex Examination gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. | {1}------------------------------------------------ # PT. Shamrock Manufacturing Corpora Jalan Pemuda No. 11, Medan-20151, N. Sumatra – Indonesia Ph. (+62-61) 455 8888 Fax. (+62-61) 452 0588 Email. smc@shamrock-id.com 글쓰레드드르드르드르드스크스트드르드르드로드로드로드로드로드드로드드로드드로드드로드드로드드로드드드드드드드드드드드드 Page Numbers 2 of 2 - (6) Technological characteristic of the gloves. | a. Dimensions<br>Sizes | Small | Medium | Large | X-Large | | |------------------------|-------|--------|-------|---------|---------| | Length mm (min.) | 240 | 240 | 240 | 240 | $\pm$ 5 | | Palm Width mm (min) | 80 | 95 | 100 | 110 | $\pm$ 1 | | Thickness | | | | | | | 1. Cuff mm (min) | 0.1 | 0.1 | 0.1 | 0.1 | | | 2. Palm mm(min) | 0.1 | 0.1 | 0.1 | 0.1 | | | 3. FingerTip mm (min) | 0.1 | 0.1 | 0.1 | 0.1 | | #### b. Physical Properties 2012-02-04 | | Before ageing | After ageing<br>at 70°C 168 hrs. | |---------------------|----------------|----------------------------------| | Tensile Strength | : 18 MPa (min) | 14 Mpa (min) | | Ultimate Elongation | : 650 % (min.) | 500 % (min.) | - (7) Performance data is the same as mentioned immediately above. - (8) Clinical data is not needed for gloves or for most devices cleared by the 510 (K) process. - (9) Non-clinical data We certify that our final finished powder free latex examination gloves meet or exceed the ASTM D 3578-05 Standard. Meets FDA pin hole requirement. Meets labeling claim. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle-like emblem with three stylized lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. Public Health Service NOV - 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 PT. Shamrock Manufacturing Corporation C/O Ms. Emmy Tjoeng Official Correspondent Shamrock Marketing Company, Incorporated 5445 Daniels Street Chino, California 91710 Re: K052709 Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LLY Dated: November 2, 2005 Received: November 2, 2005 Dear Ms. Tjoeng: 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 - Ms. Tjoeng 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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, C. Lin, Ph.D. 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 {4}------------------------------------------------ ### INDICATION FOR USE : PT. Shamrock Manufacturing Corpora Applicant 510(k) Number (if known): : Powder Free Latex Examination Gloves Device Name : Indication for use A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shuley M. Humphrey D. "0/05 n Sim-Cff) of Anasthesiology, General Hospital, on Control, Dental Devices Number. K252709