POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for PT. Shamrock Manufacturing Corporation. The logo consists of a shamrock with the letters SMC inside of it. The text "PT. Shamrock Manufacturing Corporation" is to the right of the shamrock. Image /page/0/Picture/1 description: The image shows four different certification logos. The first logo is the TUV Rheinland Product Safety certification, which features a triangle above the text. The second logo is a medical device certification. The third logo is the TUV CERT DIN EN ISO 9002 certification, with the certificate number 01 100 006971. The fourth logo is the CE marking, which indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. MAR 2 8 2003 K030386 Page Numbers 1 of 2 P ### "510 (K)" SUMMARY (1) Name of applicant Address : DR. SUPENO SURYA, MBA PhD : SHAMROCK Manufacturing Corp. Jl. Pemuda No. 11 Medan North Sumatra - Indonesia Phone No. : 62-61-4558888 Fax No. : 62-61-4520588 Contact person in U.S.A : Emmy Tjoeng Fax No. : 909-591-8878 - (2) Device details Trade Name : Powder free Synthetic Nitrile Neoprene Examination Gloves : Powder free Synthetic Nitrile Neoprene Examination Gloves Classification Name - (3) Product Code : 80 LZA - (4) Equivalent device legally marketed : Class I Examination Gloves 80 LZA meeting ASTM D 6319-00 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with a four-leaf clover in the center. The letters "SMC" are written across the clover. The logo is enclosed in a circle. # r. Shamrock Image /page/1/Picture/2 description: The image contains four different certification logos. The first logo is a triangle with the text "TUV Rheinland Product Safety" below it. The second logo contains the letters "GN" with a medical symbol. The third logo is a "TUV CERT" logo with the text "DIN EN ISO 9002 Certificate 01 100 008971" below it. The fourth logo contains the letters "CE". Page Numbers 2 of 2 - (5) Intended use : Powder free Synthetic Nitrile Neoprene Examination Gloves disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. #### (6) Technological characteristic of the gloves. | a. Dimensions<br>Sizes | Small | Medium | Large | X-Large | |------------------------|-----------|----------------|------------|----------------------------------| | Length mm (min.) | 240 | 240 | 240 | 240 | | Palm Width mm | $80\pm10$ | $95\pm10$ | $111\pm10$ | $\ge 110$ | | Thickness | | | | | | 1. Cuff mm (min) | 0.10 | 0.10 | 0.10 | 0.10 | | 2. Palm mm(min) | 0.10 | 0.10 | 0.10 | 0.10 | | 3. Finger Tip mm | 0.10 | 0.10 | 0.10 | 0.10 | | b. Physical Properties | | | | | | | | Before ageing | | After ageing<br>at 70°C 168 hrs. | | Tensile Strength | | : 21 Mpa (min) | | : 14 Mpa (min) | | Ultimate Elongation | | : 700 % (min.) | | : 500 % (min.) | (7) Performance data is the same as mentioned immediately above. - (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process. - (9) Non-clinical data We certify that the gloves meet or exceed the ASTM D 6319-00 Standard. Meets FDA pinhole requirement. Meets labeling claim. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "HUMAN SERVICES • USA" is arranged in a circular fashion above the bird, and the word "DEPARTM." is placed below the bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### MAR 2 8 2003 PT. Shamrock Manufacturing Corporation C/O Ms. Emmy Tjoeng Shamrock Manufacturing Company, Incorporated 5445 Daniels Street Chino, California 91710 Re: K030386 Trade/Device Name: Powder Free Synthetic Nitrile Neoprene Examination Gloves, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: February 4, 2003 Received: February 5, 2003 Dear Ms. Tjeong: 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. Tjeong 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 (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 Puno 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 is a black and white logo. The logo is a circle with the letters "SMC" in bold, white font. Behind the letters is a four-leaf clover. The clover is black and fills the majority of the circle. ## T. Shamrock Manufacturing Image /page/4/Picture/2 description: The image contains three logos. The first logo is a triangle with the text "TUV Rheinland Product Safety" underneath. The second logo has the letters "GN" with a medical symbol in the middle and the text "Approved medical device" underneath. The third logo has the text "TUV CERT DIN EN ISO 9002 Certificate 01 100 000971". Image /page/4/Picture/3 description: The image contains a CE marking, which is a symbol used to indicate that a product conforms to health, safety, and environmental protection standards for products sold within the European Economic Area. The marking consists of the letters 'C' and 'E' in a specific form. The CE marking is a declaration by the manufacturer that the product meets all the relevant provisions of the applicable directives. #### ANNEXURE II ### INDICATION FOR USE Applicant : DR. SUPENO SURYA, MBA PHD Device Name : Powder free Synthetic Nitrile Neoprene Examination Gloves, Green () of of Indication for use .. Powder free Synthetic Nitrile Neoprene Examination Gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contaction between patient and examiner. (Signature) DR. SUPENO SURYA, MBA PhD (Type Name) Feb 03. 2003 (Date) Qian S. Lin (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Division of Anesthesiology, General Devices Infection Control, Dental D 510(k) Number: K03086