POWDER FREE VINYL EXAMINATION GLOVE

{0}------------------------------------------------ SHANGHAL FOREMOST PLASTIC INDUSTRIAL CO., LTD. Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai, 201611, PRC TEL: 86 21 5760-9473 FAX: 86 21 5760-9245 E-mail: shaforemost@online.sh.cn ## OCT 1 0 2003 ## 510 (k) Summary Ko 32071 ## As Required by 21 section 807.92 ( c) - 1. Submitter Name: Shanghai Foremost Plastic Industrial Co. ,Ltd. - 2. Address: Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai,201611, PRC - 3. Phone: (+86) 21 5760-9473 - 4. Fax: (+86) 21 5760-9245 - Chaiyos Sincharoenkul (General Manager) 5. Contract Person: - 6. Date summary prepared: December 10, 2002 - 7. Official Correspondent: Sempermed USA Inc. - 30798 US Hwv. 19N 8. Address: - Palm Harbor, USA , FL 34684 - 9. Phone: 727 787 7250 - 10. Fax: 727 787 7558 - 11. Contact person: Mr. William E Harris - 12. Device Trade or Proprietary Name: Powder free Vinyl Examination - 13. Device Common or usual name: Examination glove - 14. Device Classification Name: Glove , Patient Examination , Vinyl - 15. Substantial Equivalency is claimed against the following device : Shanghai Foremost Vinyl Patient Examination Glove, Powder free, 510(k) #k971415 (refer to Appendix 1 for FDA website printout) This notification for the Powder free Vinyl Examination glove is of the ABBREVIATED type as per the declaration of conformity on page B2 of this summary - 16. Description of the Device: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 380,6250. Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 E4 - 17. Intended use of the device: This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner - 18. Safety and effectiveness of the device: This device is safe and effective as the predicate device Shanghai Foremost Vinyl Patient Examination Glove, Powder free, Indeed, it is equivalent This is better expressed in the tabulated comparison (Paragraph 19 below) Image /page/0/Picture/31 description: The image displays the word "CONFIDENTIAL" in bold, uppercase letters. The font appears to be a sans-serif typeface, and the letters are closely spaced. The image has a slightly grainy texture, suggesting it may be a scan or a copy of an original document. {1}------------------------------------------------ - 19. Summary comparing technological characteristics with other predicate device: General comparison result between Powder free Vinyl Examination and predicate device (Shanghai Foremost Vinyl Patient Examination Glove, Powder free) is tabulated below. Technical comparison of specific elements is attached in the main submission. | FDA file reference number | 510k Number: K971415 | |--------------------------------------------------|------------------------------------------------------------------------| | Attachments inside notification submission file | REFER TO APPENDIX 1 | | TECHNOLOGICAL CHARACTERISTICS | Comparison result | | | REFER TO ADDITIONAL TECHNICAL COMPARATIVE TABLE WITHIN 510K SUBMISSION | | Indications for use | Identical | | Target population | Identical | | Design | Similar | | Materials | Similar | | Performance | Identical | | Sterility | Identical | | Biocompatibility | Identical | | Mechanical safety | Identical | | Chemical safety | Identical | | Anatomical sites | Identical | | Human factors | Identical | | Energy used and/or delivered | Identical (Not applicable) | | Compatibility with environment and other devices | Identical | | Where used | Identical | | Standards met | Identical | | Electrical safety | Identical (not applicable) | | Thermal safety | Identical (not applicable) | | Radiation safety | Identical (not applicable) | Image /page/1/Picture/5 description: The image contains the word "CONFIDENTIAL" in bold, black letters. The word is slightly tilted upwards from left to right. The background is white, providing a strong contrast to the text. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circle with the words "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 1 0 2003 Shanghai Foremost Plastic Industrial Co., Ltd C/O Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548 Re: K032071 Trade/Device Name: Powder Free Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 6, 2003 Received: October 8, 2003 Dear Mr. Devine: 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. Devine 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, Quris 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}------------------------------------------------ SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. Yan Li River Bridge East, Che Xing Highway, Che Dun Town, Songjiang County, Shanghai, 201611, PRC TEL: 86 21 5760-9473 FAX: 86 21 5760-9245 E-mail: shaforemost@online sh.cn ## INDICATIONS FOR USE Applicant: Shanghai Foremost Plastic Industrial Co. ,Ltd. 622071 510(k) Number: Device Name: Powder free Vinyl Examination Glove Indications for Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. Oat Ang. de Onn. 10/10/03 (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device 510(k) Number:________________________________________________________________________________________________________________________________________________________________ R 032071 Page C3