NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

{0}------------------------------------------------ ## JUN =8 2004 SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. Yan Li River Bridge East, Che Xing Highway, Che Dun Town, SongHang County, Shanghai, 201611, PRC TEL: 08 21 5760-9473 FAX: 86 21 5760-9245 E-mail: shaforemost@online.sh.cn ## 510 (k) Summary ## 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 - Charyos Sincharoenkul (General Manager) 5. Contract Person: - 6. Date summary prepared: December 10, 2002 - 7. Official Correspondent: Sempermed USA Inc. - 30798 US Hwy. 19N 8. Address: - Palm Harbor, USA , FL 34684 - 727 787 7250 9. Phone: - 727 787 7558 10. Fax: - 11. Contact person: Mr. William E Harris - 12. Device Trade or Proprietary Name: Powder free Viryl 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 880.6250, Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 Ed - 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 panent and examiner - 18. Safety and effectiveness of the device: This device is safe and effective as the predicate device Shanghal Foremost Vinyl Patient Examination Glove, Powder free, Indeed, it is equivalent This is better expressed in the tabulated comparison (Paragraph 19 below) Page 3. 1 {1}------------------------------------------------ - 19. Summary comparing technological characteristics with other predicate device: General comparison result between Powder free Vinyl Examination and predicate device (Shanghai Foremost Vinyl Putient 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<br>CHARACTERISTICS | Comparison result<br>REFER TO ADDITIONAL TECHNICAL<br>COMPARATIVE TABLE WITHIN 510K<br>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) | Page 3.2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human profiles. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN -8 2004 Shanghai Foremost Plastic Industrial Co., Ltd. C/O Mr. Ned Devine Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548-1289 Re: K041041 Ko-1041 Trade/Device Name: Non-Sterile Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: May 26, 2004 Received: May 28, 2004 Dear Mr. Devine: We have reviewed your Section 510(k) premarket notification of intent to market the device we nate 10 row 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 Interstate commerce privers that have been reclassified in accordance with the provisions of Amendments, or to do roomsond Act (Act) that do not require approval of a premarket the Federal F 000; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions over 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 (1 Wri), it may be back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear over way publish further announcements concerning your device in the Eederal Register. {3}------------------------------------------------ Page 2 - Mr. Devine Please be advised that FDA's issuance of a substantial equivalence determination does not I total be act room a determination that your device complies with other requirements nioan that 1271 has music statutes and regulations administered by other Federal agencies. or the ret comply with all the Act's requirements, including, but not limited to: registration r od intist compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and noting (2 = 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 promative next are 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), nlease 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, 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 US Applicant: KO41041 510(k) Number: Device Name: Non Sterile Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves 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 evan miner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kein Mulvey (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K04104 Page 1 of