POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE

{0}------------------------------------------------ Ko23762 | 510(k) SUMMARY | | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted For: | NINGBO TIANSHUN RUBBER PRODUCTS<br>CO., LTD. | | Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for NINGBO TIANSHUN ETC.<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>Phone:<br>775-342-2612<br>Fax:<br>775-342-2613<br>E-Mail:<br>Tuckerjan@aol.com | | Date of Submission: | 30 October 2002 | | Device Name: | POWDER-FREE NITRILE EXAM GLOVES,<br>COLOR: BLUE<br>Class I Device, 80LZA | | Proprietary Name: | (Multiple Private Labels) | | Labels/Labeling: | This device will be marketed to healthcare professionals at<br>Dentist and Doctor Offices, Laboratories, Clinics and<br>Hospitals through its distributors for the intended use. | | Intended Use: | A patient examination glove is a disposable device intended<br>for medical purposes that is worn on the examiner's hand<br>or finger to prevent contamination between patient and<br>examiner. | | Substantial Equivalence: | Both in its intended use and/or physical<br>characteristics, this device is equivalent to devices<br>currently marketed by U.S. companies. It is Substantially<br>Equivalent to the gloves manufactured by Ningbo Yujiang<br>Plastic & Rubber Co., Ltd. (K011286) and Shasta Asia<br>Partners Gloves Mfg Co., Ltd. (K000670). | EXHIBIT N Page 44 of 45 {1}------------------------------------------------ 510k) Summary page 2. Test Results (Means and/or Successful Results: This device has met or exceeded the following standards and/or tests: ASTM D 6124-01 ASTM D 6319-00aE3 ASTM D 5151-99 ISO 2859 MIL Std 105E Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Bio-Burden (Procedure Method 8315) Conclusion: This device is substantially equivalent to the devices approved as K011286 and K000670. EXHIBIT N Page 45 of 45 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### 1 8 200 Ningbo Tianshun Rubber Products Company Limi C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550 Re: K023702 Trade/Device Name: Powder-Free Nitrile Examination Gloves, Color: Blud Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: October 30, 2002 Received: November 1, 2002 Dear Ms. Tucker: 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 vour 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. Tucker 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 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Runner Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {4}------------------------------------------------ ### INDICATIONS FOR US # APPLICANT: # NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD ## 510(k) NUMBER: # DEVICE NAME: ### POWDER FREE NITRILE EXAM GLOVES, COLOR: BLUE A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. K023702 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) EXHIBIT B Page 2 of 45 OR Over-The-Counter Use_ (Optional Format 1-2-96) (Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices 510(k) Number. K023702