LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date July 12, 1999. The date is written in a simple, sans-serif font. To the left of the date is a small, stylized image of a flower or starburst. The image is black and white and appears to be a scan or photocopy. ## JANNA TUCKER & ASSOCIATES 510(k) SUMMAR Y RY K992031 198 Avenue De La D'emerald Sparks, NV 89434-9550 Ph: 775-342-2612 Fax: 775-342-2613 | Submitted By: | Janna Tucker & Associates | |---------------|----------------------------| | | 198 Avenue de la D'emerald | | | Sparks, NV 89343 | | Phone: | 775-342-2612 | | FAX: | 775-342-2613 | Contact Person: Janna P. Tucker, Official Correspondent for Shanghai Changzheng Latex Factory Date of Submission: 7 June 1999 Patient Examination Glove Device Name: (Multiple Labels) Exam Gloves, Latex, Powder-Free, with Proprietary Name: Protein Labeling. Labels/Labeling: This device will be marketed to healthcare professionals at dentist, and doctor offices, laboratories, clinics and hospitals through its intended use. A patient examination glove is a disposable device intended for Intended Use: medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Substantial Equivalence: This device is equivalent to those in commercial distribution. They are to be worn as a protective device on the examiner's hand or finger. Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is substantially equivalent to the device manufactured bv Evergrade Healthcare Products SDN BHD, K973664, Latex Examination Glove, Powder-Free, with Protein Content Labeling Claim. IBIT M 47 of 48 {1}------------------------------------------------ ## Test Results (Means and/or Results): This device has met or exceeded the following standards/tests: ASTM D ASTM D 3758-95 ASTM D 5151 FDA Water Leak Test (before & after aging) Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bacteria Mold Conclusions: This device is substantially equivalent to the device approved as K973664. EXHIBIT M Page 48 of 48 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1.2 1999 Shanghai Changzheng Latex Factory c/o Janna Tucker & Associates Ms. Janna P. Tucker Official Correspondent 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550 Re : K992031 Trade Name: Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein) Requlatory Class: T Product Code: LYY Dated: June 14, 1999 Received: June 16, 1999 Dear Ms. Tucker: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. {3}------------------------------------------------ Page 2 - Ms. Tucker this response to your premarket notification Please note: submission does not affect any obligation you might have under bubmisbled. acob ough 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA ating of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markees problems, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation 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 ene regulation cherocod, "Alberting of "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ser Timothy A Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Junier Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE Nato APPLICANT દેશના SHANGHAI CHANGZHENG LATEX FACTORY K992031 210(K) NUMBER : 一年十六年 ಿ DEVICE NAME: amination ( 685 WATER SOLUBLE PROTECT A A patient examination glove is a disposable device intended for medical purposes that is t and the country and and and assessed contemination between patient and A patient examination glove is a disposable device is as as as as as as a continue examiner. (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) OR Over-The-Counter Use X (Optional Format 1-2-96) Chin S. Lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K992031 EXHIBIT B Page 2 of 48