DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR

{0}------------------------------------------------ # JUL 6 - 2005 510(K) SUMMARY This summary of 510(K) safety and effectiveness information is being submitted in Accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(K) number is: ### 1. Submitter's Identification: Mr. Nick Bien Ever Global Enterprise Corporation Long Thanh Industrial Zone Taman Village, Long Thanh District Dong Nai Province, Vietnam Date Summary Prepared: April 15, 2005 ### 2. Name of the Device: Ever Global Enterprise Corporation Disposable Powdered Vinyl Exam Glove Yellow Color ### 3. Predicate Device Information: Assured Medical Supply Company, Ltd. Vinyl Examination Glove (K932054) ### 4. Device description: Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ., and meets all requirements of ASTM Standard D5250-00E4. ### 5. Intended Use: 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. {1}------------------------------------------------ ## 6.Comparison to Predicate Devices: Ever Global Enterprise Corporation's Disposable Powdered Vinyl Exam Glove, Yellow Color is substantially equivalent to the device manufactured by Assured Medical Supply Company, Ltd. (K932054) except for the yellow color additive being added to this glove. # 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows: The standards used for Ever Global Enterprise Corporation's glove production are Based on ASTM D5250-00E4. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0. The FDA 1000 ml Watertight Test based on ASTM D-5151-99 was also conducted with samplings of AQL 2.5, Inspection level I, mecting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions. There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels. ## 8. Discussion of Clinic Tests Performed: Not applicable - There is no Hypoallergenic Claim. #### 9. Conclusions: Ever Global Enterprise Corporation's Disposable Powdered Vinyl Exam Glove, Yellow Color conform fully to ASTM D-5250-00E4 standard as well as applicable 21CFR references, and, mects pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 6 - 2005 Mr. Nick Bien Manager Ever Global Enterprise Corporation Long Thanh Industrial Zone Taman Village, Long Thanh District Dong Nai Province, VIETNAM Re: K051498 Trade/Device Name: Disposable Powdered Vinyl Exam Glove Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: April 15, 2005 Received: June 7, 2005 Dear Mr. Bein: 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. Bien 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 mount that I Dr may Federal statutes and regulations administered by other Federal agencies. or the Fee or any 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 and iboms (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelies 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) I mis letter will and in J . 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), n you desire specifica of Compliance at (240) 276-0115. 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 may overn 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/industry/support/index.html. Sincerely yours, Chau-Lin, Ph.D. 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}------------------------------------------------ # Indications for Use # Applicant: EVER GLOBAL ENTERPRISE CORPORATION 510(k) Number (if known): __ L = 57498 Device Name: Disposable Powdered Vinyl Exam Glove Yellow Color Indications for Use: A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION between patient and EXAMINER. Prescription Use __ AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use __ X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) 4 Concurrence of CDRH, Office of Device Evaluation (ODE) 6 Shirl A. Murphy 7/15/05 esthesiology, General Hospital, ontrol Denta 510(k) Number: K05145