LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES

{0}------------------------------------------------ Kg84147 (Company No. 52031-D) Lot 8, Jalan Suasa, 42500 Telok Panglima Garang, Kuala Langat, Selangor Darul Ehsan, Malaysia. Tel: 603-3526711 Fax: 603-3527733 JAN 20 1999 ### 510 (k) SUMMARY #### 1. Submission Applicant Name: Street Address: _ Lot 8, Jalan Suasa ,42500 Telok Panglima Garang , Country Malaysia Selangor Darul Ehssn Phone No _ + 6-03-352 7402 FAX No +6-03-352 7733 Contact Person: M.G. Desai 8040475 A 444401 [Registration Number, Form 2891(a)] (Device Listing Number, Form 2892) Activity: [ X ] Manufacturer Applicant Lovytex Sdn Bhd K 98 4147 ★ 510(k) Number (if known): __ #### 2. Device Particulars Device Name: Powder-free Polymer Coated Latex Examination Gloves with protein label claim 50 micro-grams per gram Trade/Proprietary Name: N/A Common Name: Powder-free Examination Gloves Classification Name: Patient Examination Gloves {1}------------------------------------------------ ### 3. Device Classification Device Class: Class 1 Product Code: Latex (Powder-free). 80LYY ## 4. Device Description Product Code: Latex (Powder-free). 80LYY Device Class: Class 1 ### 5. Summary of Intended Use A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient. #### 6. Summary of Technological Characteristics | Characteristic | Reference Document | Device Performance | |---------------------------|--------------------|---------------------| | Water Leak | ASTM D 3578/FDA | Meets or Exceeds | | Residual Powder | ASTM D 6124 | Meets or Exceeds | | Tensile | | | | - Unaqed | ASTM D 3578-95 | Meets or Exceeds | | - Aged | ASTM D 3578-95 | Meets or Exceeds | | Elongation @ Break | | | | - Unaged | ASTM D 3578-95 | Meets or Exceeds | | - Aged | ASTM D 3578-95 | Meets or Exceeds | | Water Extractable Protein | ASTM D 5712-95 | 50 u grams per gram | {2}------------------------------------------------ L984147 ### 7. Assessment of Non-Clinical Performance Data The device :- - meets or ecxeeds the ASTM standard or equivalent standard - meets FDA pinhole requirements; and - meets the labelling claim as shown by the data in Section 6 above. #### 8. Assessment of Biocompatibility Performance Data SUMMARY OF RESULTS OF BIOCOMPATIBILITY TESTS CYTOTOXICITY RABBIT SKIN IRRITATION -MEM test extract was NON-TOXIC at dilution 1:8 at 24 hours.. - PASSES GUINEA SENSITIZATION STUDY - PASSES {3}------------------------------------------------ K984147 # 9. CONCLUSIONS OF NON-CLINICAL & BIOCOMPATIBILITY PERFORMANCE DATA The device has been carefully compared to existing performance criteria of the ASTM and FDA to which all legally marketed devices are required to be compared. The data summaries indicate that the proposed device meets or exceeds all acceptable scores and satisfies all requirements for powder-free natural latex examination gloves. Pursuant to 21 CFR 807.87 (j), I M.G. Desai, the Chief Executive Officer of Lovytex Sdn Bhd, certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Chief Executive Officer of Lovytex Sdn Bhd, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission. ti (Signature) M. G. Desai (Typed Name) 11-16-98 (Dated) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 20 1999 Mr. M.G. Desai Chief Executive Officer Lovytex Sdn. Bhd. (Company No. 52031-D) Lot #8, Jalan Suasa 42500 Telok Panglima Garang, Kuala Langat, Selangor Darul Ehsan, MALAYSIA Re : K984147 Lovytex Powder-Free Polymer Coated Latex Trade Name: Examination Glove with Protein Content of Labeling Claim (50 micrograms or less) Requlatory Class: I Product Code: LYY November 16, 1998 Dated: November 19, 1998 Received: Dear Mr. Desai: 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 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). 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 reqistration, 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 regulations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: {5}------------------------------------------------ Page 2 - Mr. Desai this response to your premarket notification submission does chis response to your promon might have under sections 531 through 542 of the Act for devices under the Electronic enrough Sri or on Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in four and equivalence of your device to a legally marketed predicate device results in a classification for your marrice and thus, 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 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 807.97). Other qeneral 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/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Directpr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### 3.0 Indication For Use #### INDICATION FOR USE Applicant : Lovytex Sdn Bhd 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Powder-free Polymer Coated Latex Examination Gloves with protein label claim 50 micro-grams per gram. Indication For Use: 1 : ......... . ﺎ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 대표 - 1000 ، ، - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - . · . A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter X Per 21 CFR 801.109 (optional Format 1-2-96) Olin Silon Division Sign-Off) Division of Dental, Infestiga Comfrol; and General Hospital Devices 510(k) Number CONFIDENTIAL- DO NOT COPY