CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN)

{0}------------------------------------------------ # NOV 17 1999 ### SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 ~ 322 3200, Fax : 605 ~ 322 2300 | | K993134 Attachment M | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | | SMDA 510 (K) SUMMARY | | 1.0 | | | 2.0 Submitter | SEAL POLYMER INDUSTRIES SDN BHD<br>Lot 72706, Jalan Lahat<br>Kawasan Perindustrian Bukit Merah<br>31500 Lahat, Perak, Malaysia | | Tel | (60 5) 322 3200 | | Fax | (60 5) 322 2300 | | Name of Contact Person | Mr. CHAN CHIN HONG | | Date of Summary Prepared | September 4, 1999 | | 3.0 Name of Device | | | Trade Name | Cashmere Non-Sterile, Powder Free Nitrile<br>Examination Gloves (Blue)<br>Cashmere Non-Sterile, Powder Free Nitrile<br>Examination Gloves (Green) | | Common Name | Exam Glove | | Classification Name | Nitrile Patient Examination Glove | #### 4.0 Identification of The Legally Marketed Devices Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements. #### 5.0 Description of The Device Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test. #### 6.0 The Intended Use of Glove A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. {1}------------------------------------------------ SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300 Attachment M #### 7. Summary of Performance Data : Performance data of gloves based on ASTM D3578-95 and FDA 1000 ml watertight test. | TEST | ASTM D3578-95 | CASHMERE POWDER FREE NITRILE EXAM GLOVES | |----------------------------------------|----------------|------------------------------------------| | 1. Watertight (1000 ml) | GI<br>AQL=4.0% | Pass GI<br>AQL=4.0% | | 2. Length (mm)<br>Size XS | Min 230 | 240 mm minimum for all sizes | | S | Min 230 | | | M | Min 230 | | | L | Min 230 | | | XL | Min 230 | | | 3. Palm width (mm)<br>Size XS | - | 75 - 78 | | S | 80 +/- 10 | 82 - 88 | | M | 95 +/- 10 | 92 - 98 | | L | 111 +/- 10 | 102 - 108 | | XL | - | 111-115 | | 4. Thickness (mm) (Single Layer) | | | | Finger | Min 0.08 | 0.10 minimum | | Palm | Min 0.08 | 0.10 minimum | | 5. Physical Properties<br>Before Aging | | | | Tensile Strength (Mpa) | Min 14 | 16.5 | | Ultimate Elongation (%) | Min 500 | 550 | | After Aging | | | | Tensile Strength (Mpa) | Min 14 | 23.1 | | Ultimate Elongation (%) | Min 500 | 520 | | 6. Powder Content | - | Below 2 mg / glove | Page 2 of 3 {2}------------------------------------------------ SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300 Attachment M - 8. The performance data of the glove as shown above meet the ASTM D3578-95 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. - 9. The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test. The gloves pass the Biocompatibility Tests. - 10. Conclusion We concluded that the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue) and Gashmere Non-Sterile, Powder Free Nitrite Examination Gloves (Green) meet : - = ASTM D3578-95 Standard - FDA pinhole requirements - ・ FDA minimum powder residual content Page 3 of 3 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with three curved lines representing its wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 17 1999 Mr. Chan Chin Hong General Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia Re : K993134 Cashmere Non-Sterile Blue Powdered Nitrile Trade Name: Examination Gloves Requlatory Class: I Product Code: LZA Dated: October 23, 1999 Received: October 28, 1999 Dear Mr. Hong: 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any {4}------------------------------------------------ Page 2 - Mr. Hong obligation you might have under sections 531 through 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 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 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 ene regaracton cheroids, "NEWS andalig 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, Hy A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {5}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT : Seal Polymer Industries Sdn. Bhd. Applicant K993134 510(K) Number : : Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue) Device Name Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Green) Indication For Use: This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment. .............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC) Prescription Use: ... ... ... ... ... ... .. .. . Per 21 CFR 80.109 OR Over-The-Counter........\X........ Olim S. hin (Division Sign-Off) Division of Dental, Infection Con and General Hospita F 1 (k) Number .