CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED)

{0}------------------------------------------------ # SEP 2 6 2002 SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my K022792 | 1.0 | <b>SMDA 510 (K) SUMMARY</b> | |-----|-----------------------------| |-----|-----------------------------| | 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 | Ms. CHUN CHOOI FONG | | | Date of Summary Prepared | August 8, 2002 | | 3.0 | <b>Name of Device</b> | | |-----|-----------------------|------------------------------------------------------------------------| | | Trade Name | Cashmere Powder Free Latex Examination Gloves E protein labeling claim | Exam Glove Patient Examination Glove Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the Identification of The Legally Marketed Devices requirements of ASTM Standard D3578-01 and FDA requirements. Common Name 4.0 Classification Name ### 5.0 Description of The Device Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water Leak Test. #### The Intended Use of Glove 6.0 A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. > Page 1 of 3 ATTACHMENT M {1}------------------------------------------------ ## SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my ### 7. Summary of Performance Data : Performance data of gloves based on ASTM D3578-01 and FDA 1000 ml watertight test. | TEST | ASTM D3578-01 | CASHMERE POWDER FREE LATEX 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)<br>(Single Layer)<br>Finger | Min 0.08 | 0.10 minimum | | Palm | Min 0.08 | 0.10 minimum | | 5. Physical Properties<br>Before Aging<br>Tensile Strength (Mpa) | Min 14 | 18.7* | | Ultimate Elongation (%) | Min 650 | 956* | | After Aging<br>Tensile Strength (Mpa) | Min 14 | 18.3* | | Ultimate Elongation (%) | Min 500 | 938* | | 6. Powder Content | - | Below 2 mg / glove | | 7. Protein Content | - | Below 50 microgram / gram | · The average result taken from Attachment B2. Page 2 of 3 ATTACHMENT M {2}------------------------------------------------ ### SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my - 8. The performance data of the glove as showed above meet the ASTM D3578-01 Standard and FDA's requirement. Powder content is below 2 mg per glove that meets the FDA Requirements. - 9. The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests. - 10. Conclusion We concluded that the Cashmere Powder Free Latex Examination Gloves meet: - -ASTM D3578-01 Standard - FDA pinhole requirements - - -FDA minimum powder residual content {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines extending from its head. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 6 2002 Mr. Chun Chooi Fong Quality Assurance Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat Kawasan Perindustrain Bukit Merah, 31500 Lahat, Perak, MALAYSIA Re: K022792 Trade/Device Name: Cashmere Non-Sterile, Powder Free Latex Examination Gloves (Polymer Coated Online Chlorinated) Contains 50 Micrograms or Less Of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYY Dated: August 13, 2002 Received: August 22, 2002 Dear Mr. Fong: 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. {4}------------------------------------------------ Page 2 - Mr. Fong 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.qov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ # INDICATIONS FOR USE STATEMENT : Seal Polymer Industries Sdn. Bhd. Applicant K022792 510(K) Number : : Cashmere Non-Sterile, Powder Free Latex Examination Gloves (Polymer Device Name Coated Online Chlorinated) Contains 50 mcgin or less et Tefal Coated Online Chiomatod) Cerritoris per grain Indication For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. .............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC) Prescription Use: ... ... ... ... ... ............ Per 21 CFR 80.109 OR Over-The-Counter ....................... St. Paul's tiv Ulin Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: KC12792 Page 5