COLOURED POWDWR-FREE SURGICAL GLOVES

{0}------------------------------------------------ ## KEMWELL Kemwell International Ltd. 3-B, II PHASE, PEENYA BANGALORE 560 058, INDIA PH : 91-80-8395701/8392354 TLX : 845-5078 KIPL IN FAX : 91-80-8391450/8396345 APR - 8 1998 K980412 Attachment I ## 510(k) SUMMARY This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510 (k) number is : | 1. Submitter's identification | C ALVA<br>Kemwell International Ltd.<br>3-B, Peenya, II Phase<br>Bangalore 560 058, INDIA. | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Summary prepared | January 19, 1998 | | 2. Name of the Device | Coloured Powder-free Latex Surgical<br>Gloves. | | 3. Predicate Device Information | Class I powder-free Latex Surgical Gloves<br>which meets the requirements of ASTM D<br>3577-91. The equivalent device identified in<br>the market is SAFESKIN-SUPRA of<br>Safeskin Corporation, USA(This product is<br>of natural colour). | | 4. Device Description | Classified by FDA's General and Plastic<br>Surgery Device Panel as Class 1, 21 CFR<br>878.4460, Surgical Powder-free Latex<br>Gloves, 79KGO and meets all requirements<br>of ASTM standard D-3577-91. | | 5. Intended Use | This device is intended to be used as a single<br>use disposable sterile surgical glove. | | 6. Comparison to Predicate Devices | Kemwell International Ltd. Powder-free<br>Latex Surgical Gloves is substantially<br>equivalent in safety and effectiveness to the<br>gloves sold by Safeskin Corporation USA,<br>the brand name SAFESKIN-SUPRA. | {1}------------------------------------------------ ## KEMWELL Kemwell International Ltd. 3-B, II PHASE, PEENYA BANGALORE 560 058, INDIA PH : 91-80-8395701/8392354 TLX : 845-5078 KIPLIN FAX : 91-80-8391450/8396345 - 7. Discussion of Non-clinical Tests performed for determination of substantial equivalence are as follows: The standards used for Coloured Powder-free Latex Surgical Gloves production are based on ASTM-D-3577-91. All test meet requirements of Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5. The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 1.5. Inspection Level 1 meeting these requirements. Primary skin Irritation and Skin sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritation or sensitization reactions. There are no special labelling claims and we do not claim our gloves as hypoallergenic on our labels. Kemwell International Ltd., operates in compliance with FDA's GMPs. 8. Discussion of Clinical Tests Performed: Not applicable - there is no hypoallergenic claim. Un - 9. Conclusions: Kemwell International Ltd. Coloured Powder-free Latex Surgeon's Glove conform fully to ASTM-D-3577-91 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labelling claims as shown by data in our 510 (k). There are no safety/efficacy issues or new claims from the "Substantial equivalence" products cited. Based on the non-clinical tests our product has demonstrated to be as safe as effective as our predicate device. For Kemwell International Ltd., SIGNATURE: C. ALVA, General Manager (Technical) DATE:19-1-1998 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 8 1998 Kemwell International, Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent for Kemwell International Ltd. MDI Consultants 55 Northern Boulevard, Suite 410 Great Neck, New York 11021 Re : K980412 Green Powder-Free Latex Surgical Gloves Trade Name: Regulatory Class: I Product Code: KGo Dated: January 29, 1998 Received: February 3, 1998 Dear Ms. Goldstein-Falk: 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 aqainst 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. ਜੋ 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 regulation may result in regulatory 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 obligation you might have under sections 531 through 542 of {3}------------------------------------------------ Page 2 - Ms. Goldstein-Falk 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 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" (21 CFR 807.97). 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, Patricia Cucciniello Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | Page | 1 of 1 | |----------------|--------| | Attachment III | | | 510(k) Number (if known): | K980412 | |---------------------------|---------------------------------------------------| | Device Name: | Green Coloured Powder-free Latex Gloves Surgeon's | Indications For Use: This Surgeon's Glove is a device made of naturel rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | and General Hospital Devices | | |------------------------------|---------| | 510(k) Number | K980412 | | Prescription Use (Per 21 CFR 801.109) | CR | Over-The-Counter Use | X | |---------------------------------------|----|----------------------|---| |---------------------------------------|----|----------------------|---| (Optional Format 1-2-96) . .