Medical Specialties 3M Health Care PRODUCT CLINICAL DATA SUMMARY Product number 7335 [formerly MSX-6559A] 3M Low Profile Hook with Adhesive Effective: September 2008 This product is not intended for wound management but incidental skin contact is possible. Based on the low potential for any significant skin contact, an evaluation of existing toxicity test data and an assessment of the ingredients, Low Profile Hook 7335 is safe for its intended use. The adhesive used on this product has been subjected to the following biocompatibility studies. In Vitro Cytotoxicity (Agar Overlay) Protocol reference: Guess, W. L. et al; "Agar Diffusion Method for Toxicity Screening of Plastics on Cultured Cell Monolayers" J. Pharm. Sci. 54:15451547 (1965).(HRFE 00915) Results: 0.0/0.0 Acute Primary Skin Irritation in Albino Rabbits Protocol reference: Draize: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics (1965). Published by the Editorial Committee of the Association of Food and Drug Officials of the United States. (HRFE 00915.) Results: 0.0/8.0 These tests are in accordance with the ISO 10993 Part-1 "Biological Evaluation of Medical Devices", as put forth by the FDA. All laboratory testing was conducted in accordance with the FDA Good Laboratory Practices Regulation of 1978. It is the responsibility of our customers to determine the final suitability of our products for their application.