Medical Materials & Technologies

BIOCOMPATIBILITY SUMMARY

Product Name: 3M™ Medical Silicone Tape 2477P

Effective: December 2020

The adhesive used in 3M™ Medical Silicone Tape 2477P has been subjected to the following preclinical

biocompatibility testing by an outside laboratory under GLP:

Cytotoxicity Study Using the ISO Direct Contact Method (Acrylic Adhesive Tested)

The test article was evaluated to determine the potential for cytotoxicity. This study was conducted

based on the requirements of ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in

vitro cytotoxicity. Culture wells of a 6-well tissue culture plate that contained a subconfluent monolayer

of L-929 mouse fibroblast cells were used for testing. Triplicate wells were dosed with either a test

article section, high density polyethylene as a negative control or latex as a positive control. Each article

was placed in direct contact with the L-929 cells. After incubating for 24-26 hours, the cultures were

examined microscopically (100X) for any abnormal cell morphology and cell lysis in proximity to the

articles. Results: The test article showed no evidence of causing cell lysis or cytotoxicity to L-929 cells.

The test article met the requirements of the test since the grade was less than a grade 2 (mild

reactivity).

CLIN-RPT-FINAL-INV-US-05-405329

Cytotoxicity Study Using the ISO Elution Method (Silicone and Acrylic Adhesive Tested)

The test article was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture

test. This study was conducted following the guidelines of ISO 10993-5, Biological evaluation of medical

devices – Part 5: Tests for in vitro cytotoxicity. A single preparation of the test article was extracted in

single strength Minimum Essential Medium (1X MEM) at 37°C for 24 hours. The negative control,

reagent control, and positive control were similarly extracted. Triplicate monolayers of L-929 mouse

hours. Following incubation, the monolayers were examined microscopically for abnormal cell

morphology and cellular degeneration. Results: The test article extract showed no evidence of causing

cell lysis or toxicity and had a grade of 0 (no reactivity). The test article met the requirements of the test

since the grade was less than a grade 2 (mild reactivity).

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ISO Skin Irritation Study in Rabbits (Acrylic Adhesive Tested)

The test article was evaluated for primary skin irritation in rabbits. This study was conducted in

accordance with the guidelines of ISO 10993-10, Biological evaluation of medical devices – Part 10: Tests

for irritation and skin sensitization. Two 25 mm x 25 mm sections of the test article and control article

were topically applied to the skin of each of three rabbits and left in place for a minimum of 23 hours

and a maximum of 24 hours. The sites were graded for erythema and edema at 1, 24, 48 and 72 hours

after removal of the single sample application. Results: There was none to well-defined erythema and

no edema observed on the skin of the animals treated with the test article. The Primary Irritation Index

(PII) for the test article was calculated to be 0.5/8.0. The response of the test article was categorized as

slight.

CLIN-RPT-FINAL-INV-US-05-409807