Australian Gold® - Tanning Accessories - Performance Standards for Sunlamp Products

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March 01, 2002

RE: Declaration of conformance for Eye Candy� tanning eyewear to regulations called out in 21 CFR 1040.20. Performance Standards for Sunlamp Products.

Based on spectraradiometric transmission testing, we certify that the tanning eyewear known as Eye Candy� is in compliance with safety standards for protective eyewear intended for use with sunlamp products. Specifically, the standard can be found in the Code of Federal Regulation under 21 CFR 1040.20 (c) (4) (ii) and is regulated by the Department of Health and Human Services, Center for Devices and Radiological Health.

The spectral transmittance testing demonstrates that the Eye Candy� eyewear transmit less than one tenth of one percent (.1% or .001) over the wavelength range of 200 through 320 nanometers. Further, they transmit less than one percent (1% or .01) over the wavelength range 320 through 400 nanometers. Eye Candy� eyewear transmits enough of the visible spectrum of light so that a user can easily see the tanning bed controls used to adjust the timer or turn off the tanning device.

Although not specifically required by the regulation stated above, Eye Candy� eyewear has been tested to verify its UV transmission remains compliant after it is exposed to a UV source typical of what it will encounter in application for a duration equal to the eyewear's expected life. Additional testing assured the eyewear's integrity and transmittance properties remain unaffected after being exposed to many typically used eyewear cleaning agents. Finally, subject testing and user evaluations were collected to assure its design characteristics and use instructions adequately meet the eyewear's intended purpose.

Sincerely,

Spectrum Products Inc.

Greg Bender
Director of Regulatory Affairs

Eye Protection Products:

	SunGlobes�
	Special-Eyez�
	Australian Gold� Eye Candy�
	Australian Gold� No Rays�
	SunClipse�