Yulex Glove Prospective Study in Spina Bifida

This study is to evaluate the safety of Yulex gloves when used by individuals who have
documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a
different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex
and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves
for use in the general population and has recognized and labeled these gloves as Hevea
Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for
development of allergy because Yulex does contain a small amount of Guayule protein. Yulex
Corporation has proposed doing further studies to demonstrate safety and lack of
allergenicity in a population that is prone to latex allergy. In the proposed pilot study,
the investigators goal is to complete the protocol on 10 adults with spina bifida who are
allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder
and bowel care for approximately 30 minutes daily over a 3 month period. The investigators
anticipate that the investigators will need to recruit and enroll up to 50 study
participants to achieve a final sample of 10 adults with complete study data. Individuals
with a history of anaphylaxis will be excluded from the study. The study participants will
be tested for Yulex allergy by Glove Puncture Test as well as serology at the beginning and
end of the study. The FDA Devices group has reviewed the study design and agreed that this
is a suitable first pilot study.