WORLD TRADE G/TBT/Notif.96.208
8July1996
ORGANIZATION
(96-2640)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Food andDrug Administration (57)
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Medical devices
5. Title, number ofpages andlanguage(s) ofthenotified document: Latex-Containing
Devices; UserLabelling (4pages)
6. Description ofcontent: TheAdministration isproposing toamend theregulations to
require allmedical devices containing natural rubber latexthatmaydirectly orindirectly
contact living human tissue tobelabelled withastatement identifying theproduct asone
which contains natural rubber latex andwhich may cause allergic reactions. The
Administration isalsoamending theregulation torequire thathypoallergenicity claims
beremoved from latex medical gloves andother natural rubber latex medical devices
because themodified human draize testcurrently used tosupport hypoallergenicity
claims addresses only chemicals sensitivity, anditisinappropriate fordetermining
protein sensitivity inhumans.
7. Objective andrationale: Health
8. Relevant documents: 61FR32618, 24June1996; 21CFR Part801. Willappear in
theFederal Register when adopted.
9. Proposed dateofadoption/proposed dateofentry intoforce: TheAdministration is
proposing thatthefinalregulation based onthisproposal beeffective 180daysafterthe
dateofitspublication intheFederal Register.
10. Final dateforcomments: 23September 1996
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: