Latex-Containing Medical Devices
November 1, 1996
Latex-Containing Medical Devices
Following is a partial list of natural-rubber-latex-containing medical devices that, under the FDA’s new proposal, would have to bear a label warning of possible allergic reactions:
• Frequently used hospital equipment
urinary catheters and accessories
blood pressure cuffs
intravascular equipment with latex injection ports
electrode pads
tourniquets
enema bags
hot and cold water bottles
rubber sheets
stomach and intestinal tubes
hemodialysis equipment
wound drains
adhesive tape
elastic bandages
medical gloves
• Airway and respiratory devices:
oxygen cannulas
nasopharyngeal airways
tracheal tubes
tracheobronchial suction catheters
breathing bags and mouthpieces
• Cuffed barium enema tips and enteroclysis catheters
• Dental and surgical equipment
dental dams
orthodontic appliances and headgear
anesthetic gas masks
epistaxis balloons
endotracheal tubes
• Contraceptive devices
condoms
cervical caps
diaphragms and accessories
therapeutic douche apparati
Source: Department of Health and Human Services, Food and Drug Administration. Latex-containing devices; user labeling; proposed rule. 61 Fed Reg 32,617 (1996).