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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).