Natural Rubber Medical Devices

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Biomedical applications of natural rubber latex …

https://pubmed.ncbi.nlm.nih.gov/34082943/

Don't be Misled by "Latex Free" Claims | FDA

https://www.fda.gov/consumers/consumer-updates/dont-be-misled-latex-free-claims

It is used in numerous medical products, including adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches and blood-pressure monitoring cuffs. …

Natural rubber-containing medical devices; user labeling

https://pubmed.ncbi.nlm.nih.gov/10175218/

Natural rubber-containing medical devices; user labeling--FDA. Final rule Natural rubber-containing medical devices; user labeling--FDA. Final rule Abstract The …

Natural & Synthetic Medical Rubber - The …

https://www.hygenic.com/medical.html

Sheeting is available in three different materials - synthetic rubber, natural rubber latex and thermoplastic elastomer. Film Film is available in two different materials - thermoplastic elastomer and …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.437

The term "natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its …

Uses Of Natural, Silicone, And Isoprene Rubber In …

https://www.kmedhealth.com/uses-of-natural-silicone-and-isoprene-rubber-in-medical-devices-and-technology/

Natural rubber provides good resistance to body fluids. Tubes are used for extensions of urinary bags and suction machines and for transferring fluid Site of injection …

User Labeling for Devices w/Natural Rubber; Small …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-labeling-devices-contain-natural-rubber-21-cfr-801437-small-entity-compliance-guide-guidance

apply to products made from synthetic latex or synthetic rubber that do not include natural rubber in their formulations. FDA has noted an increase in the number of deaths reported …

Guidance for Industry - User Labeling for Devices …

https://www.fda.gov/media/71135/download

The rule applies to all medical devices composed of or containing, or having packaging or components that are composed of, or contain, natural rubber that contacts humans. The …

Recommendations for Labeling - Not Made with Natural …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-labeling-medical-products-inform-users-product-or-product-container-not-made-natural

Center for Devices and Radiological Health The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical …

Medical devices manufactured from latex: European …

https://pubmed.ncbi.nlm.nih.gov/12079423/

Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate …

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