Navigation Links
FDA Clears First Medical Product Made From Yulex(R) Natural Rubber
Date:4/24/2008

FDA provides 510(k) on examination gloves made from U.S.-sourced guayule

rubber that is naturally safe for people with Type I latex allergy

MARICOPA, Ariz., April 24 /PRNewswire/ -- Yulex Corporation, a company that produces natural rubber found to be safe for medical devices, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the first medical device made from guayule, a desert crop native to the U.S. Southwest. The examination gloves made with patented Yulex(R) natural rubber, and cleared by the FDA, do not contain proteins associated with allergic reactions to latex products from Hevea brasiliensis, and are naturally Hevea latex-free.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080424/LATH031)

"We have worked closely with Hevea latex-sensitive individuals, the medical device industry, ASTM International (ASTM) and the FDA to bring this safe alternative to the marketplace," says Jeffrey Martin, president and chief executive officer of Yulex Corporation. "We are pleased with the FDA's guidance and look forward to launching several other guayule-based products currently in the pipeline."

"With more hospitals becoming latex-safe and latex-free, Yulex natural rubber now provides a safe alternative to both healthcare workers and patients who are sensitized to Hevea latex," says Dr. Katrina Cornish, senior vice president of research and development at Yulex. While a scientist at the United States Department of Agriculture -- Agricultural Research Service (USDA-ARS) in the 1990s, Dr. Cornish developed and patented the first process for producing guayule natural rubber for medical devices.

After the AIDS crisis increased latex glove use dramatically in the 1980s, several Type I latex allergy deaths were reported due to the high amounts of residual Hevea protein contained in medical products. As a consequence, the FDA initiated strict regulatory requirements of all products made with Hevea natural rubber latex, and the USDA-ARS began conducting research and development to identify a safer, domestic source for latex. Yulex Corporation then licensed basic technology from the USDA-ARS, and, after years of development, Yulex established guayule as an industrial crop and developed the manufacturing technologies to produce guayule natural rubber commercially.

In 2006, ASTM created a new latex category specifying, for the first time, safety standards based on protein content without lowering the performance standards to accommodate synthetic materials, and Yulex natural rubber is the only material that meets the category's safety and performance requirements.

To learn more about Yulex Corporation, visit http://www.yulex.com.

ABOUT YULEX CORPORATION

A renewable and sustainable enterprise, Yulex Corporation applies intelligent crop science and proprietary clean technology to create biobased medical products from guayule (why-YOU-lee), a plant native to the North American high desert and now an international industrial crop. Yulex(R) natural rubber provides medical device manufacturers with a natural rubber that is naturally free of the allergens associated with Type I Latex Allergy. Through Yulex Corporation's innovations, a new industry producing natural rubber, green fuel and non-toxic adhesives is born. For more, visit http://www.yulex.com.


'/>"/>
SOURCE Yulex Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. DJO Incorporateds Pending Merger With ReAble Therapeutics Clears U.S. Antitrust Review
2. Federal Trade Commission Clears Kyphons Acquisition of Non-Vertebroplasty Spine-Related Assets of Disc-O-Tech
3. FDA Clears OmniWave(TM) Endovascular System for Clot Removal in Peripheral Blood Vessels
4. FDA Clears Biospace meds Revolutionary Low Dose Xray Imager
5. New filter clears up fiber optic communications
6. FDA Clears Expanded Use of Xofts Axxent(R) Electronic Brachytherapy System for all Radiation Therapy Indications
7. Device That Clears Debris From Artery Aids Blood Flow in PCI
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. GlaxoSmithKline Recognizes University of Michigans Dr. Daniel F. Hayes as the First Recipient of the Gianni Bonadonna Breast Cancer Award
10. Kewaunee Scientific Announces First Quarter Results and Quarterly Dividend
11. Genmab Announces 2007 First Half Year Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 Houston Methodist Willowbrook ... Cy-Fair Sports Association to serve as their official ... Houston Methodist Willowbrook will provide sponsorship support, athletic ... with association coaches, volunteers, athletes and families. ... Cy-Fair Sports Association and to bring Houston Methodist ...
(Date:6/23/2016)... , June 23, 2016   EpiBiome , a ... $1 million in debt financing from Silicon Valley Bank ... automation and to advance its drug development efforts, as ... facility. "SVB has been an incredible strategic ... services a traditional bank would provide," said Dr. ...
(Date:6/23/2016)... 2016 Apellis Pharmaceuticals, Inc. today announced ... of its complement C3 inhibitor, APL-2. The trials ... dose studies designed to assess the safety, tolerability, ... in healthy adult volunteers. Forty subjects ... single dose (ranging from 45 to 1,440mg) or ...
(Date:6/23/2016)... ... June 23, 2016 , ... ClinCapture, the only ... Center and will showcase its product’s latest features from June 26 to June ... scientific poster on Disrupting Clinical Trials in The Cloud during the conference. ...
Breaking Biology Technology:
(Date:4/26/2016)... DUBLIN , April 27, 2016 ... of the  "Global Multi-modal Biometrics Market 2016-2020"  report ... ) , The analysts forecast ... a CAGR of 15.49% during the period 2016-2020.  ... a number of sectors such as the healthcare, ...
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
(Date:4/14/2016)... , April 14, 2016 ... Malware Detection, today announced the appointment of Eyal ... new role. Goldwerger,s leadership appointment comes at ... heels of the deployment of its platform at several ... biometric technology, which discerns unique cognitive and physiological factors, ...
Breaking Biology News(10 mins):