Testing Confirms Fentanyl-Heroin Resistant Glove
Ohio Glove Company Announces FDA 510(k) Medical Approval for Get-A-Grip and Intercept Free Nitrile Glove for First Responder Personal Protection.
P H & S Products, LLC has been awarded by the FDA a 510(k) medical device Class I listing for a two-tone single-use only, examination grade glove for protection against fentanyl, heroin, and gastric acid per the ASTM D6978-05 standard. Using these 510(k) numbers, the FDA regulates and certifies the safety of these products to provide a barrier for the bare hand encountering these opioids alone or a mixture of all three substances.
The 510(k) certifications were awarded to both the Get-A-Grip two tone powder free, nitrile glove with a diamond grip pattern and the Intercept Free powder free nitrile NFPA (National Fire Protective Agency) approved two tone, accelerator free glove. Both glove styles offer maximum protection.
To receive the 510(k) approval the Get-A-Grip and Intercept Free gloves were evaluated for resistance to fentanyl, heroin, and gastric acid by the Akron Rubber Development Laboratories (ARDL). ARDL testing showed the fentanyl, heroin and gastric acid did not permeate the gloves up to 240 minutes of exposure.
With the help of U.S. Congressman Bill Johnson of Ohio, testing was expedited through the appropriate channels.
Congressman Johnson states “This is a tremendous accomplishment for the people of Summit Glove and its subsidiary, PH&S Products, but more importantly it will better protect first responders in Eastern Ohio and across the country from the deadly scourge of Fentanyl. I was glad to help cut through red tape at the DEA to secure the materials needed to test the gloves for approval. Fentanyl is killing Americans all across the country – our friends, neighbors, and in some cases family members – at unprecedented rates. Any tool that will keep law enforcement and first responders safe in this fight is very welcome”.
As the heroin and fentanyl epidemic continues to grow, the professionals who come in accidental contact with these dangerous drugs are at great personal risk. Fentanyl is a powerful synthetic opioid 50 to 100 times more potent than morphine. As little as two milligrams, about the size of five grains of salt, can cause negative health effects including trouble breathing, dizziness, and possible overdose.
PH&S Products (www.phs-products.com), an ISO 9001 (with design) certified company, is a leader in design and development of innovative hand protection for municipal government agencies, emergency response teams and other public health and safety providers.
Call 888-688-6768 to request a sample for evaluation or visit our website at phs-products.com