What is FDA Low Dermatitis Potential claim?
It’s an FDA approved claim that gloves were clinically tested and have a reduced potential to cause skin irritation. Reduced potential for sensitizing users to rubber chemical additives, and reduced potential for causing reaction in individuals sensitized to rubber chemical additives.
SW® nitrile gloves were clinically tested and proven for:
- FDA Approved Claim- a product feature that has been reviewed and proven by FDA experts to be safe and effective.
- Clinically Tested- gloves were tested on minimum 200 people for skin sensitization with all negative results.
- Independent Testing Laboratory- tested by an FDA registered and certified US laboratory and headed by a board-certified dermatologist.
- Verified Skin Safe- removes the user’s risk of allergic reactions, gloves will not induce contact dermatitis or Type IV hypersensitivity reaction.
- Cleaner glove- lesser to non-detectable chemical residues.
- 510K Certified- a medical grade glove that meets ASTM and FDA standards.
- Responsible Manufacturing- only 9 manufacturers, including SW, have 510K with Low Dermatitis Potential claim.
Clinical Trial (Human Testing)
A patch of glove was placed on the person’s back for a period, with fresh patch replacement every 2 days and observed by lab for skin reactions.
- Conducted in two stages, tested on minimum 50 people first, gloves must not cause skin sensitization to proceed on the next stage of testing 150 people or more.
- SW had an exclusive panel of subjects who tested the patches of gloves, that represents racial and gender diversity in US population.
- Manufacturers who wish to test are exposed to the high cost of the clinical study and risk not meeting 100% compliance on negative results.
Which SW gloves have Low Dermatitis Potential claim?
All SW nitrile gloves have been approved for the LDP claim except DriTek® models: PF-95GY, MM-11GR and MM-11BK.
Who benefits from Low Dermatitis Potential gloves?
- Users with sensitive skin or allergic tendency will see a benefit from SW gloves in that the agitating chemicals used to manufacture gloves are reduced through a unique post process. The process removes up to 75% of unwanted unneeded chemicals.
- Besides being healthier than normal nitrile gloves, workspaces containing sensitive materials will benefit from cleaner gloves. Less residue transferred between gloves and surface contact.