Think about how much trust is required every time medical professionals don a piece of PPE to confront an unknown situation.
Billions of nitrile gloves are produced every year for use in research and medical laboratories handling dangerous substances.
Like any mass-produced product, defects are always a possibility and customers need to know they are protected.
All nitrile gloves are subjected to rigorous testing which includes exposure to different environmental conditions, physical stretching and contact with chemicals.
Nitrile glove manufacturers publish results showing, among many things, glove thickness, tensile strength and resistance to common chemotherapy drugs to build confidence in the quality of their gloves.
With the number of cases of accidental Fentanyl overdose on the rise, nitrile gloves must be able to demonstrate protection against even a minute level of exposure.
Nitrile gloves that have passed these tests are permitted to be sold on the market and perform with very consistent results.
If a nitrile glove manufacturer discovered a problem with a batch of gloves, what mechanism is there to quickly remove them from the marketplace?
To address this concern, nitrile gloves were recently given a class one medical device designation.
Class one medical devices carry very strict requirements for labeling so that individual items can be identified.
Nitrile gloves are now required to be registered with the FDA and each box and carton must display a UDI (Unique Device Identification) which is to be readable by humans and a machine-readable version as well (a barcode).
With a UDI in place, should a recall situation arise, bad batches can be culled quickly and stopped from entering the USA markets.
An additional consequence of the UDI requirement for nitrile gloves may begin to be felt come September 24th, 2022.
This is when the FDA will begin seizing all imported nitrile gloves that are not labelled with a UDI and registered with the FDA.
What is the best nitrile glove for my lab or medical center?
Stellar Scientific’s Cool Blue nitrile gloves have a satiny soft finish, are cool to the touch and do not cause hand fatigue, even when wearing them for hours at a time.
Cool Blue nitrile gloves have been verified to protect against contact with Fentanyl and will repel ten of the most popular chemotherapy drugs for up to 240 minutes.
Stellar Scientific Cool Blue nitrile gloves are FDA registered and in full compliance with the new regulations
Do Stellar Scientific Cool Blue nitrile gloves have purchasing codes?
Yes!
Purchasers who are required to match codes when buying nitrile gloves will be happy to know Cool Blue gloves have the following codes: