Halyard nitrile exam gloves failed chemical permeation performance specifications
Halyard Purezero Ultraviolet Nitrile Exam Gloves are being recalled because they failed to meet specifications for chemical permeation performance. 452,500 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of protective equipment that fails its barrier specification, a risk of harm with no injuries reported in the source.
Plain-English summary
Halyard Purezero Ultraviolet Nitrile Exam Gloves, reference numbers 48771 (XS), 48772 (Small), 48773 (Medium), 48774 (Large) and 48775 (XL), are being recalled. The action covers 452,500 units.
The stated reason is that the nitrile exam glove failed to meet specifications for chemical permeation performance. Permeation performance determines how well the glove resists chemicals passing through it to the wearer's skin. The FDA classified the action as Class II.
Distribution was within the United States, in Georgia, California, New Jersey, Massachusetts, New York and North Carolina. The gloves are supplied to healthcare and laboratory settings.
Facilities should identify affected stock using the reference numbers and UDI codes in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
- Manufacturer
- O&M HALYARD INC
- Affected units
- 452,500
Distribution
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