ClearanceBrief
Recall Z-3291-2026 ยท LZA Polymer Patient Examination Glove

American Nitrile Operations Llc

Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove

DateSep 25, 2026 (initiated Aug 14, 2026)
StatusOpen, Classified
ReasonGloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.
Root causeProcess control
ActionFirm began notifying its VA customers on August 15, 2026 via email. Instruction to Customers: 1. Immediately cease all use of the affected products. 2. Notify all users throughout your facility of the product recall. 3. Examine your inventory and immediately quarantine the affected lots to avoid accidental use 4 Contact distributor for replacement.
Quantity17,481,000
DistributionUS Nationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K220825Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
American Nitrile Operations, LLC, Jul 8, 2022