Recall Z-3290-2026— American Nitrile Operations Llc

Name: FDA recall Z-3290-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Class II · Ongoing

Class II FDA medical device recall by American Nitrile Operations Llc, initiated 2026-08-14. It names one FDA 510(k) clearance: K220825. Product: Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examination gloves. Reason: Gloves 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..

Recalling firm: American Nitrile Operations Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-08-14
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K220825 — Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC·cleared 2022-07-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examination gloves

Reason for recall

Gloves 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.