Data / Medical devices / United States / American Nitrile Operations LLC
American Nitrile Operations LLC: FDA-registered device maker in Grove City, OH, United States, 1 510(k) clearance
American Nitrile Operations LLC is registered with the FDA (registration 3024755882) in Grove City, OH, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 8, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024755882
- Address
- 3500 Southwest Blvd, Grove City, OH, United States, 43123
- Owner or operator
- American Nitrile Operations LLC (10086326)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 31, 2022
- Registered through
- 2026
- Brand names listed
- Ammex 1st Choice, Better Touch, CITADEL, DenTouch, Equate, Granite, Opportunity Flex, Opportunity Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 8, 2022 | K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | LZA | Substantially Equivalent | American Nitrile Operations, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 14, 2026 | 99748 | Class II | Ongoing | Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.