Data / Medical devices / United States / American Armor Gloves
American Armor Gloves: FDA-registered device maker in West Columbia, SC, United States, 4 510(k) clearances
American Armor Gloves is registered with the FDA (registration 3026363353) in West Columbia, SC, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026363353
- Address
- 4777 12th Street Extension, West Columbia, SC, United States, 29172
- Owner or operator
- American Armor Gloves (10087302)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 10, 2023
- Registered through
- 2026
- Brand names listed
- NEPHRON NITRILE, Nephron Nitrile, Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl), Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 20, 2024 | K232654 | Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) | LZA | Substantially Equivalent | Nephron Nitrile, LLC | accessdata.fda.gov |
| January 16, 2024 | K233970 | Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | LZA | Substantially Equivalent | Nephron Nitrile, LLC | accessdata.fda.gov |
| June 6, 2023 | K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | LZA | Substantially Equivalent | Nephron Nitrile, LLC | accessdata.fda.gov |
| February 9, 2023 | K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | LZA | Substantially Equivalent | Nephron Pharmaceuticals Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
Updated March 20, 2024. 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.