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Sign in to claim this brandAMMEX CORPORATION
US
Last updated September 17, 2026
What AMMEX CORPORATION makes
AMMEX Corporation manufactures single-use examination and treatment gloves made from nitrile, vinyl, and natural rubber latex. Their products are available in non-powdered formulations, with some also specified as non-antimicrobial. These gloves are designed for medical, dental, and clinical settings to provide barrier protection during procedures.
The company’s portfolio is classified under FDA’s Class I regulatory category, with devices listed via the 510(k) pathway and included in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, adhering to applicable medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AMMEX Corporation manufacture?
AMMEX Corporation specializes in single-use examination and treatment gloves. Their product line includes nitrile, vinyl, and Hevea-latex gloves, all formulated as non-powdered. Some of their latex gloves are also non-antimicrobial. These gloves are designed for medical, dental, and clinical use to provide barrier protection during procedures.
Where is AMMEX Corporation based?
AMMEX Corporation is based in the United States. The company’s products are developed and manufactured to comply with U.S. medical device regulations, including those governing single-use gloves.
Which regulatory registries or databases list AMMEX Corporation’s devices?
AMMEX Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are also authorised through the FDA’s 510(k) premarket notification pathway, which is used for Class I devices like gloves.
How are AMMEX Corporation’s gloves classified under FDA regulations?
AMMEX Corporation’s gloves fall under the FDA’s Class I regulatory category. This classification applies to low-risk devices like single-use gloves, which typically require less stringent regulatory oversight compared to higher-risk medical devices. The 510(k) pathway is used to demonstrate substantial equivalence to a predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1019 W James St, Kent, WA, 98032
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3023862
- DUNS Number
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Catalogue (275)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AMMEX Professional | ABNPF-S | FDA UDI | Class I | Active |
| AMMEX Professional | APFN46100 | FDA UDI | Class I | Active |
| 1st Choice, AMMEX Professional | 1EINVPFXLBX2 | FDA UDI | Class I | Active |
| AMMEX Professional | VPF64100CS2 | FDA UDI | Class I | Active |
| AMMEX Professional | VPF66100BX3 | FDA UDI | Class I | Active |
| AMMEX Professional | ABNPF-S | FDA UDI | Class I | Active |
| AMMEX Professional | VPF-S | FDA UDI | Class I | Active |
| AMMEX Professional | VPF64100CS4 | FDA UDI | Class I | Active |
| AMMEX Professional | APFN48100 | FDA UDI | Class I | Active |
| 1st Choice | 1EBNXLCS2 | FDA UDI | Class I | Active |
| Gloveworks | GPLHD88100 | FDA UDI | Class I | Active |
| 1st Choice | 1ENXL | FDA UDI | Class I | Active |
| AMMEX Professional | ACNPF44100 | FDA UDI | Class I | Active |
| 1st Chocie | 1MEBNLBX2 | FDA UDI | Class I | Active |
| 1st Choice, AMMEX Professional | 1EBNVPFMBX2 | FDA UDI | Class I | Active |
| AMMEX Professional | VPF64100 | FDA UDI | Class I | Active |
| 1st Choice | 1EBNSP70 | FDA UDI | Class I | Active |
| Gloveworks | GPLHDMP-S | FDA UDI | Class I | Active |
| 1st Choice, AMMEX Professional | 1EINVPFLCS2 | FDA UDI | Class I | Active |
| AMMEX Professional | ABNPF44100BX2 | FDA UDI | Class I | Active |
| AMMEX Professional | ABNPF42100 | FDA UDI | Class I | Active |
| 1st Choice | 1EBNM | FDA UDI | Class I | Active |
| Gloveworks | GWBEN42100 | FDA UDI | Class I | Active |
| Ammex Latex Examination Gloves | K891850 | FDA 510(k) | Class I | Active |
| Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) | K211457 | FDA 510(k) | Class I | Active |
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