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Sign in to claim this brandElite International, Inc.
US
Last updated May 23, 2026
What Elite International, Inc. makes
Elite International, Inc. manufactures disposable vinyl exam gloves, including powdered and powder-free variants. The powder-free line includes formulations with added vitamin complexes, nopal, and lanolin. These gloves are designed for single-use medical and clinical examinations.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the United States.
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 Elite International, Inc. manufacture?
Elite International, Inc. specializes in disposable vinyl exam gloves. Their product line includes both powdered and powder-free versions, with some powder-free gloves featuring additional ingredients like vitamin complexes, nopal, and lanolin. These gloves are intended for single-use medical and clinical examinations.
Where is Elite International, Inc. based?
Elite International, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction.
How are Elite International, Inc.’s devices classified under FDA regulations?
Elite International, Inc.’s disposable vinyl exam gloves are classified as Class I medical devices by the FDA. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, allowing for streamlined regulatory oversight.
Are Elite International, Inc.’s devices listed in any regulatory registries?
Yes, Elite International, Inc.’s devices are listed via the FDA’s 510(k) clearance pathway. This process demonstrates that the manufacturer has shown their products are substantially equivalent to a legally marketed predicate device, meeting FDA requirements for marketing authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- PRRC Contact
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- EUDAMED SRN
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Catalogue (581)
Page 7 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bevel | 2541BKM | FDA UDI | Class I | Active |
| Bevel | 3731CTG | FDA UDI | Class I | Active |
| Bevel | 8741GGWT | FDA UDI | Class I | Active |
| Bevel | 8004BKM | FDA UDI | Class I | Active |
| Bevel | 8742LEPP | FDA UDI | Class I | Active |
| Bevel | 3637GS | FDA UDI | Class I | Active |
| Bevel | 3727RBG | FDA UDI | Class I | Active |
| Bevel | 3690SL | FDA UDI | Class I | Active |
| Bevel | 8736FGMI | FDA UDI | Class I | Active |
| Bevel | 3731BGH | FDA UDI | Class I | Active |
| Bevel | 3680PNM | FDA UDI | Class I | Active |
| Bevel | 8682GTPU | FDA UDI | Class I | Active |
| Bevel | 3712LG | FDA UDI | Class I | Active |
| Bevel | 3690PC | FDA UDI | Class I | Active |
| Bevel | 8742GTWR | FDA UDI | Class I | Active |
| Bevel | 8668GTPU | FDA UDI | Class I | Active |
| Bevel | 2543AG | FDA UDI | Class I | Active |
| Bevel | 3638CW | FDA UDI | Class I | Active |
| Bevel | 2539LG | FDA UDI | Class I | Active |
| Bevel | 2548LG | FDA UDI | Class I | Active |
| Bevel | 8724BCSB | FDA UDI | Class I | Active |
| Bevel | 2549BC | FDA UDI | Class I | Active |
| Bevel | 6547TGBM | FDA UDI | Class I | Active |
| Bevel | 6545SYPW | FDA UDI | Class I | Active |
| Bevel | 6544BCWH | FDA UDI | Class I | Active |
| Bevel | 3727IB | FDA UDI | Class I | Active |
| Bevel | 3719SC | FDA UDI | Class I | Active |
| Bevel | 8740SLDI | FDA UDI | Class I | Active |
| Bevel | 6545PUWH | FDA UDI | Class I | Active |
| Bevel | 8737BCSB | FDA UDI | Class I | Active |
| Bevel | 8729BCDI | FDA UDI | Class I | Active |
| Bevel | 8705RDRB | FDA UDI | Class I | Active |
| Bevel | 2548WT | FDA UDI | Class I | Active |
| Bevel | 2545LG | FDA UDI | Class I | Active |
| Bevel | 3680MB | FDA UDI | Class I | Active |
| Bevel | 3729PT | FDA UDI | Class I | Active |
| Bevel | 8744GGWT | FDA UDI | Class I | Active |
| Bevel | 3648BKM | FDA UDI | Class I | Active |
| Bevel | 2546PT | FDA UDI | Class I | Active |
| Bevel | 8004BGE | FDA UDI | Class I | Active |
| Bevel | 8738GYPO | FDA UDI | Class I | Active |
| Bevel | 8740MASA | FDA UDI | Class I | Active |
| Bevel | 3730CTG | FDA UDI | Class I | Active |
| Bevel | 3638PB | FDA UDI | Class I | Active |
| Bevel | 8738WREG | FDA UDI | Class I | Active |
| Bevel | 2547AG | FDA UDI | Class I | Active |
| Bevel | 3731MOM | FDA UDI | Class I | Active |
| Bevel | 8729CUSY | FDA UDI | Class I | Active |
| Bevel | 8727WREG | FDA UDI | Class I | Active |
| Bevel | 6540DIWT | FDA UDI | Class I | Active |
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