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Sign in to claim this brandIMPACT PRODUCTS, LLC
US
Last updated May 30, 2026
What IMPACT PRODUCTS, LLC makes
Impact Products, LLC manufactures single-use gloves for medical and personal care, including nitrile, vinyl, and latex varieties designed for examination and treatment procedures. Their portfolio also includes unscented menstrual products such as tampons and pads, intended for personal hygiene use.
The company’s devices are classified under FDA regulations as Class I or Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Impact Products, LLC operates from 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 and personal care products does Impact Products, LLC manufacture?
Impact Products, LLC specializes in single-use gloves and menstrual hygiene products. Their glove portfolio includes nitrile, vinyl, and latex varieties—specifically non-powdered, non-antimicrobial examination and treatment gloves. They also produce unscented menstrual tampons and pads for personal hygiene.
Where is Impact Products, LLC based, and what does that mean for their regulatory oversight?
Impact Products, LLC is based in the United States, which means their devices fall under FDA jurisdiction. The FDA classifies their products as either Class I or Class II, indicating varying levels of regulatory scrutiny based on risk. All their devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking.
Which regulatory registries or databases list Impact Products, LLC’s devices?
Impact Products, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for tracking, reporting, and compliance purposes, which is particularly important for medical and personal care items subject to regulatory oversight.
How are Impact Products, LLC’s gloves and menstrual products classified under FDA regulations?
Impact Products, LLC’s gloves and menstrual products are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the product’s intended use and potential risks.
Are Impact Products, LLC’s devices intended for both medical and non-medical use?
Yes, Impact Products, LLC’s devices serve dual purposes. Their gloves are designed for medical examination and treatment procedures, meeting standards for sterile or clean barrier protection. Meanwhile, their menstrual tampons and pads are intended for personal hygiene use, though they may also be used in non-medical settings where similar protection is needed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- impact-products.com
- —
- —
- [email protected]
- Phone
- 419-841-2891
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 005052360
Catalogue (34)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Diversamed | 8622XL | FDA UDI | Class I | Active |
| The Safety Zone | GREP-MD-1 | FDA UDI | Class I | Active |
| Naturelle | 25030073 | FDA UDI | Class I | Active |
| Diversamed | 8617L | FDA UDI | Class I | Active |
| Diversamed | 8628XL | FDA UDI | Class I | Active |
| The Safety Zone | GREP-SM-1 | FDA UDI | Class I | Active |
| Naturelle | 25176598 | FDA UDI | Class II | Active |
| Diversamed | 8607M | FDA UDI | Class I | Active |
| Diversamed | 8649S | FDA UDI | Class I | Active |
| Diversamed | 8607L | FDA UDI | Class I | Active |
| Diversamed | 8645S | FDA UDI | Class I | Active |
| Diversamed | 8641XL | FDA UDI | Class I | Active |
| Diversamed | 8622M | FDA UDI | Class I | Active |
| Diversamed | 8617XL | FDA UDI | Class I | Active |
| Diversamed | 8645XL | FDA UDI | Class I | Active |
| Diversamed | 8649M | FDA UDI | Class I | Active |
| Diversamed | 8607S | FDA UDI | Class I | Active |
| Diversamed | 8622S | FDA UDI | Class I | Active |
| The Safety Zone | GREP-XL-1 | FDA UDI | Class I | Active |
| Diversamed | 8617M | FDA UDI | Class I | Active |
| Diversamed | 8641M | FDA UDI | Class I | Active |
| Diversamed | 8649XL | FDA UDI | Class I | Active |
| Naturelle | 251765 | FDA UDI | Class II | Active |
| Diversamed | 8628M | FDA UDI | Class I | Active |
| Diversamed | 8622L | FDA UDI | Class I | Active |
| Diversamed | 8645M | FDA UDI | Class I | Active |
| Diversamed | 8628L | FDA UDI | Class I | Active |
| Diversamed | 8607XL | FDA UDI | Class I | Active |
| Diversamed | 8617S | FDA UDI | Class I | Active |
| Naturelle | 25176488 | FDA UDI | Class II | Active |
| Diversamed | 8641S | FDA UDI | Class I | Active |
| Naturelle | 25160273 | FDA UDI | Class II | Active |
| The Safety Zone | GREP-LG-1 | FDA UDI | Class I | Active |
| Diversamed | 8641L | FDA UDI | Class I | Active |
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