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Sign in to claim this brandINNOVATIVE HEALTHCARE CORPORATION
US
Last updated May 23, 2026
What INNOVATIVE HEALTHCARE CORPORATION makes
The company manufactures single-use gloves for medical examination, treatment, and surgical procedures, including nitrile, hevea-latex, vinyl, polychloroprene, and polyisoprene varieties. Products are available in non-powdered forms, with some designed for radiation attenuation. Specific lines include examination gloves, surgical gloves, and specialized variants like nitrile gloves with antimicrobial coatings or textured surfaces for grip.
These devices are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within the United States, adhering to applicable U.S. 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 Innovative Healthcare Corporation manufacture?
Innovative Healthcare Corporation specializes in single-use gloves for medical, examination, treatment, and surgical procedures. Their product line includes nitrile, hevea-latex, vinyl, polychloroprene, and polyisoprene gloves, all designed in non-powdered forms. Some gloves are engineered for specific purposes, such as radiation attenuation, while others feature specialized coatings or textures for enhanced grip. These devices are intended for direct patient contact in clinical settings.
Where is Innovative Healthcare Corporation based, and how does that affect its devices?
Innovative Healthcare Corporation is based in the United States. As a U.S.-based manufacturer, its devices are subject to U.S. medical device regulations, including requirements for safety, performance, and compliance with the FDA’s regulatory framework. The company’s location also means its products are designed to meet U.S. market standards, though they may also comply with international regulations if applicable to their global distribution.
Which regulatory registries or databases list Innovative Healthcare Corporation’s devices?
Innovative Healthcare Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their lifecycle, ensuring traceability and compliance with FDA requirements. Listing in this database helps healthcare providers, regulators, and other stakeholders verify the identity and regulatory status of the company’s products.
How are Innovative Healthcare Corporation’s gloves classified under FDA regulations?
Innovative Healthcare Corporation’s gloves are classified under FDA’s Class I and Class II regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the type of glove (e.g., examination vs. surgical), material, and intended use, ensuring appropriate oversight based on potential risk to patients.
Why do some of Innovative Healthcare Corporation’s gloves have specialized features like radiation attenuation?
Some of Innovative Healthcare Corporation’s gloves, such as the radiation attenuating Hevea-latex surgical/procedural glove, include specialized features to address specific clinical needs. Radiation-attenuating gloves are designed to reduce exposure to X-rays or other imaging radiation during procedures like fluoroscopy or dental X-rays, protecting both the wearer and patients. These features are incorporated based on user requirements in high-exposure environments, demonstrating how the company tailors its products to meet diverse medical scenarios.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 802020693
Catalogue (284)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NitriDerm® Ultra Black | 187450 | FDA UDI | Class I | Active |
| Pulse® LOGIC™ | 173300 | FDA UDI | Class I | Active |
| DermAssist® PF | 133800 | FDA UDI | Class I | Active |
| Pulse® CR Aqua | 194102 | FDA UDI | Class I | Active |
| DermAssist® | 163350 | FDA UDI | Class I | Active |
| DermAssist® COATS™ | 124300 | FDA UDI | Class I | Active |
| Prestige® Orthopaedic | 131600 | FDA UDI | Class I | Active |
| DermAssist® Stretch | 163100 | FDA UDI | Class I | Active |
| NitriDerm® | 135290 | FDA UDI | Class I | Active |
| NitriDerm® Ultra Orange™ | 199400 | FDA UDI | Class I | Active |
| Pulse® PRECISE™ | 176300 | FDA UDI | Class I | Active |
| DermAssist® PF | 133550 | FDA UDI | Class I | Active |
| DermAssist® COATS™ | 124100 | FDA UDI | Class I | Active |
| Prestige® PI Select™ | 146850 | FDA UDI | Class I | Active |
| NitriDerm® EP | 182200 | FDA UDI | Class I | Active |
| NitriDerm® COATS™ | 125352 | FDA UDI | Class I | Active |
| NitriDerm® Soothe™ | 126200 | FDA UDI | Class I | Active |
| NitriDerm® Ultra Pro™ | 188050 | FDA UDI | Class I | Active |
| Pulse® Ultra Black | 186350 | FDA UDI | Class I | Active |
| ProDerm™ | 155050 | FDA UDI | Class I | Active |
| NitriDerm® EP Orange® | 189350 | FDA UDI | Class I | Active |
| NitriDerm® EP | 182400 | FDA UDI | Class I | Active |
| Prestige® PI Select™ | 146900 | FDA UDI | Class I | Active |
| Pulse® CR Aqua | SPK194 | FDA UDI | Class I | Active |
| NitriDerm® EP Orange® | 189300 | FDA UDI | Class I | Active |
| NitriDerm® | 277202 | FDA UDI | Class I | Active |
| NitriDerm® Ultra White | 167100 | FDA UDI | Class I | Active |
| Pulse® Ultra Black | 186050 | FDA UDI | Class I | Active |
| DermAssist® PF | 133750 | FDA UDI | Class I | Active |
| NitriDerm® | 277352 | FDA UDI | Class I | Active |
| Radiaxon® | XR3570-85 | FDA UDI | Class I | Active |
| Dental Grip ® Powder-Free | 390-0016 | FDA UDI | Class I | Active |
| Prestige® Orthopaedic | 131700 | FDA UDI | Class I | Active |
| NitriDerm® Ultra Orange™ | 199450 | FDA UDI | Class I | Active |
| Radiaxon® | XR497500 | FDA UDI | Class I | Active |
| NitriDerm® | 107300 | FDA UDI | Class I | Active |
| NitriDerm® | 109350 | FDA UDI | Class I | Active |
| DermAssist® Stretch | 162100 | FDA UDI | Class I | Active |
| Prestige® PI Select™ | 146600 | FDA UDI | Class I | Active |
| Pulse® CR Aqua | 194202 | FDA UDI | Class I | Active |
| Prestige® Orthopaedic | 131650 | FDA UDI | Class I | Active |
| DermAssist® COATS™ | SPK124 | FDA UDI | Class I | Active |
| NitriDerm® 200 | 159202 | FDA UDI | Class I | Active |
| Black Wolf™ | 127050 | FDA UDI | Class I | Active |
| NitriDerm® | 109200 | FDA UDI | Class I | Active |
| Prestige® Orthopaedic | 131850 | FDA UDI | Class I | Active |
| DermAssist® PF | 133700 | FDA UDI | Class I | Active |
| NitriDerm® | 108200 | FDA UDI | Class I | Active |
| NitriDerm® | 111350 | FDA UDI | Class I | Active |
| Pulse® PURE™ | SPK178 | FDA UDI | Class I | Active |
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