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Sign in to claim this brandBalco Industries Inc.
US
Last updated May 25, 2026
What Balco Industries Inc. makes
Balco Industries Inc. manufactures nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are designed for medical examinations and procedures, ensuring barrier protection for both patients and healthcare providers.
The company’s products fall under Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) system. 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 Balco Industries Inc. manufacture?
Balco Industries Inc. specializes in nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are primarily used as protective barriers during medical examinations and procedures to safeguard both patients and healthcare workers. The company focuses exclusively on this category of Class I devices.
Where is Balco Industries Inc. based?
Balco Industries Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, particularly for devices marketed in North America and beyond.
Which regulatory registries or databases list Balco Industries Inc.’s devices?
Balco Industries Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency for Class I medical devices, including nitrile gloves, by assigning a unique identifier to each product.
How are Balco Industries Inc.’s devices classified under medical device regulations?
Balco Industries Inc.’s nitrile examination and treatment gloves fall under Class I medical device classification. This classification is typically assigned to low-risk devices like gloves, where general controls (e.g., good manufacturing practices) are sufficient for ensuring safety and effectiveness.
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
- 055891774
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Handcovers | PNK4003 | FDA UDI | Class I | Active |
| Handcovers | BKN6003 | FDA UDI | Class I | Active |
| Handcovers | PFN4001 | FDA UDI | Class I | Active |
| Handcovers | PNK4002 | FDA UDI | Class I | Active |
| Handcovers | BKN4001 | FDA UDI | Class I | Active |
| Handcovers | BKN4002 | FDA UDI | Class I | Active |
| Handcovers | BKN4003 | FDA UDI | Class I | Active |
| Handcovers | PNK4001 | FDA UDI | Class I | Active |
| Handcovers | BKN6001 | FDA UDI | Class I | Active |
| Handcovers | PNK4004 | FDA UDI | Class I | Active |
| Handcovers | BKN4004 | FDA UDI | Class I | Active |
| Handcovers | BKN6002 | FDA UDI | Class I | Active |
| Handcovers | PFN4004 | FDA UDI | Class I | Active |
| Handcovers | PFN4003 | FDA UDI | Class I | Active |
| Handcovers | PFN4002 | FDA UDI | Class I | Active |
| Handcovers | BKN6004 | FDA UDI | Class I | Active |
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