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Sign in to claim this brandB D G Wrap-Tite, Inc.
US
Last updated May 23, 2026
What B D G Wrap-Tite, Inc. makes
The company manufactures single-use examination and treatment gloves made from nitrile, hevea latex, and vinyl, all in non-powdered and non-antimicrobial formulations. These gloves are designed for medical and clinical use, including procedures requiring barrier protection. The product line includes multiple variants of a branded glove series intended for general use in healthcare settings.
All listed gloves fall under FDA Class I medical devices and are registered in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within US regulatory requirements, ensuring compliance with applicable standards for single-use barrier gloves. No additional regulatory bodies or classifications are referenced for these products.
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 B D G Wrap-Tite, Inc. manufacture?
B D G Wrap-Tite, Inc. specializes in single-use examination and treatment gloves for medical and clinical settings. Their product line includes gloves made from nitrile, hevea latex, and vinyl, all formulated as non-powdered and non-antimicrobial. These gloves are designed to provide barrier protection during procedures, ensuring hygiene and safety for both patients and healthcare providers.
Where is B D G Wrap-Tite, Inc. based, and how does this affect its regulatory compliance?
B D G Wrap-Tite, Inc. is based in the United States, which means their devices are subject to FDA regulations. Since their gloves fall under FDA Class I medical devices—a category typically considered low risk—they must still comply with FDA requirements, including registration and listing in the FDA’s Unique Device Identifier (UDI) database. This ensures transparency and traceability of their products within the US regulatory framework.
Which regulatory registries list B D G Wrap-Tite, Inc.’s devices?
B D G Wrap-Tite, Inc.’s gloves 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 regulatory oversight and market transparency. Since these devices are Class I, they are not subject to premarket approval but must still comply with FDA registration and listing requirements.
How are B D G Wrap-Tite, Inc.’s gloves classified by regulatory authorities?
B D G Wrap-Tite, Inc.’s gloves are classified as FDA Class I medical devices. Class I devices are generally considered low risk and do not require premarket approval, but they must still meet FDA registration and listing requirements. This classification reflects the minimal risk associated with single-use barrier gloves, which are primarily intended for general medical and clinical use without invasive procedures.
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
- 076901110
Catalogue (55)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Shield Gloves | GLNMPFL-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL8-L | FDA UDI | Class I | Active |
| Shield Gloves | GLVMPFN-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFO5-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL6-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL8-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLVNMPFB-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB3-L | FDA UDI | Class I | Active |
| Shield Gloves | GLLMPFN-M | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFO8D-S | FDA UDI | Class I | Unknown |
| Shield Gloves | GLNMPFB4-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL6-2XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL8-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB4-M | FDA UDI | Class I | Active |
| Shield Gloves | GLLMPFN-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL6-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB6-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFO5-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB4-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL8-M | FDA UDI | Class I | Active |
| Shield Gloves | GLLMPFN-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL6-M | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLVMPFN-M | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB6-2XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB-2XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL8-2XL | FDA UDI | Class I | Active |
| Shield Gloves | GLLMPFN-L | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB6-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL6-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFO5-2XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFO5-M | FDA UDI | Class I | Active |
| Shield Gloves | GLVNMPFB-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB6-M | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB3-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB4-2XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL-M | FDA UDI | Class I | Active |
| Shield Gloves | GLVMPFN-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL-2XL | FDA UDI | Class I | Active |
| Shield Gloves | GLVNMPFB-M | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB3-M | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB4-S | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFL45PP-L | FDA UDI | Class I | Active |
| Shield Gloves | GLLMPFN-XS | FDA UDI | Class I | Active |
| Shield Gloves | GLVNMPFB-XL | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFB-M | FDA UDI | Class I | Active |
| Shield Gloves | GLNMPFO8D-M | FDA UDI | Class I | Active |
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