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Sign in to claim this brandBosma Enterprises
US
Last updated May 24, 2026
What Bosma Enterprises makes
Bosma Enterprises manufactures single-use surgical and examination gloves, including polyisoprene, hevea-latex, polychloroprene, and nitrile varieties, all non-powdered and non-antimicrobial. Their portfolio also includes surgical linen/cushion sets, operating room turnover kits, limb/torso/head restraints, and bucket liners designed for medical and procedural use.
The company’s products are regulated under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. 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 Bosma Enterprises manufacture?
Bosma Enterprises specializes in single-use medical devices primarily for surgical and examination settings. Their portfolio includes non-powdered, non-antimicrobial gloves made from materials like polyisoprene, hevea-latex, polychloroprene, and nitrile. They also produce surgical linen/cushion sets, operating room turnover kits, limb/torso/head restraints, and bucket liners. These products are designed to meet procedural and surgical needs while adhering to regulatory standards.
Where is Bosma Enterprises based, and how does that affect its devices?
Bosma Enterprises is based in the United States, which means its devices are subject to FDA regulations. The company’s products fall under FDA’s Class I and Class II categories, indicating varying levels of regulatory oversight depending on the device’s risk profile. Being U.S.-based also means compliance with domestic manufacturing and safety standards, ensuring alignment with FDA requirements for device authorization.
Which regulatory registries or databases list Bosma Enterprises’ devices?
Bosma Enterprises’ devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory compliance. Listing in this database is a requirement for devices marketed in the U.S., including those manufactured by Bosma Enterprises.
How are Bosma Enterprises’ devices classified under FDA regulations?
Bosma Enterprises’ devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and regulatory history, as outlined in FDA guidelines.
Why do some of Bosma Enterprises’ devices appear under different brand names like Biogel or Gammex?
Some of Bosma Enterprises’ devices may be distributed or marketed under different brand names like Biogel or Gammex due to licensing agreements, private-label contracts, or distribution partnerships. These brands represent the same manufacturer but cater to specific market segments or customer preferences. The underlying product design, materials, and regulatory compliance remain consistent with Bosma Enterprises’ standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bosma.org
- —
- —
- [email protected]
- Phone
- 800-362-5463
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 878070325
Catalogue (509)
Page 4 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bosma Enterprises | 72-50902 | FDA UDI | Class I | Active |
| Biogel | 71-40890 | FDA UDI | Class I | Active |
| Bosma Enterprises | 71-10402 | FDA UDI | Class I | Unknown |
| Bosma Enterprises | 10-7100 | FDA UDI | Class I | Active |
| Gammex | 71-AN86575 | FDA UDI | Class I | Active |
| SensiCare | 71-ME9065 | FDA UDI | Class I | Active |
| Biogel | 71-ML48580 | FDA UDI | Class I | Active |
| Biogel | 71-30580 | FDA UDI | Class I | Active |
| Bosma Enterprises | 10-8020DA | FDA UDI | Class I | Active |
| Triumph | 71-ME2390 | FDA UDI | Class I | Unknown |
| Biogel | 71-40855 | FDA UDI | Class I | Active |
| Biogel | 71-75290 | FDA UDI | Class I | Active |
| Encore | 71-5788001 | FDA UDI | Class I | Active |
| Bosma Enterprises | 10-9030 | FDA UDI | Class I | Active |
| Encore | 71-5787004 | FDA UDI | Class I | Active |
| Biogel | 71-31090 | FDA UDI | Class I | Active |
| Biogel | 71-ML47660 | FDA UDI | Class I | Active |
| Gammex | 71-AN85980 | FDA UDI | Class I | Active |
| Biogel | 71-31085 | FDA UDI | Class I | Active |
| Gammex | 71-AN87290 | FDA UDI | Class I | Active |
| Protexis | 71-CR3ET65 | FDA UDI | Class I | Active |
| Encore | 71-5795006 | FDA UDI | Class I | Active |
| SensiCare | 71-MSG1090 | FDA UDI | Class I | Active |
| Protexis | 71-CR3DP65 | FDA UDI | Class I | Active |
| Encore | 71-2018465 | FDA UDI | Class I | Unknown |
| Bosma Enterprises | 10-90701S | FDA UDI | Class I | Unknown |
| Biogel | 71-30475 | FDA UDI | Class I | Active |
| Bosma Enterprises | 10-8020SED | FDA UDI | Class I | Active |
| Bosma Enterprises | 10-8020HAL | FDA UDI | Class I | Active |
| Bosma Enterprises | 72-90600 | FDA UDI | Class I | Unknown |
| Protexis | 71-2D73EB80 | FDA UDI | Class I | Active |
| Bosma Enterprises | 10-8020DCL | FDA UDI | Class I | Active |
| Protexis | 71-CR3DP70 | FDA UDI | Class I | Active |
| Biogel | 71-31080 | FDA UDI | Class I | Active |
| Biogel | 71-ML42185 | FDA UDI | Class I | Active |
| Protexis | 71-CR3ET80 | FDA UDI | Class I | Active |
| Protexis | 71-CR2LS80 | FDA UDI | Class I | Active |
| Bosma Enterprises | 10-8020LEO | FDA UDI | Class I | Active |
| Biogel | 71-30560 | FDA UDI | Class I | Active |
| Biogel | 71-ML41665 | FDA UDI | Class I | Active |
| SensiCare | 71-ME9285 | FDA UDI | Class I | Active |
| Protexis | 71-2D72PT55 | FDA UDI | Class I | Active |
| Biogel | 71-41155 | FDA UDI | Class I | Active |
| Biogel | 71-30470 | FDA UDI | Class I | Active |
| Gammex | 71-AN85775 | FDA UDI | Class I | Active |
| Biogel | 71-41170 | FDA UDI | Class I | Active |
| SensiCare | 71-ME1585 | FDA UDI | Class I | Active |
| Ambu | 10-600177-1 | FDA UDI | Class II | Active |
| SensiCare | 71-ME9670 | FDA UDI | Class I | Active |
| Bosma Enterprises | 71-10401 | FDA UDI | Class I | Unknown |
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