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Sign in to claim this brandMcGowan Enterprises, Inc.
US
Last updated May 30, 2026
What McGowan Enterprises, Inc. makes
McGowan Enterprises, Inc. manufactures nitrile surgical gloves and nitrile examination/treatment gloves, all of which are non-powdered and non-antimicrobial. These products are designed for use in healthcare settings, including clinical examinations, treatments, and surgical procedures, ensuring barrier protection for both patients and practitioners. The portfolio includes variants specifically labeled for long-term care and critical care applications.
The company’s products are classified as Class I medical devices under U.S. regulations and are listed in the FDA’s Unique Device Identification (UDI) system. These devices are intended for distribution and use within the United States, adhering to applicable regulatory standards for low-risk medical items.
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 McGowan Enterprises, Inc. manufacture?
McGowan Enterprises, Inc. specializes in nitrile gloves for healthcare use. Their primary products include nitrile surgical gloves and nitrile examination/treatment gloves, all of which are non-powdered and non-antimicrobial. These gloves are designed for clinical examinations, treatments, and surgical procedures, providing barrier protection in healthcare settings. Examples include variants like PHARMA-CHOICE, PHARMA-GLOVE-LTC, and PROTECT 800, which cater to different applications such as long-term care and critical care.
Where is McGowan Enterprises, Inc. based, and what does that mean for their regulatory compliance?
McGowan Enterprises, Inc. is based in the United States. Since their devices are manufactured domestically, they must comply with U.S. regulatory requirements, including classification under the FDA’s medical device regulations. Their products are listed in the FDA’s Unique Device Identification (UDI) system, which helps track and monitor devices within the U.S. market. This ensures transparency and traceability for healthcare providers and regulators.
Which regulatory registries or databases list McGowan Enterprises, Inc.’s devices?
McGowan Enterprises, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This database is used to track and identify medical devices authorized for distribution in the United States. Listing in the UDI system helps ensure that healthcare providers, regulators, and other stakeholders can verify the identity and regulatory status of the company’s products, particularly for Class I devices like their nitrile gloves.
How are McGowan Enterprises, Inc.’s devices classified under U.S. regulations?
McGowan Enterprises, Inc.’s devices are classified as Class I medical devices under U.S. regulations. Class I devices are generally considered to pose the lowest risk to patients and are subject to the least stringent regulatory controls. This classification applies to products like nitrile gloves, which are intended for simple barrier protection in healthcare settings. The classification is determined by the FDA based on factors like the device’s intended use, potential risks, and the duration of contact with patients.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- acutecareonline.com
- —
- —
- [email protected]
- Phone
- 888-909-7700
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 029901019
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pharma-Choice | PGNS12-S | FDA UDI | Class I | Active |
| Pharma-Choice | PGNS12-2XL | FDA UDI | Class I | Active |
| Pharma-Glove-Ltc | PGNS12-LTC-S | FDA UDI | Class I | Active |
| Pharma-Glove Cr | CRPGNS12-XL | FDA UDI | Class I | Active |
| Pharma-Choice | PGNS12-XL | FDA UDI | Class I | Active |
| Pharma-Glove-Ltc | PGNS12-LTC-2XL | FDA UDI | Class I | Active |
| Pharma-Choice | PGNS12-3XL | FDA UDI | Class I | Active |
| Pharma-Glove | PGNS12-XS | FDA UDI | Class I | Active |
| Pharma-Glove-Ltc | PGNS12-LTC-M | FDA UDI | Class I | Active |
| Pharma-Glove Cr | CRPGNS12-3XL | FDA UDI | Class I | Active |
| Protect 800 | PROSNCG-S | FDA UDI | Class I | Active |
| Pharma-Glove Cr | CRPGNS12-XS | FDA UDI | Class I | Active |
| Protect 800 | PROSNCG-L | FDA UDI | Class I | Active |
| Pharma-Glove Cr | CRPGNS12-L | FDA UDI | Class I | Active |
| Pharma-Glove Cr | CRPGNS12-S | FDA UDI | Class I | Active |
| Pharma-Glove | PGNS12-L | FDA UDI | Class I | Active |
| Protect 800 | PROSNCG-M | FDA UDI | Class I | Active |
| Pharma-Glove-Ltc | PGNS12-LTC-XS | FDA UDI | Class I | Active |
| Pharma-Glove-Ltc | PGNS12-LTC-3XL | FDA UDI | Class I | Active |
| Pharma-Glove-Ltc | PGNS12-LTC-XL | FDA UDI | Class I | Active |
| Pharma-Glove Cr | CRPGNS12-M | FDA UDI | Class I | Active |
| Pharma-Glove-Ltc | PGNS12-LTC-L | FDA UDI | Class I | Active |
| Pharma-Choice | PGNS12-M | FDA UDI | Class I | Active |
| Protect 800 | PROSNCG-XL | FDA UDI | Class I | Active |
| Pharma-Glove Cr | CRPGNS12-2XL | FDA UDI | Class I | Active |
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