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Sign in to claim this brandHOURGLASS INTERNATIONAL INC
US
Last updated May 24, 2026
What HOURGLASS INTERNATIONAL INC makes
Hourglass International Inc manufactures examination and treatment gloves, including nitrile and natural rubber (Hevea-latex) variants that are non-powdered and non-antimicrobial. Their portfolio includes products like Scion, Sable, AirSoft, FreeStyle, Cirrus, and Fortis, designed for medical and procedural use.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 Hourglass International Inc manufacture?
Hourglass International Inc specializes in examination and treatment gloves, offering two primary types: nitrile gloves and Hevea-latex (natural rubber) gloves. Both variants are designed as non-powdered and non-antimicrobial, ensuring compatibility with medical and procedural applications where these properties are required. Examples of their products include Scion, Sable, AirSoft, FreeStyle, Cirrus, and Fortis.
Where is Hourglass International Inc based, and what does this mean for its regulatory oversight?
Hourglass International Inc is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes their products, indicating they are registered and listed under the agency’s requirements for Class I devices, which are generally considered low-risk but still subject to compliance standards.
How are Hourglass International Inc’s gloves classified under FDA regulations?
Hourglass International Inc’s gloves are classified as Class I devices under FDA regulations. This classification applies to products deemed to pose minimal risk to users, such as single-use gloves for examination or treatment. Class I devices typically require less stringent premarket review compared to higher-risk categories, though they must still comply with FDA registration, listing, and labeling requirements.
Which regulatory registries or databases list Hourglass International Inc’s medical devices?
Hourglass International Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain by assigning a unique identifier to each product, including details like brand name, model, and manufacturer. This registry helps healthcare providers, regulators, and distributors verify and track the devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- hourglass-intl.com
- —
- —
- [email protected]
- Phone
- 800-277-0994
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 026777252
Catalogue (130)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Scion | 702 | FDA UDI | Class I | Active |
| Scion | 704 | FDA UDI | Class I | Active |
| Sable | 600-SP | FDA UDI | Class I | Active |
| AirSoft | 902 | FDA UDI | Class I | Active |
| FreeStyle | 1100-SP | FDA UDI | Class I | Active |
| AirSoft | 902 | FDA UDI | Class I | Active |
| Cirrus | 800B | FDA UDI | Class I | Active |
| AirSoft | 900-SP | FDA UDI | Class I | Active |
| Scion | 701-SP | FDA UDI | Class I | Active |
| Cirrus | 801B | FDA UDI | Class I | Active |
| Fortis | 500-SP | FDA UDI | Class I | Active |
| Cirrus | 800B | FDA UDI | Class I | Active |
| AirSoft | 904 | FDA UDI | Class I | Active |
| Scion | 700 | FDA UDI | Class I | Active |
| FreeStyle | 1106 | FDA UDI | Class I | Active |
| Scion | 703-SP | FDA UDI | Class I | Active |
| Scion | 701 | FDA UDI | Class I | Active |
| RoyalTouch | 301-SP | FDA UDI | Class I | Active |
| Scion | 702-SP | FDA UDI | Class I | Active |
| RoyalTouch | 300 | FDA UDI | Class I | Active |
| RoyalTouch | 304 | FDA UDI | Class I | Active |
| FreeStyle | 1103 | FDA UDI | Class I | Active |
| RoyalTouch | 303 | FDA UDI | Class I | Active |
| Scion | 704 | FDA UDI | Class I | Active |
| HandPro 400 | 403-SP | FDA UDI | Class I | Active |
| FreeStyle | 1102 | FDA UDI | Class I | Active |
| Fortis | 501 | FDA UDI | Class I | Active |
| RoyalTouch | 302 | FDA UDI | Class I | Active |
| Cirrus | 803B | FDA UDI | Class I | Active |
| Cirrus | 801B | FDA UDI | Class I | Active |
| RoyalTouch | 304-SP | FDA UDI | Class I | Active |
| Cirrus | 800B | FDA UDI | Class I | Active |
| HandPro 400 | 403 | FDA UDI | Class I | Active |
| AirSoft | 901 | FDA UDI | Class I | Active |
| FreeStyle | 1101 | FDA UDI | Class I | Active |
| Cirrus | 802B | FDA UDI | Class I | Active |
| AirSoft | 901 | FDA UDI | Class I | Active |
| Cirrus | 804B | FDA UDI | Class I | Active |
| RoyalTouch | 300-SP | FDA UDI | Class I | Active |
| RoyalTouch | 302 | FDA UDI | Class I | Active |
| Cirrus | 803B | FDA UDI | Class I | Active |
| FreeStyle | 1102 | FDA UDI | Class I | Active |
| FreeStyle | 1105 | FDA UDI | Class I | Active |
| FreeStyle | 1102 | FDA UDI | Class I | Active |
| RoyalTouch | 303 | FDA UDI | Class I | Active |
| RoyalTouch | 300 | FDA UDI | Class I | Active |
| Scion | 704 | FDA UDI | Class I | Active |
| Fortis | 504-SP | FDA UDI | Class I | Active |
| Fortis | 500 | FDA UDI | Class I | Active |
| Scion | 702 | FDA UDI | Class I | Active |
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