Question 1

What types of medical devices does Hourglass International Inc manufacture?

Accepted Answer

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.

Question 2

Where is Hourglass International Inc based, and what does this mean for its regulatory oversight?

Accepted Answer

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.

Question 3

How are Hourglass International Inc’s gloves classified under FDA regulations?

Accepted Answer

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.

Question 4

Which regulatory registries or databases list Hourglass International Inc’s medical devices?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Sable	603	FDA UDI	Class I	Active
AirSoft	904	FDA UDI	Class I	Active
RoyalTouch	302-SP	FDA UDI	Class I	Active
Fortis	505	FDA UDI	Class I	Active
HandPro 400	400-SP	FDA UDI	Class I	Active
FreeStyle	1104	FDA UDI	Class I	Active
AirSoft	904	FDA UDI	Class I	Active
Scion	703	FDA UDI	Class I	Active
Fortis	502	FDA UDI	Class I	Active
Cirrus	803B	FDA UDI	Class I	Active
Sable	600	FDA UDI	Class I	Active
RoyalTouch	304	FDA UDI	Class I	Active
HandPro 400	400	FDA UDI	Class I	Active
Fortis	503-SP	FDA UDI	Class I	Active
Scion	700-SP	FDA UDI	Class I	Active
Scion	703	FDA UDI	Class I	Active
RoyalTouch	304	FDA UDI	Class I	Active
RoyalTouch	301	FDA UDI	Class I	Active
Fortis	504	FDA UDI	Class I	Active
Scion	701	FDA UDI	Class I	Active
HandPro 400	402-SP	FDA UDI	Class I	Active
Cirrus	804B	FDA UDI	Class I	Active
Scion	704-SP	FDA UDI	Class I	Active
AirSoft	900	FDA UDI	Class I	Active
HandPro 400	404-SP	FDA UDI	Class I	Active
FreeStyle	1103	FDA UDI	Class I	Active
RoyalTouch	302	FDA UDI	Class I	Active
FreeStyle	1105	FDA UDI	Class I	Active
Sable	602	FDA UDI	Class I	Active
RoyalTouch	303	FDA UDI	Class I	Active

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