Question 1

What types of medical devices does Saf-T-Gard International, Inc. manufacture?

Accepted Answer

Saf-T-Gard International, Inc. specializes in nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are primarily designed for medical and clinical use to create a protective barrier between users and patients during procedures.

Question 2

Where is Saf-T-Gard International, Inc. based?

Accepted Answer

The company is headquartered in the United States. This location aligns with regulatory frameworks governing medical device manufacturing and distribution in the region.

Question 3

How are Saf-T-Gard International, Inc.’s devices classified by regulatory authorities?

Accepted Answer

Saf-T-Gard International, Inc.’s nitrile gloves fall under FDA Class I medical devices. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as single-use protective barriers like gloves.

Question 4

Are Saf-T-Gard International, Inc.’s devices listed in any regulatory registries?

Accepted Answer

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices through standardized identifiers, ensuring traceability and compliance with regulatory requirements.

Device	Model / Reference	Registries	Class	Status
Ambi-Gard	8670/L	FDA UDI	Class I	Active
Ambi-Gard	8670/XL	FDA UDI	Class I	Active
Ambi-Gard	8670/XS	FDA UDI	Class I	Active
Ambi-Gard	8670/M	FDA UDI	Class I	Active
Ambi-Gard	8670/S	FDA UDI	Class I	Active
Ambi-Gard	8670/2XL	FDA UDI	Class I	Active

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