Question 1

What types of medical devices does Imperial Bag & Paper Co. LLC manufacture?

Accepted Answer

Imperial Bag & Paper Co. LLC specializes in manufacturing nitrile and vinyl examination and treatment gloves for medical use. The nitrile gloves are produced in non-powdered and non-antimicrobial formulations, while the vinyl gloves are also non-powdered. These gloves are designed to provide barrier protection during medical procedures and patient care.

Question 2

Where is Imperial Bag & Paper Co. LLC based?

Accepted Answer

Imperial Bag & Paper Co. LLC is based in the United States. The company operates under the US regulatory framework, which governs the manufacturing and distribution of its medical devices.

Question 3

Which regulatory registries list Imperial Bag & Paper Co. LLC’s devices?

Accepted Answer

Imperial Bag & Paper Co. LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring traceability and compliance with regulatory requirements.

Question 4

How are Imperial Bag & Paper Co. LLC’s devices classified by the FDA?

Accepted Answer

Imperial Bag & Paper Co. LLC’s devices fall under FDA’s Class I medical device classification. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as examination and treatment gloves, which are subject to general controls rather than specific regulatory pre-market approvals.

Device	Model / Reference	Registries	Class	Status
Victoria Bay	VBG2N5SB	FDA UDI	Class I	Active
Torq	GLOVES-L	FDA UDI	Class I	Unknown
Torq	HDGLOVES-XL	FDA UDI	Class I	Unknown
Victoria Bay	VBGLN2FXLL	FDA UDI	Class I	Active
Victoria Bay	VB-VY-CL	FDA UDI	Class I	Active
Torq	HDGLOVES-M	FDA UDI	Class I	Unknown
Victoria Bay	VBG2N3M2L	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BK	FDA UDI	Class I	Active
Victoria Bay	VB-VY-CL	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BK	FDA UDI	Class I	Active
Victoria Bay	VBG2N5SL	FDA UDI	Class I	Active
Victoria Bay	VBGLN245FLL	FDA UDI	Class I	Active
Torq	GLOVES-XXL	FDA UDI	Class I	Unknown
Victoria Bay	VBGLN2FSL	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BU	FDA UDI	Class I	Active
Victoria Bay	VBG2N5LL	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BU	FDA UDI	Class I	Active
Victoria Bay	VBG2N5XLB	FDA UDI	Class I	Active
Victoria Bay	VBGLN2FML	FDA UDI	Class I	Active
Torq	GLOVES-S	FDA UDI	Class I	Unknown
Victoria Bay	VBGLN245FSL	FDA UDI	Class I	Active
Victoria Bay	VBG2N5MB	FDA UDI	Class I	Active
Victoria Bay	VBG2N3S2L	FDA UDI	Class I	Active
Victoria Bay	VBG2N5LB	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BK	FDA UDI	Class I	Active
Victoria Bay	VBG2N3L2L	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BK	FDA UDI	Class I	Active
Victoria Bay	VBG2N3XL2L	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BU	FDA UDI	Class I	Active
Victoria Bay	VBG2N5ML	FDA UDI	Class I	Active
Victoria Bay	VBG2N5XLL	FDA UDI	Class I	Active
Torq	GLOVES-XL	FDA UDI	Class I	Unknown
Victoria Bay	VBGLN2FLL	FDA UDI	Class I	Active
Victoria Bay	VB-VY-CL	FDA UDI	Class I	Active
Torq	HDGLOVES-XXL	FDA UDI	Class I	Unknown
Victoria Bay	VBGLN245FML	FDA UDI	Class I	Active
Torq	HDGLOVES-L	FDA UDI	Class I	Unknown
Torq	GLOVES-M	FDA UDI	Class I	Unknown
Victoria Bay	VBGLN245FXLL	FDA UDI	Class I	Active
Victoria Bay	VB-NT-BU	FDA UDI	Class I	Active

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