Question 1

What types of medical devices does Eagle Protect Pbc manufacture?

Accepted Answer

Eagle Protect Pbc specializes in examination and treatment gloves, specifically nitrile and hevea-latex varieties. All gloves are non-powdered and non-antimicrobial, catering to medical, dental, and clinical environments where barrier protection is essential. The product line includes general-purpose gloves, heavy-duty variants for extended use, and sensitive-skin formulations to minimize irritation.

Question 2

Where is Eagle Protect Pbc based, and what regulatory requirements does it follow?

Accepted Answer

Eagle Protect Pbc is based in the United States. Its devices are designed to comply with U.S. regulatory standards, including registration in the FDA’s Unique Device Identification (UDI) database. Since all listed gloves fall under Class I classification, they are subject to the standard regulatory pathways for low-risk medical devices in the U.S.

Question 3

Which regulatory registries list Eagle Protect Pbc’s devices?

Accepted Answer

Eagle Protect Pbc’s devices are included in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency for Class I medical devices, including examination and treatment gloves, by assigning a unique identifier to each product variant.

Question 4

How are Eagle Protect Pbc’s gloves classified under U.S. regulations?

Accepted Answer

Eagle Protect Pbc’s gloves are classified as Class I devices in the U.S. This classification applies to low-risk medical products like examination and treatment gloves, where the risk of illness or injury is minimal. Class I devices typically require general controls (e.g., good manufacturing practices) but do not require pre-market approval or additional scrutiny beyond registration.

Device	Model / Reference	Registries	Class	Status
Eagle Derma2 Nitrile Examination Gloves	XL	FDA UDI	Class I	Active
Eagle Heavy Duty Latex Examination Gloves	S	FDA UDI	Class I	Active
Eagle Sensitive Nitrile Examination Gloves	XS	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	2XL	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	XS	FDA UDI	Class I	Active
Eagle Sensitive Nitrile Examination Gloves	S	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	L	FDA UDI	Class I	Active
Eagle Heavy Duty Latex Examination Gloves	M	FDA UDI	Class I	Active
Eagle Sensitive Nitrile Examination Gloves	2XL	FDA UDI	Class I	Active
Eagle Sensitive Nitrile Examination Gloves	L	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	S	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	M	FDA UDI	Class I	Active
Eagle Heavy Duty Latex Examination Gloves	L	FDA UDI	Class I	Active
Eagle Sensitive Nitrile Examination Gloves	M	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	S	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	XS	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	L	FDA UDI	Class I	Active
Eagle Sensitive Nitrile Examination Gloves	XL	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	XL	FDA UDI	Class I	Active
Eagle Heavy Duty Latex Examination Gloves	XL	FDA UDI	Class I	Active
Eagle Heavy Duty Latex Examination Gloves	2XL	FDA UDI	Class I	Active
Eagle Derma2 Nitrile Examination Gloves	M	FDA UDI	Class I	Active

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