Question 1

What types of medical devices does Relda, LLC manufacture?

Accepted Answer

Relda, LLC specializes in single-use examination and treatment gloves for medical and clinical use. Their products include nitrile, hevea latex, and vinyl gloves, all of which are non-powdered and non-antimicrobial. These gloves are designed to meet the needs of healthcare professionals during procedures and patient care.

Question 2

Where is Relda, LLC based?

Accepted Answer

Relda, LLC is based in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction for medical device oversight.

Question 3

Which regulatory registries list Relda, LLC’s devices?

Accepted Answer

Relda, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify product details and compliance information.

Question 4

How are Relda, LLC’s gloves classified by the FDA?

Accepted Answer

Relda, LLC’s gloves fall under FDA Class I medical devices. This classification applies to products considered low-risk, where general controls are sufficient to ensure safety and effectiveness. Examples include their Dermatec-branded gloves, which are designed for routine medical examinations and treatments.

Device	Model / Reference	Registries	Class	Status
Dermatec Bronze Star	GL602PFB	FDA UDI	Class I	Active
Dermatec Blue Nitrile PF	GL+600NITRILE	FDA UDI	Class I	Active
Dermatec Viper Latex	GL+603BLACKPF	FDA UDI	Class I	Active
Dermatec Viper Nitrile	GL+603VIPERNPF	FDA UDI	Class I	Active
Dermatec Viper Latex	GL+602BLACKPF	FDA UDI	Class I	Active
Dermatec Gold Star	GL500PF	FDA UDI	Class I	Active
Dermatec Gold Star	GL601PF	FDA UDI	Class I	Active
Dermatec Gold Star	GL602PF	FDA UDI	Class I	Active
Dermatec Bronze Star	GL601PFB	FDA UDI	Class I	Active
Dermatec Vinyl	GL+500VINPF	FDA UDI	Class I	Active
Dermatec Viper Nitrile	GL+602VIPERNPF	FDA UDI	Class I	Active
Dermatec Blue Nitrile PF	GL+602NITRILE	FDA UDI	Class I	Active
Dermatec White Nitrile	GL+603WHITENBR	FDA UDI	Class I	Active
Dermatec Blue Nitrile PF	GL+500NITRILE	FDA UDI	Class I	Active
Dermatec Twilight	GL+601STNITRILE	FDA UDI	Class I	Active
Dermatec Viper Latex	GL+601BLACKPF	FDA UDI	Class I	Active
Dermatec Viper Nitrile	GL+600VIPERNPF	FDA UDI	Class I	Active
Dermatec White Nitrile	GL+500WHITENBR	FDA UDI	Class I	Active
Dermatec Gold Star	GL603PF	FDA UDI	Class I	Active
Dermatec Vinyl	GL+600VINPF	FDA UDI	Class I	Active
Dermatec Blue Nitrile PF	GL+603NITRILE	FDA UDI	Class I	Active
Dermatec Viper Latex	GL+500BLACKPF	FDA UDI	Class I	Active
Dermatec Bronze Star	GL600PFB	FDA UDI	Class I	Active
Dermatec White Nitrile	GL+600WHITENBR	FDA UDI	Class I	Active
Dermatec Twilight	GL+600STNITRILE	FDA UDI	Class I	Active
Dermatec Twilight	GL+602STNITRILE	FDA UDI	Class I	Active
Dermatec Gold Star	GL600PF	FDA UDI	Class I	Active
Dermatec Bronze Star	GL603PFB	FDA UDI	Class I	Active
Dermatec Vinyl	GL+602VINPF	FDA UDI	Class I	Active
Dermatec Twilight	GL+603STNITRILE	FDA UDI	Class I	Active
Dermatec White Nitrile	GL+601WHITENBR	FDA UDI	Class I	Active
Dermatec Vinyl	GL+601VINPF	FDA UDI	Class I	Active
Dermatec Bronze Star	GL500PFB	FDA UDI	Class I	Active
Dermatec Blue Nitrile PF	GL+601NITRILE	FDA UDI	Class I	Active
Dermatec Viper Nitrile	GL+601VIPERNPF	FDA UDI	Class I	Active
Dermatec Vinyl	GL+603VINPF	FDA UDI	Class I	Active
Dermatec Twilight	GL+500STNITRILE	FDA UDI	Class I	Active
Dermatec Viper Latex	GL+600BLACKPF	FDA UDI	Class I	Active
Dermatec White Nitrile	GL+602WHITENBR	FDA UDI	Class I	Active
Dermatec Viper Nitrile	GL+500VIPERNPF	FDA UDI	Class I	Active

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