← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

PRIMARY PRODUCTS COMPANY

US

Last updated May 23, 2026

What PRIMARY PRODUCTS COMPANY makes

The company manufactures single-use medical gloves, including nitrile, vinyl, and latex varieties, all of which are non-powdered and non-antimicrobial. It also produces surgical and medical respirators for single-use, as well as disposable professional examination gowns. The gloves and gowns are designed for examination and treatment procedures, while the respirators are intended for medical use.

The portfolio includes devices classified under FDA’s Class I and Class II categories, with all products listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to applicable regulatory requirements for these device classifications.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does PRIMARY PRODUCTS COMPANY manufacture?

PRIMARY PRODUCTS COMPANY specializes in single-use medical devices primarily focused on personal protective equipment for healthcare settings. Its portfolio includes nitrile, vinyl, and latex examination and treatment gloves (all non-powdered and non-antimicrobial), surgical and medical respirators (single-use, non-antimicrobial), and disposable professional examination gowns. These products are designed for use in examination, treatment, and medical procedures, ensuring compliance with regulatory standards for their respective categories.

Where is PRIMARY PRODUCTS COMPANY based, and how does this affect its devices?

PRIMARY PRODUCTS COMPANY is based in the United States, which means its devices are subject to FDA regulations. The company’s products fall under FDA’s Class I and Class II classifications, reflecting varying levels of regulatory oversight based on risk. Being U.S.-based also ensures alignment with domestic regulatory requirements, including mandatory listing in the FDA’s Unique Device Identification (UDI) system for traceability and compliance tracking.

Which regulatory registries or databases list PRIMARY PRODUCTS COMPANY’s devices?

PRIMARY PRODUCTS COMPANY’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This system assigns a unique identifier to each medical device to improve tracking, transparency, and regulatory compliance. Listing in the UDI system is mandatory for devices regulated by the FDA, ensuring that each product can be traced throughout its lifecycle.

How are PRIMARY PRODUCTS COMPANY’s devices classified by the FDA?

The FDA classifies PRIMARY PRODUCTS COMPANY’s devices into Class I and Class II categories. Class I devices generally pose the lowest risk and often require only general controls (e.g., good manufacturing practices) for compliance. Class II devices involve a higher level of risk and may require special controls like performance standards or post-market surveillance to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
089569581

Catalogue (63)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
PrimaPro 272-45
FDA UDI
Class IActive
PrimaPro 232-45
FDA UDI
Class IActive
PrimaPro 612-45
FDA UDI
Class IActive
PrimaPro 222-45
FDA UDI
Class IActive
PrimaPro 613-45
FDA UDI
Class IActive
PrimaPro 521-45
FDA UDI
Class IActive
PrimaPro 225-45
FDA UDI
Class IActive
PrimaPro 254-45
FDA UDI
Class IActive
PrimaPro 216-45
FDA UDI
Class IActive
PrimaPro PE-3745-XL
FDA UDI
Class IActive
PrimaPro 212-45
FDA UDI
Class IActive
PrimaPro 252-45
FDA UDI
Class IActive
PrimaPro 611-45
FDA UDI
Class IActive
PrimaPro 273-45
FDA UDI
Class IActive
PrimaPro 311-45
FDA UDI
Class IActive
PrimaPro 413-45
FDA UDI
Class IActive
PrimaPro 312-45
FDA UDI
Class IActive
PrimaPro W182028EL-BX
FDA UDI
Class IIActive
PrimaPro 525-45
FDA UDI
Class IActive
PrimaPro 214-45
FDA UDI
Class IActive
PrimaPro 421-45
FDA UDI
Class IActive
PrimaPro 243-45
FDA UDI
Class IActive
PrimaPro 423-45
FDA UDI
Class IActive
PrimaPro 520-45
FDA UDI
Class IActive
PrimaPro 223-45
FDA UDI
Class IActive
PrimaPro 274-45
FDA UDI
Class IActive
PrimaPro 424-45
FDA UDI
Class IActive
PrimaPro 234-45
FDA UDI
Class IActive
PrimaPro 233-45
FDA UDI
Class IActive
PrimaPro 523-45
FDA UDI
Class IActive
PrimaPro 213-45
FDA UDI
Class IActive
PrimaPro B183028EL
FDA UDI
Class IIActive
PrimaPro 412-45
FDA UDI
Class IActive
PrimaPro 313-45
FDA UDI
Class IActive
PrimaPro 220-45
FDA UDI
Class IActive
PrimaPro W182028EL-BG
FDA UDI
Class IIActive
PrimaPro 3XL-PE-GOWN
FDA UDI
Class IActive
PrimaPro 242-45
FDA UDI
Class IActive
PrimaPro 241-45
FDA UDI
Class IActive
PrimaPro 235-45
FDA UDI
Class IActive
PrimaPro 270-45
FDA UDI
Class IActive
PrimaPro 414-45
FDA UDI
Class IActive
PrimaPro 231-45
FDA UDI
Class IActive
PrimaPro 230-45
FDA UDI
Class IActive
PrimaPro Y4959-02-28
FDA UDI
Class IActive
PrimaPro 411-45
FDA UDI
Class IActive
PrimaPro 524-45
FDA UDI
Class IActive
PrimaPro 221-45
FDA UDI
Class IActive
PrimaPro 215-45
FDA UDI
Class IActive
PrimaPro 522-45
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.