← Back to catalogue

Primagard Isolation Gown (AAMI PB70 Level 3)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160361

by Primed Medical Products Inc.

Identifiers

510(k) Number
K160361 FDA 510(k)
FDA Product Code
FYC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Primagard Isolation Gown (AAMI PB70 Level 3) is a protective isolation gown classified under AAMI PB70 Level 3 standards. It is designed as a barrier against liquid penetration and contamination, providing enhanced protection for healthcare workers and patients in settings where exposure to bodily fluids and microorganisms is a risk.

This gown is intended for single-use in clinical environments such as hospitals, surgical suites, and other healthcare facilities. It is supplied sterile and adheres to regulatory standards including FDA 510K clearance and MDR compliance. The product is categorized under device class II and is regulated under regulation number 878.4040.

Frequently asked questions

What protection level does the Primagard Isolation Gown provide, and why is this important in healthcare settings?

The Primagard Isolation Gown is designed to meet AAMI PB70 Level 3 standards, offering enhanced barrier protection against liquid penetration and contamination. This level of protection is critical in healthcare settings where exposure to bodily fluids, bloodborne pathogens, or airborne microorganisms is a risk, such as during surgical procedures, patient isolation, or handling infectious materials. The gown’s construction ensures a higher resistance to fluid splash and sprays, reducing the risk of cross-contamination for both healthcare workers and patients.

Is the Primagard Isolation Gown intended for single-use or can it be reused? How does this affect its sterility?

The Primagard Isolation Gown is explicitly designed for single-use only. This is a key feature to ensure patient and clinician safety, as reuse could compromise sterility and integrity, potentially increasing the risk of infection. Since it is supplied sterile, it must remain unopened and unused until the moment of application to maintain its sterile field. Discarding after one use aligns with infection control best practices in clinical environments.

What regulatory pathways has the Primagard Isolation Gown undergone, and how does this impact its use in clinical settings?

The Primagard Isolation Gown has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming its adherence to stringent safety and performance standards. These pathways ensure the gown meets established requirements for protective barriers in healthcare settings, validating its suitability for use in hospitals, surgical suites, and other clinical environments where contamination risks are present. The clearance also reflects third-party validation of its design and manufacturing processes.

Are there multiple sizes or models available for the Primagard Isolation Gown, and how would a clinician determine the appropriate fit?

While the provided data does not specify exact size ranges or model variations (e.g., adult, pediatric, or extended-length options), the Primagard Isolation Gown is categorized under FDA product code FYC (Isolation Gowns) and includes multiple FEI numbers, indicating multiple registered variants. Clinicians should refer to the manufacturer’s sizing guidelines or packaging to select the appropriate size based on patient or wearer dimensions. Proper fit is essential to ensure full coverage and effectiveness as a barrier against contamination.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PRIMAGARD Isolation Gown (AAMI PB70 Level 3), Gowns | Gowns & Apparel | PRIMED Medical Products, Inc., Gowns & Apparel - Products | PRIMED Medical Products, Inc.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Primed Medical Products Inc.
FDA Applicant
Primed Medical Products, Inc.

Sources (2)

  • FDA 510(k) K160361 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 18, 2026