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Healthcare and visitor isolation gown · ST-021

Worn by healthcare personnel or visitors to provide a barrier during patient contact and reduce transfer of infectious material.

Project record

Case reference
ST-021
Target market
Australia
Product class
MD Class I
Our team's work
Submitted on behalf of clients
Evidence basis
Retained certificate, 1 page

What similar projects should consider

Isolation gowns and respiratory protective products may look similar but still require separate determinations of intended use and registration entries.

Individual products still require assessment of intended use, model scope and technical documentation. This case does not replace product-specific classification.

Certificate preview

Grey areas conceal manufacturer and client information. The document below contains all pages with text and images redacted.

Open the complete redacted certificate (PDF · 1 page)Healthcare and visitor isolation gown · ST-021: redacted certificate first page

Discuss your product registration project

Provide intended use, existing authorizations and launch plans so we can assess preparation and support needs.