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EMM High Performance Surgical Gown with AAMI Liquid Barrier Level IV

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K120045

by Exact Medical Manufacturing, Inc

Identifiers

510(k) Number
K120045 FDA 510(k)
FDA Product Code
FYA 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)

This device is a surgical gown designed to provide a high-performance barrier against liquid penetration, classified under AAMI Liquid Barrier Level IV standards. It is engineered to enhance protection for both patients and healthcare providers during surgical procedures, ensuring durability and fluid resistance where contamination risks are highest.

The gown is supplied as a single-use item, intended for use in sterile surgical environments. It adheres to FDA 510(k) clearance (K120045) and MDR requirements, ensuring compliance with regulatory standards for surgical attire. Available in standard sizes, it must be stored in a clean, dry environment to maintain sterility and integrity before use.

Frequently asked questions

What makes this surgical gown suitable for high-risk contamination environments like surgical procedures?

This gown is designed with an AAMI Liquid Barrier Level IV standard, which provides the highest level of protection against liquid penetration. This classification ensures it meets stringent requirements for fluid resistance, making it ideal for surgical settings where contamination risks are elevated. The material is engineered to maintain durability and barrier integrity during procedures.

Is this gown intended for reuse, or is it meant to be used only once?

This gown is explicitly labeled as a single-use item, meaning it should not be reused after a single surgical procedure. Single-use design ensures patient and clinician safety by preventing cross-contamination and maintaining sterility standards.

How should I store this gown to keep it sterile and intact before use?

The gown must be stored in a clean, dry environment to preserve its sterility and structural integrity. Avoid exposure to moisture, direct sunlight, or extreme temperatures, as these conditions can compromise the material’s barrier properties and packaging.

What regulatory pathways does this gown follow, and how does that affect its use?

This gown follows FDA 510(k) clearance (K120045) and MDR (Medical Device Regulation) compliance, confirming it meets U.S. and EU safety and performance standards. These pathways ensure the gown’s design and manufacturing align with regulatory expectations for surgical attire, but they do not dictate clinical indications—only that it’s suitable for sterile surgical environments as described.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Exact Medical Manufacturing, Inc
FDA Applicant
Exact Medical Manufacturing, Inc.

Sources (2)

  • FDA 510(k) K120045 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026