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Maxima Surgical Gown

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201351

by Elevate Textiles

Identifiers

510(k) Number
K201351 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)

The Maxima Surgical Gown is a protective garment classified as a surgical gown under product code FYA, designed to provide barrier protection during surgical procedures. It is intended for use by healthcare professionals to minimize exposure to bodily fluids and contaminants in sterile environments.

This gown is supplied as a single-use disposable item, cleared for use in general and plastic surgery settings under FDA 510(k) clearance (K201351). It follows a traditional review pathway and is intended for sterile applications, adhering to regulatory standards for Class II medical devices. Storage and handling should comply with standard surgical gown protocols to maintain sterility.

Frequently asked questions

What types of surgical procedures is the Maxima Surgical Gown intended for, and how does that affect its use in clinical settings?

The Maxima Surgical Gown is cleared for use in general and plastic surgery settings, as specified under the FDA’s 510(k) clearance (K201351). This means it is designed to provide barrier protection during sterile procedures where exposure to bodily fluids and contaminants is a risk. Clinicians should select this gown for any surgical environment where standard sterile gowning protocols apply, ensuring compliance with the gown’s intended use in those specific procedural contexts.

Is the Maxima Surgical Gown reusable, or is it meant to be used only once? How should it be handled to maintain sterility?

The Maxima Surgical Gown is explicitly single-use and disposable, as stated in its description. To maintain sterility, it should be stored and handled according to standard surgical gown protocols—typically in sealed, sterile packaging until the moment of use. Once opened, the gown should be used immediately and discarded after a single procedure to prevent contamination.

What sizes or models of the Maxima Surgical Gown are available, and how do I determine the correct fit for a clinician?

The provided specifications do not list explicit size variants (e.g., small, medium, large) for the Maxima Surgical Gown. However, like most surgical gowns, it is likely available in standard adult sizes to accommodate most clinicians. To ensure a proper fit, refer to the manufacturer’s sizing guide (available from Elevate Textiles) or consult the gown’s packaging for recommended measurements. If unsure, testing a sample or consulting the gown’s technical data sheet may help confirm compatibility with the user’s body type.

How is the sterility of the Maxima Surgical Gown ensured, and what storage conditions should be followed?

The Maxima Surgical Gown is intended for sterile applications, meaning it is manufactured and packaged under controlled conditions to maintain sterility until use. To preserve sterility, store the gown in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing the packaging to moisture, chemicals, or physical damage, as this could compromise sterility before use.

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: Maxima Surgical Gown - healthcareequipment.org, K201351 FDA 510 (k) - Maxima Surgical Gown | Elevate Textiles, PDF 22 American Street Re: K201351 Trade/Device Name: Maxima Surgical Gown ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Elevate Textiles

Sources (1)

  • FDA 510(k) K201351 24 fields · synced Sep 20, 2026