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Promedical Surgical Gown, Models 18-301, 18-401, and 18-501

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091097

by Promedical Products Co., Ltd.

Identifiers

510(k) Number
K091097 FDA 510(k)
FDA Product Code
FYA FDA 510(k)
Models / Variants
18-301 FDA 510(k)
18-401 FDA 510(k)
18-501 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 Promedical Surgical Gown, Models 18-301, 18-401, and 18-501 is a disposable protective garment designed for use in surgical and medical procedures. These gowns provide a barrier against contamination from blood, bodily fluids, and other potentially infectious materials, ensuring compliance with sterile field requirements in operating rooms and clinical settings. Constructed from medical-grade materials, they are intended to minimize the risk of cross-contamination during procedures.

These gowns are supplied as single-use items, adhering to standard sterile packaging for medical textiles. They are classified under FDA product code FYA and were granted a Special 510(k) clearance as substantially equivalent to a predicate device. The models are intended for use in general and plastic surgery settings, with no specific MRI safety considerations noted. Storage should follow manufacturer guidelines for sterile medical textiles to maintain integrity until use.

Frequently asked questions

What are the Promedical Surgical Gown Models 18-301, 18-401, and 18-501 designed for?

These gowns are engineered as disposable protective garments to create a barrier against contamination from blood, bodily fluids, and infectious materials during surgical and medical procedures. They are specifically intended for use in sterile field environments, such as operating rooms and clinical settings, to minimize cross-contamination risks in general and plastic surgery contexts.

How are the Promedical Surgical Gowns supplied and what does this imply?

The gowns are supplied as single-use items in sterile packaging, adhering to standard medical textile sterilization practices. This ensures each gown remains uncontaminated until first use, eliminating the need for reprocessing and reducing infection risks associated with reuse.

Are these gowns reusable or intended for single-use?

These gowns are explicitly designed for single-use only. The sterile packaging and disposable nature prevent reuse, which is critical for maintaining infection control standards in surgical and clinical environments where contamination risks must be minimized.

What materials are used in the construction of these gowns?

The gowns are constructed from medical-grade materials, though the exact composition is not specified in the provided data. These materials are selected to provide effective barrier protection against fluids and contaminants while ensuring comfort and durability for the duration of a surgical procedure.

How should these gowns be stored to maintain sterility?

Storage should follow the manufacturer’s guidelines for sterile medical textiles. This typically involves keeping the gowns in their original sealed packaging, away from direct sunlight, moisture, or extreme temperatures, and ensuring the packaging remains intact until the moment of use to preserve sterility.

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: Promedical Surgical Gown, Models 18-301, 18-401 and 18-501, Promedical Surgical Gown, Models 18-301, 18-401 and 18-501, Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 - Beudamed, PROMEDICAL PRODUCTS CO., LTD. FDA Filings - FDA.report, Promedical Products Co., Ltd. FDA 510(k) Products (2004-2009)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Promedical Products Co., Ltd.

Sources (1)

  • FDA 510(k) K091097 24 fields · synced Oct 5, 2026