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Perval Surgical Gown (marketing Name)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K950504

by Standard Textile Co., Inc.

Identifiers

510(k) Number
K950504 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 Perval Surgical Gown 75665134 is a disposable surgical gown designed for use in sterile surgical procedures. It provides barrier protection for healthcare personnel and patients against contamination from blood, bodily fluids, and microorganisms during surgical interventions. Constructed to meet regulatory standards for surgical attire, it ensures compliance with infection control protocols in operating rooms and clinical settings.

This gown is supplied in a sterile, single-use package and is intended for use in general surgical procedures. It is classified under FDA product code FYA and holds a 510(k) clearance (K950504) for substantial equivalence. The gown is available in a specific size designation (CEIL XL) and must be stored in a clean, dry environment to maintain sterility. No MRI safety or reusable specifications are indicated in the regulatory data.

Frequently asked questions

What is the Perval Surgical Gown 75665134 used for?

The Perval Surgical Gown 75665134 is designed to provide barrier protection for healthcare personnel and patients during sterile surgical procedures. It shields against contamination from blood, bodily fluids, and microorganisms, ensuring compliance with infection control protocols in operating rooms and clinical settings.

Is the gown sterile and single-use?

Yes, the gown is supplied in a sterile, single-use package. This ensures that each gown is uncontaminated and intended for one-time use only, reducing the risk of cross-contamination between patients or procedures.

What size is available for the Perval Surgical Gown 75665134?

This gown is available in the CEIL XL size designation. The size is specified to accommodate larger patients, ensuring proper coverage and protection during surgical procedures.

How should the gown be stored to maintain sterility?

The gown must be stored in a clean, dry environment to preserve its sterility. Proper storage conditions prevent moisture, dust, or contamination that could compromise the gown’s protective integrity before use.

Can this gown be reused?

No, the Perval Surgical Gown 75665134 is explicitly designed for single-use only. Reusing it violates infection control standards and could expose patients and staff to contamination risks.

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: PERVAL SURGICAL GOWN (MARKETING NAME) - Innolitics, STANDARD TEXTILE CO., INC. 75665134 Perval Surgical Gown, Perval Surgical Gown - BEUDAMED, Perval Surgical Gown 75665135 OR GWN PERVAL PLUS… - FDA.report, PerVal® Surgical Towels | 100% Cotton Surgical Towels | Standard Textile

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Standard Textile Co., Inc.

Sources (1)

  • FDA 510(k) K950504 24 fields · synced Oct 1, 2026