Isolation Gown

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780605 ↗

FDA Product Code

FYC

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K862112 Active Cleared 13 Jun 1986

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  Class II

  FDA 510(k) K832329 Active Cleared 24 Aug 1983

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  FDA 510(k) K841678 Active Cleared 19 Jul 1984

• Instrument Lubricant

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  FDA 510(k) K780610 Active Cleared 31 May 1978

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  FDA 510(k) K800236 Active Cleared 22 Feb 1980

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• What is the Isolation Gown designed to protect against in clinical settings?

  The Isolation Gown is a protective barrier intended to shield healthcare personnel and patients from bodily fluids, pathogens, and environmental contaminants. Its primary purpose is to maintain infection control and reduce the risk of cross-transmission during medical procedures or patient care, particularly in general and plastic surgery environments.

• Is the Isolation Gown reusable or single-use?

  The Isolation Gown is supplied as a single-use, disposable item. This design ensures hygiene and reduces the risk of contamination between uses, aligning with infection control best practices in clinical settings.

• What type of sterility does the Isolation Gown have?

  The Isolation Gown is explicitly labeled as non-sterile. Non-sterile gowns are appropriate for general infection control measures where a sterile barrier is not required, such as in routine patient care or non-invasive procedures.

• How should the Isolation Gown be stored before use?

  The Isolation Gown must be stored in a clean, dry environment to preserve its integrity until use. Proper storage conditions help maintain the gown’s protective properties and prevent contamination or degradation before deployment in clinical settings.

• What regulatory pathway does the Isolation Gown follow?

  The Isolation Gown is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K780605. It falls under FDA product code FYC (surgical and isolation gowns) and regulation number 878.4040, ensuring compliance with U.S. medical device standards for infection control barriers.