Disp. Fenestrated Surg. Drape Sheets

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K802359 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Tomac Sterile Disp. Lap Sponge

  Class I

  FDA 510(k) K812554 Active Cleared 24 Sep 1981

• Antimicrobial Incise Drape

  Class II

  FDA 510(k) K840957 Active Cleared 7 Jun 1984

• Disimetric Release of Instranetics Rad

  Class I

  FDA 510(k) K830786 Active Cleared 18 May 1983

• Shield Lucky Cap; Blossom Bouffant Cap

  Class I

  FDA 510(k) K800511 Active Cleared 16 Apr 1980

• Tackmer Incise Drape

  Class II

  FDA 510(k) K802050 Active Cleared 16 Sep 1980

• Convertors Sterile Disp. Lap Sponge II

  Unclassified

  FDA 510(k) K813296 Active Cleared 29 Dec 1981

See all devices from American Convertors Div., American Pharmaseal →

• What are the fenestrated surgical drape sheets used for?

  These drapes are designed to isolate and protect the surgical field during operative procedures. The fenestrations (cut-out openings) allow surgical instruments, limbs, or anatomical landmarks to pass through while maintaining a sterile barrier. This ensures a clean workspace and prevents contamination, which is critical for patient safety and procedural success.

• Are the fenestrated surgical drape sheets reusable or single-use?

  The fenestrated surgical drape sheets are explicitly intended for single-use only. They are supplied in sterile packaging to ensure contamination control during procedures. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

• How are these drapes supplied, and what does the packaging ensure?

  The drapes are supplied in sterile packaging, which maintains their sterility until use. The packaging is designed to protect the drapes from contamination, ensuring they remain uncontaminated until opened in a sterile field. This is essential for maintaining surgical site integrity during procedures.

• What sizes or models of fenestrated surgical drape sheets are available?

  The provided data does not specify exact sizes or model variations beyond the general description of 'fenestrated surgical drape sheets.' For precise dimensions or model-specific details, refer to the manufacturer’s product catalog or technical specifications. Typically, such drapes come in standard sizes to accommodate common surgical needs, but custom fenestrations may vary.

• How should these drapes be stored before use?

  The drapes should be stored in their original sterile packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure the packaging remains intact until use to preserve sterility. Avoid storing them in areas prone to moisture, dust, or chemical exposure, as these could compromise the drape’s integrity.