Bio-Shield CSR Wrap

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

510(k) Number

K770933 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Orthopedic Stockinette

  Class I

  FDA 510(k) K770346 Active Cleared 7 Mar 1977

• Drape Packs, Surgical Gowns

  Class II

  FDA 510(k) K790234 Active Cleared 22 Feb 1979

• Mask, Surgical

  Class II

  FDA 510(k) K780169 Active Cleared 13 Feb 1978

• Pediatrics Gown

  Class II

  FDA 510(k) K771929 Active Cleared 16 Nov 1977

• Surgical Gowns and Drapes

  Class II

  FDA 510(k) K781099 Active Cleared 14 Aug 1978

• Surg-O-Pak Prep Pad

  Class II

  FDA 510(k) K781534 Active Cleared 24 Oct 1978

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• What sizes are available for the Bio-Shield CSR Wrap, and how might this affect my choice for different medical instruments or supplies?

  The Bio-Shield CSR Wrap comes in two standard sizes: 15 x 15 inches (38.1 x 38.1 cm) and 36 x 36 inches. The smaller size is ideal for wrapping individual instruments or smaller trays, while the larger size accommodates bulkier items or multiple instruments at once. Choosing the right size ensures proper coverage and sterility without excessive material waste or difficulty in handling.

• Is the Bio-Shield CSR Wrap intended for reuse, or is it meant to be used only once?

  The Bio-Shield CSR Wrap is explicitly designed for single-use applications. This is a standard practice for sterilization wraps to prevent cross-contamination between sterilization cycles and ensure consistent sterility for each use. Reusing it could compromise the integrity of the barrier and the sterility of the wrapped items.

• How should I store the Bio-Shield CSR Wrap before use to maintain its effectiveness?

  While the packaging details aren’t specified, sterilization wraps like the Bio-Shield CSR Wrap should generally be stored in a clean, dry, and protected environment away from direct sunlight, moisture, or extreme temperatures. This preserves the material’s integrity and ensures it remains free of contaminants before use. Always check the packaging for any manufacturer-specific storage instructions.

• Can this wrap be used with any sterilization method, or are there specific processes it’s designed for?

  The Bio-Shield CSR Wrap is intended for use with traditional sterilization methods, such as autoclaving or ethylene oxide (EtO) sterilization, as indicated by its FDA 510(k) classification. It provides a protective barrier during these processes to maintain sterility of the wrapped items. It is not labeled for MRI-safe use or alternative sterilization techniques.