CK 1600 Series Towels

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

510(k) Number

K872395 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Currie Medical Specialties, Inc. →

• What are the CK 1600 Series Towels designed for?

  The CK 1600 Series Towels are sterile, disposable surgical drapes engineered to create a protective barrier against contamination during surgical procedures. Their lightweight yet durable plastic construction ensures a clean field in operating rooms and sterile environments, particularly in general and plastic surgery settings, where maintaining aseptic conditions is critical.

• Are these towels reusable or single-use?

  These towels are intended for single-use only. Their sterile packaging and disposable design align with best practices for infection control, ensuring each use provides a fresh, uncontaminated barrier for surgical procedures.

• What materials are the CK 1600 Series Towels made from?

  The towels are constructed from plastic material, which balances durability with lightweight ease of use. This material choice helps maintain flexibility during procedures while providing a reliable barrier against microbial contamination.

• How should these towels be stored?

  While specific storage instructions are not detailed in the provided data, standard practice for sterile, single-use surgical drapes like these includes keeping them in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. This preserves sterility and integrity until use.

• What regulatory pathway was followed for the CK 1600 Series Towels?

  The CK 1600 Series Towels received FDA 510(k) clearance under the Traditional review pathway, with a decision of Substantially Equivalent to a predicate device. This classification falls under FDA product code KKX, confirming their compliance with U.S. regulatory standards for surgical drapes.