Monoject Snap-Over Safety Cap

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

Full name

Monoject(R) Snap-Over Safety Cap

510(k) Number

K882614 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Argyle Vac-U-Care 100cc Suct. Reservoir

  Class I

  FDA 510(k) K801372 Active Cleared 26 Jun 1980

• Argyle Aspr-Care Closed Suction System

  Class I

  FDA 510(k) K934723 Active Cleared 30 Nov 1993

• Labcer Fibrinogen Assay Kit & Calibr.

  Class II

  FDA 510(k) K812570 Active Cleared 2 Oct 1981

• Monoject(R) Trace Element Blood Collection Tube

  Class II

  FDA 510(k) K883320 Active Cleared 27 Sep 1988

• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

  Class I

  FDA 510(k) K933510 Active Cleared 24 Feb 1994

See all devices from Sherwood Medical Co. →

• What types of medical containers or devices is the Monoject Snap-Over Safety Cap designed to secure and seal?

  The Monoject Snap-Over Safety Cap is specifically designed to secure and seal the openings of intravenous (IV) containers, syringes, and other medical fluid reservoirs. Its snap-over style ensures a secure fit on standard IV containers and syringes, providing a barrier to prevent contamination and accidental exposure during handling and transport.

• Is the Monoject Snap-Over Safety Cap intended for reuse, or is it meant to be used only once?

  The Monoject Snap-Over Safety Cap is explicitly intended for single-use only. This design choice helps maintain sterility and reduce the risk of contamination or cross-exposure between patients or procedures.

• How is the Monoject Snap-Over Safety Cap supplied, and is it sterile?

  The Monoject Snap-Over Safety Cap is supplied sterile and ready for immediate clinical use. Since it is designed for single-use, sterility is preserved until the cap is first applied, ensuring safety for patients and healthcare providers.

• What clinical setting is this safety cap primarily intended for, and why?

  The Monoject Snap-Over Safety Cap is primarily intended for use in clinical chemistry settings, where precise handling of fluids—such as IV solutions, syringes, or reservoirs—is critical. Its design minimizes contamination risks, which is particularly important in environments where fluid integrity directly impacts diagnostic accuracy or patient safety.

• How does the snap-over design of this safety cap benefit users compared to other types of caps?

  The snap-over design of the Monoject Safety Cap provides a secure, tight seal that is easy to apply and remove without tools, reducing the risk of leaks or accidental spills during transport or handling. This design also ensures a consistent fit across standard IV containers and syringes, improving usability and reliability in clinical workflows.