Disposable Sterile Syringe, with/without needle - Disposable Sterile Syringe, with/without needle

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

510(k) Number

K212033 ↗

FDA Product Code

FMF

Models / Variants

Disposable Sterile Syringe, with/without needle

luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

FDA applicant

Shandong Zhushi Pharmaceutical Group Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Disposable Nitrile Examination Gloves

  Class I

  FDA 510(k) K203436 Active Cleared 28 Apr 2021

• Disposable Surgical Gown

  Class II

  FDA 510(k) K210510 Active Cleared 12 Aug 2021

• Disposable infusion set with needle

  Class II

  FDA 510(k) K232475 Active Cleared 10 May 2024

• Infrared Thermometer

  Class II

  FDA 510(k) K203454 Active Cleared 29 Apr 2021

• Disposable Vinyl Examination Gloves

  Class I

  FDA 510(k) K203439 Active Cleared 26 Feb 2021

• Disposable Surgical Face Mask

  Class I

  FDA 510(k) ×2 K210409 Active Cleared 28 Jul 2021 CE/MDR

See all devices from Shandong Zhushi Pharmaceutical Group Co., Ltd →

• What is the purpose of the Disposable Sterile Syringe?

  The Disposable Sterile Syringe is designed for medical procedures requiring precise fluid delivery, specifically for insulin administration or hypodermic injections. It features luer or luer-lock connections for secure attachment to needles or other medical devices.

• Is this syringe reusable or single-use only?

  This syringe is designed for single-use only. It is supplied in a sterile condition and should not be reused to ensure patient safety and prevent contamination or infection.

• What sizes and models are available for this syringe?

  The syringe is available in various sizes as specified by the model numbers. The specific sizes and model options should be confirmed with the manufacturer based on the intended use and requirements.

• What is the regulatory status of this syringe?

  The Disposable Sterile Syringe has received FDA 510(k) clearance with product code FMF. It was determined to be substantially equivalent, with authorization received on 2022-08-17.