CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES

K955772 · Ttk Biomed, Ltd. · FMI · Jul 8, 1996 · General Hospital

Device Facts

• Record ID: K955772
• Device Name: CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
• Applicant: Ttk Biomed, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Jul 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.

Device Story

Sterile disposable syringes and needles for general purpose injections. Device components: polypropylene barrels, thin-walled SS304 stainless steel capillary needles, natural rubber gaskets. Barrels lubricated with Polydimethyl Silicone. Used in clinical settings by healthcare professionals for medication administration or fluid aspiration. Single-use, disposable design.

Clinical Evidence

Bench testing only; compliance with ISO 7886, ISO 7864, ISO 594, ISO 9626, and ISO 6009 standards.

Technological Characteristics

Materials: Polypropylene (barrel), SS304 stainless steel (needle tubing), natural rubber (gasket). Lubricant: Polydimethyl Silicone. Standards: ISO 7886 (syringes), ISO 7864 (needles), ISO 594 (Luer fittings), ISO 9626 (tubing), ISO 6009 (needles). Single-use, sterile, disposable.

Indications for Use

Indicated for general purpose injections in patients requiring hypodermic administration of medication or fluid withdrawal.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Sterile Disposable Syringe (Becton, Dickinson & Company)
• Sterile Disposable Syringes and Needles (Becton, Dickinson & Company)
• Sterile Disposable Hypodermic Needle (Becton, Dickinson & Company)

Submission Summary (Full Text)

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K955772
JUL - 8 1996
TTK Biomed
LIMITED
H-12-13, M1DC, Industrial Area, Waliuj, Auranganaad - 47.136
Telephone: 54037, Fax: 55189

# 510(k) Summary
## Clinicare
### Sterile Disposable Syringes
### Sterile Disposable Syringes With Needles
### Sterile Disposable Needles

I. General Information on Submitter:

- Name: TTK Biomed Limited
- Address: H-12-13, M1DC, Industrial Area, Waluj, India 431 136
- Telephone: 54037
- Fax: 55189
- Name of Contact Person:
- Date Summary Prepared:

II. General Information on Device

- Name: Clinicare Sterile Disposable Syringe
- Clinicare Sterile Disposable Syringes and Needles
- Clinicare Sterile Disposable Hypodermic Needles

- Common Name: Sterile Disposable Syringe
- Sterile Disposable Syringes and Needles
- Sterile Disposable Hypodermic Needle

- Classification Name: Piston Syringes
- Hypodermic Single Lumen Needle

III. Predicate Devices:

- Sterile Disposable Syringe
- Sterile Disposable Syringes and Needles
- Sterile Disposable Hypodermic Needle
- Becton, Dickinson & Company

IV. Description of Device:

The Clinicare Needles and Syringes comply with: ISO 7886, Sterile Hypodermic Syringes for Single Use; ISO 7864, Sterile Hypodermic Needles for Single Use; ISO 594, Conical Fitting with a 6% (Luer) Paper for Syringes, Needles and Certain Other Equipment; ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices; and, ISO 6009, Hypodermic Needles for Single Use.

A Group Company

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The sterile disposable syringes are made with polypropylene. The needles are made from thin walled SS304 capillary tubes. The rubber gaskets are made from natural rubber. The barrels are lubricated with Polydimethyl Silicone.

V. Intended Use: The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.

VI. Technological Characteristics of Device Compared to Predicate Device: None.

VII. Tests for Substantial Equivalence: None.