DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)

K963134 · Igenics, Inc. · EFQ · Sep 6, 1996 · SU

Device Facts

• Record ID: K963134
• Device Name: DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
• Applicant: Igenics, Inc.
• Product Code: EFQ · SU
• Decision Date: Sep 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.

Device Story

Nonwoven synthetic drain/slit sponge; rayon and polyester fibers; slit cut accommodates tubes or needles; used as wound dressing; provides soft, absorbent, low-linting alternative to traditional cotton gauze; reduces wound adhesion; used in medical and dental settings; applied by clinicians.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Rayon and polyester fiber nonwoven synthetic sponge; slit configuration; sterilized via radiation or ethylene oxide; pattern mimics traditional cotton gauze; high absorbency; low linting.

Indications for Use

Indicated for use as a dressing around tubes and needles and for general medical and dental purposes where cotton gauze is traditionally used.

Predicate Devices

• Nu Gauze (Johnson & Johnson Medical, Inc.)
• Versalon (Kendall Co.)

Submission Summary (Full Text)

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SEP - 6 1996
510K SUMMARY
K963134
IGENICS, INC.
3 First Avenue
Peabody, MA 01960

Telephone: [phone]
Facsimile: [phone]

Contact Person: Eduard T. van Breen, President

August 2, 1996

Trade name of Device: None (to be produced for multiple private labels)
Common Name: Drain/Slit Sponge (Non-Sterile and Sterile)
Classification Name: Synthetic Sponge (Non-Sterile and Sterile) (21 CFR 878.4060)

The products to be manufactured by Igenics, Inc. are non-sterile and sterile versions of a nonwoven synthetic drain/slit sponge that is substantially equivalent to the general use sponges currently produced by Igenics, Inc. for multiple private labels. For other substantially equivalent devices, see general use sponges marketed by Johnson & Johnson Medical, Inc. known as Nu Gauze and general use sponges marketed by Kendall Co. known as Versalon. The drain/slit sponges do not have a different intended use or different technological characteristics than the general use sponges, except that the drain/slit sponges have a slit cut in them to accommodate a tube or needle. The drain/slit sponges are made of rayon and polyester fibers and will be sterilized by radiation or ethylene oxide methods. The finished products have a pattern similar to traditional cotton gauze, but they are softer and more absorbent. The Igenics products also have minimal linting and wound adhesion compared to traditional cotton gauze. It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.

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