DYNAREX NON-WOVEN SPONGE

K991695 · Dynarex Corp. · KMF · Jul 15, 1999 · General Hospital

Device Facts

• Record ID: K991695
• Device Name: DYNAREX NON-WOVEN SPONGE
• Applicant: Dynarex Corp.
• Product Code: KMF · General Hospital
• Decision Date: Jul 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Non-Woven sponge for wound dressing prepping and scrubbing.

Device Story

Non-woven sponge used for wound dressing, prepping, and scrubbing. Device functions as a physical barrier or absorbent material for clinical wound care. Used in clinical settings by healthcare professionals or for patient care. Provides mechanical utility for cleaning and dressing wounds.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-woven material; sponge form factor; sterile.

Indications for Use

Indicated for use as a wound dressing, prepping, and scrubbing sponge for general patient populations.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Mr. John G. Moulden Senior Vice President Dynarex Corporation One International Boulevard Brewster, New York 10509

Re: K991695 Trade Name: Non-Woven Sponge Regulatory Class: Unclassified Product Code: KMF Dated: May13, 1999 Received: May 18, 1999

Dear Mr. Moulden:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. John G. Moulden

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991695 page 1 of 1

K991695 510(k) NUMBER (IF KNOWN):

Dynarex NOn-Woven Sponge, Sterile DEVICE NAME:

INDICATIONS FOR USE:

Non-Woven sponge for wound dressing prepping and scrubbing.

FDA/CDRH/ODE/DMC

Jun 23 3 48 PM '93

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR
Over-The-Counter-Use
(Optional Format 1-2-
(Division Sign-Off)

Division of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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