MARKWELL GAUZE SPONGE

K982260 · Markwell Intl., Inc. · LWH · Aug 12, 1998 · General Hospital

Device Facts

• Record ID: K982260
• Device Name: MARKWELL GAUZE SPONGE
• Applicant: Markwell Intl., Inc.
• Product Code: LWH · General Hospital
• Decision Date: Aug 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2740
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed. Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.

Device Story

Markwell Gauze Sponge is a nonsterile, bulk-packaged gauze pad for external wound dressing. Intended for application to wound sites; requires replacement when wet or as needed. May be repacked and sterilized by domestic manufacturers for subsequent use. Operates as a passive mechanical barrier for wound management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nonsterile gauze sponge supplied in bulk (100/200 count). Passive mechanical dressing.

Indications for Use

Indicated for external use as a gauze sponge for wound dressing. Suitable for over-the-counter use.

Regulatory Classification

Identification

A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 1998

Mr. Sean Wanq ·Vice President Markwell International, Inc. 2550 West Main Street, Suite 212 Alhambra, California 91801

Re: K982260 Trade Name: Markwell Gauze Sponge Requlatory Class: Unclassified Product Code: EFO Dated: June 22, 1998 Received: June 26, 1998

Dear Mr. Wang:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.

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## Page 2 - Mr. Sean Wang

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.qov/cdrh/dsmamain.html".

Sincerely yours,

Russell U. Sayer

& 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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510 (k) NUMBER (IF KNOWN) : K982260 DEVICE NAME: Markwell Gauze Sponge INDICATIONS FOR USE:

Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed.

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Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.

Vessell, /. Eugene fr. IZO

(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 1-2-96)

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