GILTECH PLUS TRANSPARENT DRESSING

K992005 · Giltech Plus, Inc. · MGP · Sep 3, 1999 · SU

Device Facts

• Record ID: K992005
• Device Name: GILTECH PLUS TRANSPARENT DRESSING
• Applicant: Giltech Plus, Inc.
• Product Code: MGP · SU
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as: (a) Stage I and II pressure sores (decubitus ulcers) (b) Skin tears or lacerations (c) Superficial burns and abrasions (d) Surgical wounds

Device Story

Giltech Plus Transparent Dressing is a wound care product designed for management of moderately draining wounds. It functions as a protective barrier for various wound types, including pressure sores, skin tears, lacerations, burns, and surgical incisions. Used in clinical or home settings, it is applied by healthcare providers or patients to facilitate wound healing and protect the site from external contaminants. The dressing provides a moist environment conducive to healing while managing exudate.

Indications for Use

Indicated for management of moderately draining wounds, including Stage I and II pressure sores (decubitus ulcers), skin tears, lacerations, superficial burns, abrasions, and surgical wounds.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Mr. William J. Giliam President Giltech Plus Company, Inc. P.O. Box 728 Milford, Pennsylvania 18337

3 1999

Re: K992005 Trade Name: Transparent Dressing Regulatory Class: Unclassified Product Code: MGP Dated: June 10, 1999 Received: June 15, 1999

Dear Mr. Gilliam:

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 (QS) 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. William J. Giliam

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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K992005

## "INDICATIONS FOR USE"

Page _ 1 of of 1

510(k) Number (if known): K992005

Device Name: _Giltech Plus Transparent Dressing

Indications For Use:

The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:

(a) Stage I and II pressure sores (decubitus ulcers)

(b) Skin tears or lacerations

(c) Superficial burns and abrasions

(d) Surgical wounds

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asteves

(Division Sign-Off)
Division of General Restorative Devices K992005
510(k) Number.

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)