MEDLINE IODOFORM PACKING STRIPS

K052720 · Medline Industries, Inc. · FRO · Oct 20, 2005 · SU

Device Facts

• Record ID: K052720
• Device Name: MEDLINE IODOFORM PACKING STRIPS
• Applicant: Medline Industries, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Medline Iodoform Packing strips are intended for use for general wound packing.

Device Story

Medline Iodoform Packing Strips are sterile, gauze-based packing materials used for general wound management. The device is intended for use in clinical or home settings to pack wounds, facilitating drainage and healing. It is applied by healthcare professionals or patients as directed. The strips function as a mechanical dressing to fill wound cavities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gauze-based packing strips impregnated with iodoform. Sterile, single-use, non-electronic, non-software device.

Indications for Use

Indicated for general wound packing in patients requiring wound care.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2005

Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060

Re: K052720

Trade/Device Name: Medline Iodoform Packing Strips Regulatory Class: Unclassified Product Code: FRO Dated: September 27, 2005 Received: September 29, 2005

Dear Ms. Simmons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 9 roxity people is substantially equivalent (for the indications ferenced above and have decembers and and and and the sunces marketed in interstate for use stated in the enclosate) (6 region) in the Medical Device Amendments, or to contineres print to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not require to the general controls provisions of the Act. The r va may, merefore, mainer of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device is elabilional controls. Existing major regulations affecting your device can may be sabject to seen as a steel Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease to acribed a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I edelar statutes and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Lara N. Simmons

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification: "The PDF intemsgassification 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), plcase If you desire specific acrite 10-10-10-10-115. Also, please note the regulation entitled, Comation of Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Rardare pouent
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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652720

Page of

510(k) Number (if known): ***_***

Device Name: Medline Iodoform Packing Strips Indications for Use:

Medline Iodoform Packing strips are intended for use for general wound packing.

052720

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use xx

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saubare PremeD for mxin
Division Sign-Off

Division of General, Restorative, and Neurological Devices

(Division Sign-On)
Division of General Restorative

(Optional Format 12-96)

510(k) Number K052730

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