MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK

K981073 · Medcom Laundry Service, Inc. · FYA · May 15, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981073
• Device Name: MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
• Applicant: Medcom Laundry Service, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: May 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room peronnel from the transfer of microorganisms, body fluids, and particulate material. Return to Medcom Laundry Services after use for reprocessing / recycling. To be used as a protective patient covering, such as to isolate the site of suraical incision from microbial and other contamination. Return to Medcom Laundry Services after use for reprocessing / recycling. To be used as an accessory to other surgical drapes; wiping, blotting, hand drying, etc. Return to Medcom Laundry Services after use for reprocessing / recycling.

Device Story

Medcom Gown Pack, Drape Pack, and Towel Pack are reusable textile surgical apparel and accessories. Gown packs protect OR personnel and patients from cross-contamination of microorganisms, fluids, and particulates. Drape packs isolate surgical incision sites from contamination. Towel packs serve as accessories for wiping, blotting, or hand drying. Devices are used in surgical environments by OR staff. After use, items are returned to Medcom Laundry Services for professional reprocessing and recycling to maintain sterility and barrier performance for subsequent uses.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable textile-based surgical apparel and accessories (gowns, drapes, towels). Designed for reprocessing and recycling. No electronic, software, or energy-based components.

Indications for Use

Indicated for operating room personnel and surgical patients during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate material. Includes surgical gowns, drapes, and towels for use in clinical surgical settings.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 1998

Mr. Gary VanDriel President Medcom Laundry Services, Incorporated 517 North Link Lane, Unit D Fort Collins, Colorado 80524

Re : K981073 Trade Name: Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable Regulatory Class: II FYA/KKX Product Code: Dated: March 18, 1998 March 24, 1998 Received:

Dear Mr. VanDriel:

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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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

{1}------------------------------------------------

Page 2 - Mr. VanDriel

through 542 of the Act for devices under the Electronic enrough Badiation Control provisions, or other Federal laws or requlations.

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"(21CFR 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/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 510 (K) PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

K981073 510 (K) NUMBER

med Com GOWN PACK / DRAPE PACK (Reusable) DEVICE NAME:

INDICATIONS FOR USE:

To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room peronnel from the transfer of microorganisms, body fluids, and particulate material.

Return to Medcom Laundry Services after use for reprocessing / recycling.

DEVICE NAME: DRAPE PACK

INDICATIONS FOR USE:

To be used as a protective patient covering, such as to isolate the site of suraical incision from microbial and other contamination.

Return to Medcom Laundry Services after use for reprocessing / recycling.

DEVICE NAME: TOWEL PACK

INDICATIONS FOR USE:

To be used as an accessory to other surgical drapes; wiping, blotting, hand drying, etc.

Return to Medcom Laundry Services after use for reprocessing / recycling.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lin

OR

- PAGE 7 -

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescriptive Use (Per 21 CFR 801.109) Over-The-Counter Use

Image /page/2/Picture/19 description: The image contains a handwritten letter 'X' above a thick black line. The 'X' is formed by two intersecting diagonal strokes, with the left stroke appearing slightly lighter than the right. The black line is straight and positioned horizontally, serving as a base or underline for the letter.