IMC SURGICAL GOWNS

K052550 · Intl. Medsurg Connection, Inc. · FYA · Nov 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052550
• Device Name: IMC SURGICAL GOWNS
• Applicant: Intl. Medsurg Connection, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

International Medsurg Connection's Surgical Gown is intended to be used as Patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

Device Story

IMC Surgical Gowns are protective garments for operating room personnel; used to isolate incision sites and prevent cross-contamination of microorganisms, body fluids, and particulates. Available in multiple configurations including non-reinforced, fabric-reinforced, and poly-reinforced versions in various sizes. Gowns are supplied either sterile or non-sterile; non-sterile units intended for OEM EtO sterilization per ISO 11135. Device functions as a physical barrier during surgical procedures.

Clinical Evidence

Bench testing only. Materials evaluated for cytotoxicity (ISO 10993-5), skin irritation/sensitivity (ISO 10993-10), systemic toxicity (ISO 10993-11), flammability (16 CFR 1610), hydrostatic pressure (AATCC 127), impact penetration (AATCC 42), lint generation (IST 160.1), and tensile strength (ASTM D5034).

Technological Characteristics

Surgical gowns available in non-reinforced, fabric-reinforced, and poly-reinforced configurations. Materials tested per ISO 10993 (biocompatibility), 16 CFR 1610 (flammability), AATCC 127/42 (barrier performance), and ASTM D5034 (tensile strength). Sterilization via EtO per ISO 11135.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect the patient and personnel from transfer of microorganisms, body fluids, and particulate matter.

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.

Predicate Devices

• Surgical Gowns (K030364)

Submission Summary (Full Text)

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### NOV 1 7 2005

#### SUMMARY OF THE SAFETY AND EFFECTIVENESS 10.0

International Medsurg Connection Surgical Gown

| Manufacturer: | International Medsurg Connection, Inc.<br>935 N Plum Grove Road, Suite F<br>Schaumburg, Illinois 60173-4770 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Manny Gupta<br>Vice President / General Manager<br>International Medsurg Connection, Inc.<br>935 N Plum Grove Road, Suite F<br>Schaumburg, Illinois 60173-4770 |
| Telephone: | 847-619-9929 |
| Date Summary Prepared | August 5, 2005 |
| Product Trade Name: | IMC Surgical Gowns - Multiple |
| Common Name: | Surgical Gown. |
| Classification: | Class II |
| Predicate: | Surgical Gowns, Reference K030364<br>owned by DeRoyal Industries. |
| Description: | Surgical Gowns including various sizes<br>and material. |

### Intended Use:

International Medsurg Connection's Surgical Gown is intended to be used as Patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

### Substantial Eguivalence:

The International Medsurg Connection Surgical Gowns are substantially equivalent to the Surgical Gown sold by DeRoyal Industries, Reference K030364.

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## IMC GOWN LIST

| Catalog Number | Description |
|----------------|---------------------------------------|
| Surgical Gowns | |
| 260-2001 | Non reinforced Large |
| 260-2002 | Non reinforced X-Large |
| 260-2003 | Non reinforced XX-Large |
| 260-2101 | Fabric reinforced Large |
| 260-2102 | Fabric reinforced X-Large |
| 260-2103 | Fabric reinforced XX-Large |
| 260-2201 | Poly-reinforced Large |
| 260-2202 | Poly-reinforced X-Large |
| 260-2203 | Poly-reinforced XX-Large |
| 260-2301 | Breathable Large, Extra Long |
| 260-2302 | Breathable X-Large, Extra Long |
| 260-2303 | Breathable XX-Large, Extra Long |
| 260-9211 | Fabric reinforced Large, Extra Long |
| 260-9212 | Fabric reinforced X-Large, Extra Long |
| 260-9115 | Non reinforced Large, Extra Long |
| 260-9116 | Non reinforced X-Large, Extra Long |

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K052556

They provide the following characteristics: Intended use is the same Similar configurations Similar materials

### Summary of testing:

Comments of the country and secures with and

All material used in the fabrication of the IMC Surgical Gowns were evaluated for:

| Test | Standard |
|----------------------|---------------------|
| Cytotoxicity | ISO 10993 - Part 5 |
| Skin Irritation | ISO 10993 - Part 10 |
| Skin Sensitivity | ISO 10993 - Part 11 |
| Systemic Toxicity | ISO 10993 - Part 11 |
| Flammability | 16 CFR Part 1610 |
| Hydrostatic Pressure | AATCC 127 |
| Impact Penetration | AATCC 42 |
| Lint | IST 160.1 |
| Tensile Strength | ASTM D5034 |

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The bird is facing to the right.

Public Health Service

NOV 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Manny Gupta Vice President/General Manager International Medsurg Connection, Incorporated 935 North Plum Glove Road, Suite F Schaumburg, Illinois 60173-4770

Re: K052550

:

Trade/Device Name: IMC Surgical Gowns-Various Sizes and Configurations, Per Attached List Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 3, 2005 Received: November 7, 2005

Dear Mr. Gupta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Gupta

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 comply with all the Act's requirements, including, but not 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,

Sujite H. Michie Dnd

Čhiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use

# 510K Number : _ K O52550

Device name: IMC Surgical Gowns – Various sizes and configurations per attached list

### Indication For Use:

This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.

This submission includes Surgical Gowns that will be sold both sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Prescription Use X (Partb21 CFR 801 Subpart D) AND/OR

Over-The counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shinda H. Murphy, KD 11/17/05
(Division Sign-off)

Division of anesthesiology, General Hospital. Infection Control Dental Devices