WELMED, INC. SURGICAL GOWNS

K070431 · Welmed, Inc. · FYA · May 24, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070431
• Device Name: WELMED, INC. SURGICAL GOWNS
• Applicant: Welmed, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: May 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates. Gowns provided as 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.

Device Story

Disposable surgical gowns; protective apparel for operating room staff. Constructed from SMMS and SPP materials. Functions as physical barrier against body fluids and particulates. Provided in sterile and non-sterile configurations. Non-sterile versions intended for OEM EtO sterilization; sterile versions intended for direct clinical use. Used in OR environments to reduce cross-contamination risk between staff and patients.

Clinical Evidence

Bench testing only. Performance validated via AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), ASTM D5034 (tensile strength), ASTM D5734 (tear strength), ISO 9073-10 (lint generation), and 16 CFR 1610 (flammability). Biocompatibility confirmed per ISO 10993-1, 10993-5 (cytotoxicity), and 10993-10 (irritation/sensitization).

Technological Characteristics

Materials: SMMS and SPP nonwoven fabrics. Sterilization: EtO (ISO 11135). Biocompatibility: ISO 10993 compliant. Testing standards: AATCC 127, AATCC 42, ASTM D5034, ASTM D5734, ISO 9073-10, 16 CFR 1610.

Indications for Use

Indicated for use as a protective covering for operating room staff to prevent the transfer of body fluids and particulates.

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

• IMC Surgical Gowns (K052550)

Submission Summary (Full Text)

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K070431

### Section 5: 510(k) Summary

MAY 2 4 2007

#### 1.0 Submitted By:

Dave Fliss, President Welmed, Inc. 691 Lake Street Grayslake, IL 60030 Establishment Registration Number: 3005841027

Primary Contact: Glen Feye, President Accurate Consultants, Inc. 1340 West Pennsylvania Ave. San Diego, CA 92103 Telephone: [phone] Fax: [phone] [e-mail]

#### 2.0 Date Submitted:

February 8, 2007

#### 3.0 Device Name(s):

#### Proprietary Names 3.1

Welmed, Inc. Surgical Gowns

#### 3.2 Classification Name

21CFR 878.4040 (Surgical Gown) Product code - FYA (Gown, Surgical).

Welmed, Inc. Section 510(k) Notification Surgical Gowns Welmed+Gowns+510K+Draft+2-7-07

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#### 4.0 Predicate Devices:

| Candidate | Predicate | Manufacturer | Docket<br>Number |
|--------------------------|-----------------------|--------------------------------------------|------------------|
| Welmed Surgical<br>Gowns | IMC Surgical<br>Gowns | International Medsurg<br>Connections, Inc. | K052550 |

#### 5.0 Intended Use:

Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates.

Gowns provided as 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.

#### 6.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

| Product | Aspect/Characteristic | Comments |
|-----------------------------|----------------------------------|-------------------------------|
| Welmed<br>Surgical<br>Gowns | Basic Intended Use | Same as IMC<br>Surgical Gowns |
| | Materials Used – SMMS & SPP | |
| | Configurations/Design | |
| | Provided Sterile and Non-Sterile | |
| | Testing Methods | |

## Similarities to the Predicate

There are no significant differences between the Welmed products and their respective predicate products.

#### 7.0 Summary of Performance Data:

The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and testing methods.

Welmed, Inc. Section 510(k) Notification Surgical Gowns Welmed+Gowns+510K+Draft+2-7-07

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| Standard or Guidance Document | Data Generated | Relevant<br>Section of<br>Submission |
|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------|
| AATCC Test Method 127-1998<br>Water Resistance: Hydrostatic Pressure<br>Test | Hydrostatic<br>Pressure - Water<br>Resistance | 18 |
| AATCC Test Method 42-2000<br>Water Resistance: Impact Penetration Test | Impact Penetration<br>- Water Resistance | 18 |
| ASTM - D5034-95(2001) Standard Test<br>Method for Breaking Strength and<br>Elongation of Textile Fabrics (Grab Test) | Tensile Strength | 18 |
| ASTM - D5734-95(2001) Standard Test<br>Method for Tearing Strength of Nonwoven<br>Fabrics by Falling-Pendulum (Elmendorf)<br>Apparatus | Elmendorf Tear | 18 |
| ISO 9073-10:2003 - Textiles - Test<br>methods for nonwovens -- Part 10: Lint and<br>other particles generation in the dry state | Gelbo Flex - Lint | 18 |
| CPSC CS-191-53 Flammability Test<br>Method (16 CFR 1610) Standard for<br>Flammability of Clothing Textiles | Flammability | 18 |
| AAMI / ANSI / ISO 10993-1:2003(E).<br>Biological evaluation of medical devices --<br>Part 1: Evaluation and testing | Biocompatibility<br>Testing Evaluation | 15 |
| AAMI / ANSI / ISO 10993-5:1999, Biological<br>evaluation of medical devices -- Part 5:<br>Tests for In Vitro cytotoxicity | Cytotoxicity | 15 |
| AAMI / ANSI / ISO 10993-10:2002(E),<br>Biological evaluation of medical devices --<br>Part 10: Tests for irritation and sensitization | Skin Irritation, intra-<br>cutaneous<br>reactivity &<br>sensitization | 15 |

# Test Data Provided in this Submission

Welmed, Inc. Section 510(k) Notification Surgical Gowns Welmed+Gowns+510K+Draft+2-7-07

:

-

.

:

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

MAY 2 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Welmed. Incorporated C/O Mr. Glen Feye President Accurate Consultants, Incorporated 1340 West Pennsylvania Avenue San Diego, California 92103

Re: K070431

Trade/Device Name: Welmed, Incorporated Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 12, 2007 Received: May 8, 2007

Dear Mr. Feye:

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 your 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. Feye

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 (OS) 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 vours.

Chiu-Lin, Ph.D.

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

Enclosure

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### Section 4: Indications for Use Statements

# Indications for Use

510(k) Number (if known): 长O2043

Welmed Surgical Gowns Device Name:

Indications for Use:

Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates.

Gowns provided as 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 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A. Murphy, KD

Page 1 of

of Anesthesiology, General Hospital, Control, Dental Devices

) Number: K 670431

Welmed, Inc. Section 510(k) Notification Surgical Gowns Welmed+Gowns+510K+Draft+2-7-07

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February 8, 2007