DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE

K070407 · Dukal Corp. · FXX · Mar 26, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070407
• Device Name: DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
• Applicant: Dukal Corp.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

Device Story

Dukal Surgical Face Masks are 3-ply pleated masks designed to cover the nose and mouth. Construction includes inner/outer layers of medical-grade tissue or spun-bond polypropylene and a middle layer of melt-blown polypropylene filter. Features include malleable aluminum nose pieces and latex-free elastic ear loops or ties. Certain models include an anti-fog plastic splash visor. Used in clinical settings by healthcare workers and patients to provide a physical barrier against microorganisms, body fluids, and particulate aerosols. The device functions as a passive protective barrier; no active processing or electronic output is involved.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM 2100-04 standards.

Technological Characteristics

3-ply pleated design. Materials: medical-grade tissue, spun-bond polypropylene, melt-blown polypropylene filter, aluminum nose wire, latex-free elastic. Some models include anti-fog plastic splash shield. Performance conforms to ASTM 2100-04.

Indications for Use

Indicated for healthcare workers and patients as a protective nose and mouth covering during medical and surgical procedures to reduce risk of microorganism, body fluid, and particulate aerosol transfer.

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

• Dukal (K061864)
• A.R. Medicom (K051291)
• ValuMax Surgical Fog Free & 3 Ply Masks (K04033)

Submission Summary (Full Text)

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K070407

# 510(k) Summary 2-07-07

MAR 2 6 2007

Device Trade Name: Non Sterile Surgical Mask

Name and Address of Manufacturer: Dukal Corporation 5 Plant Ave Hauppauge, NY 11788

Establishment Registration: 2435946

- Contact Person: Patrick J. Lamb Vice President International Operations 5 Plant Ave. Hauppauge, NY 11788 Tel: [phone] Fax: [phone] e-mail: [e-mail]
#### Device Classification

Name: Mask, Surgical

Classification Panel: Class II, §878.4040

#### Classification Advisory

Committee: General and Plastic Surgery

Product Code: FXX

### Recognized Performance

Standard:

ASTM 2100-04 Refer to submission for applicable standards

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# K670407

| Predicate Devices<br>510(k) Number | 1. Dukal K061864<br>Product Codes 1530, 1540, 1560, 1570<br>2. A.R. Medicom K051291<br>Product Codes: 2000, 2030, 2025, 400506<br>3. ValuMax K04033, Blue, Yellow & White<br>Surgical Fog Free & 3 Ply Masks |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Dukal medical / surgical masks are indicated as a<br>protective nose and mouth covering for healthcare workers<br>and patients involved in medical and surgical procedures.<br>The masks are indicated in any procedure or situation<br>where there is a risk of microorganism, body fluid and<br>particulate aerosol transfer. |
| 510(k) Statement: | A 510(k) statement for this device, as required by 21 CFR 93, is<br>replaced with this 510(k) summary. |
| Truthful and Accurate<br>Statement: | A Truthful and accurate statement as required by 21 CFR<br>§807.87(j) may be found in the submission in Exhibit A |
| Labeling: | Samples of proposed labeling may be found in the submission in<br>Exhibit B |
| Device Description: | Dukal Surgical Masks are pleated 3 - ply masks. Inner and<br>outer layers are made of either medical grade tissue or<br>100% spun-bond polypropylene. Middle layer is made of<br>100% melt blown polypropylene filter. Ear loops<br>are made of soft latex free elastic loops. The nose piece for<br>all Dukal Masks is a malleable aluminum wire. Masks with splash<br>visors have an anti fog treated plastic shield attached to masks. All<br>of the material used in the construction of the Dukal face<br>masks are being used in currently marketed devices (see<br>predicate information) |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Patrick J. Lamb Vice President Dukal Corporation 5 Plant Avenue Hauppauge, New York 11788

MAR 2 6 2007

Re: K070407

Trade/Device Name: Dukal Surgical Face Mask; 1530 Yellow Surgical Face Mask Tie; 1531 Yellow Surgical Face Mask Ear Loop; 1540 White Surgical Face Mask Tie: 1541 White Surgical Face Mask Ear Loop; 1550; Anti Fog Yellow Surgical Face Mask Tie; 1551 Anti Fog Yellow Surgical Face Mask Ear Loop; 1552 Anti Fog White Surgical Face Mask Tie; 1553 Anti Fog White Surgical Face Mask Ear Loop; 1554 Anti Fog Blue Surgical Face Mask Tie: 1555 Anti Fog Blue Surgical Face Mask Ear Loop; 1560 Yellow Surgical Face Mask Tie with Shield: 1561 Yellow Surgical Face Mask Ear Loop with Shield; 1562 White Surgical Face Mask Tie with Shield; 1562 White Surgical Face Mask Ear Loop with Shield.

Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: March 1, 2007 Received: March 5, 2007

Dear Mr. Lamb:

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. Lamb

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.

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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# Indications for Use

510(k) Number (if known): K070407

Device Name: Dukal Surgical Face Mask (model number and complete device name attached)

Indications For Use: The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

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)

Shule H. Murphy, MD

Department of Anesthesiology, General Hospital,
Infection Control, Dental Devices

Number: A 022407

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## ATTACHEMENT-1 Indication for Use Statement

Device Name: 1530 Yellow Surgical Face Mask Tie 1531 Yellow Surgical Face Mask Ear Loop 1540 White Surgical Face Mask Tie 1541 White Surgical Face Mask Ear Loop 1550 Anti Fog Yellow Surgical Face Mask Tie 1551 Anti Fog Yellow Surgical Face Mask Ear Loop 1552 Anti Fog White Surgical Face Mask Tie 1553 Anti Fog White Surgical Face Mask Ear Loop 1554 Anti Fog Blue Surgical Face Mask Tie 1555 Anti Fog Blue Surgical Face Mask Ear Loop 1560 Yellow Surgical Face Mask Tie with Shield 1561 Yellow Surgical Face Mask Ear Loop with Shield 1562 White Surgical Face Mask Tie with Shield 1562 White Surgical Face Mask Ear Loop with Shield