DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560

K061864 · Dukal Corp. · FXX · Sep 15, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061864
• Device Name: DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
• Applicant: Dukal Corp.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 15, 2006
• 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 protective barriers for nose and mouth. Construction includes inner/outer layers of spun-bond polypropylene or medical grade tissue and a middle layer of melt-blown polypropylene filter media. Features include malleable aluminum nose wire and soft latex-free elastic ear loops or ties; specific models include anti-fog treated plastic splash visors. Used in clinical settings by healthcare workers and patients to mitigate exposure to microorganisms, body fluids, and aerosols. Device functions as a physical barrier; performance verified via fluid resistance, particulate filtration, and bacterial filtration testing. Output is a protective barrier; clinical benefit is reduced risk of cross-contamination during procedures.

Clinical Evidence

Bench testing only. Performance compared to predicate (K051291) using ASTM standards: Fluid Resistance (ASTM F1862-05, 30/32 passed vs 19/32), PFE (ASTM F2299, 98.3% vs 98.7%), BFE (ASTM F2101-01/F2100-04, 99.9% vs 99.8%), and Differential Pressure (2.28 mmH2O/cm2 vs 2.28 mmH2O/cm2). Flammability testing confirmed Class 1 rating.

Technological Characteristics

3-ply mask; inner/outer layers: spun-bond polypropylene or medical grade tissue; middle layer: melt-blown polypropylene filter; nose piece: malleable aluminum wire; ear loops/ties: latex-free elastic; optional anti-fog plastic shield (ATFF-High Impact 0.10mm). Performance standards: ASTM F2100-04, ASTM F1862-05, ASTM F2299, ASTM F2101-01.

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

• A.R. Medicom (K051291)
• ValuMax International (K040333)

Submission Summary (Full Text)

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

K061864

## 510(k) Summary

# SEP 1 8 2006

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

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

### Predicate Devices

- 510(k) Number 1. A.R. Medicom K051291
2. ValuMax International (K040333

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

K061864

.

| 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) |

:

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

ッ

: : :

| Item | Test Method | Dukal | Medicom K051291 |
|---------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------|
| Inner Layer | Raw material<br>Specifications | 100% Spun-bond<br>polypropylene<br>or medical grade<br>tissue (25 gsm) | Same |
| Outer Layer | Raw material<br>Specifications | 100% Spun-bond<br>polypropylene or<br>medical grade<br>tissue (16gsm) | 100% Spun-bond<br>polypropylene or medical<br>grade tissue (14gsm) |
| Middle Layer | Raw material<br>Specifications | 100% melt blown<br>polypropylene<br>filter media<br>(25 gsm) | Same |
| Ear Loop | Raw material<br>Specifications | Soft latex free<br>elastic loops and<br>ties<br>(40 gsm) | Latex Free Elastic Loops<br>and ties<br>38 gsm |
| Nose Piece | Raw material<br>Specifications | Malleable<br>aluminum wire | same |
| Plastic Shield | Raw material<br>Specifications | ATFF-High<br>Impact 0.10mm | same |
| Fluid<br>Resistance<br>Performance<br>(mmHg) | ASTM F1862-05<br>Pressure at 80mm<br>Hg | 30 out of 32<br>passed | 19 out of 32 passed |
| Particulate<br>Filtration<br>Efficiency<br>Performance<br>(%) | ASTM2299 | 98.3% | 98.7% |
| Bacterial<br>Filtration<br>Efficiency<br>Performance<br>(%) | ASTM F2101-01<br>ASTM F2100-04 | 99.9% | 99.8% |
| Item | Test | Dukal | Medicom K051291 |
| Differential Pressure<br>(Delta-P)<br>(mmH20/cm2) | ASTM F2101-01<br>MIL-M-36945C<br>4.4.1.1.1 Method 1 | 2.28 (ave)<br>mmH2O/cm² | 2.28 (ave)<br>mmH2O/cm² |
| Flammability class<br>1 | ASTM F2101-01<br>MIL-M-36945C<br>4.4.1.1.1 Method 1 | No Flame Spread<br>Class 1 | No Flame Spread<br>Class 1 |
| Mask Styles | | Tie, Ear Loop and<br>mask with fluid<br>shield | Tie, Ear Loop and<br>mask with fluid<br>shield |
| Color | | Blue | Blue |
| Layers | | 3 | 3 |
| | | | |

# Performance Characteristics

.

{3}------------------------------------------------

K061864

.. . . .

: 上

# Performace Characterics, con't

{4}------------------------------------------------

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 8 2006

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

Re: K061864

Trade/Device Name: Dukal Surgical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 18, 2006 Received: September 13, 2006

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 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.

{5}------------------------------------------------

#### 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 (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 yours,

Clara

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

{6}------------------------------------------------

#### Indications for Use

्

510(k) Number (if <nown): K061864

Device Name: Dukal Surgical Face Masks

Indications for Use:

The Dukal medical / surgical masks are indicated as a protective nose and mouth I his Dukar modiets 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.

meroorganison, boxs catalog numbers (these numbers can change with updated revisions to the catalog):

| Catalog | Face Mask Description | Model Type |
|---------|-----------------------|----------------------------|
| Number | | |
| 1530 | Face Mask | Ear Loops |
| 1540 | Face Mask | Ties |
| 1560 | Face Mask | Fluid Shield with Ear Loop |
| 1570 | Face Mask | Fluid Shield with Ties |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy, MD 3/18/04

on of Anesthesiology, General Hospital. uon Control, Dental Devices

Number: K 011 844