SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP

K063043 · Modern Healthcare Corp. · FXX · Mar 21, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063043
• Device Name: SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
• Applicant: Modern Healthcare Corp.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.

Device Story

Disposable surgical face mask; 3-ply construction; inner and outer layers of spunbonded polypropylene; middle layer of melt-blown polypropylene filter material; malleable aluminum nosepiece; available in tie-on or ear-loop configurations. Used by operating room personnel, healthcare professionals, and emergency responders to provide a physical barrier against microorganisms, body fluids, and particulates during surgical procedures. Device is non-sterile.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

3-ply flat pleated mask; materials: spunbonded polypropylene (inner/outer layers), melt-blown polypropylene (filter layer); malleable aluminum nosepiece; elastic loops or tie-on strips; non-sterile; disposable.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect patients and personnel from transfer of microorganisms, body fluids, and particulate material. Non-sterile, disposable device.

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 Face Mask (K060776)

Submission Summary (Full Text)

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**MODERN HEALTHCARE CORP.**
公司:彰化縣田中鎮中州路二段751號
751 CHUNG CHOU RD., SEC. 2. TIEN CHUNG.
CHANG HWA. TAIWAN R.O.C
TEL: [phone]~8 ; FAX : [phone]

MAR 2 1 2007

### 510(k) SUMMARY "

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92

# The assigned 510(k) number is : K 063043

### Submitter's Name: MODERN HEALTHCARE CORP.

No.751, Chung Chou Rd., Sec. 2, Tien Chun County, Chang-Hwa, 52045, Taiwan, R.O.C.

#### Date summary prepared:

September 29, 2006

### Device Name:

- Classification name: Mask, Surgical .
- FXX, Class II Classification number:
- 878.4040 Regulation Number:
- Surgical Face Mask, Type: Tie-on, Ear-loop . Proprietary name:
- Common name of device: Surgical Face Mask, Disposable .
- . Predicate Device: Surgical Face Mask, K060776
- . Official Correspondent: Dr. Jen, Ke-Min

E-mail: [e-mail] (Tel) 886-3-5208829; (Fax) 886-3-5209783

Address: No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC

#### Description of the device:

Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum All the materials used in the construction of the Modern Healthcare Corp. Surgical wire. Face Mask are being used in currently marked devices.

#### Labels/Labeling:

This device will be marked to medical device suppliers, Dentist and Doctor Officers, clinics, Emergency Response Professionals, Hospitals and other healthcare professional for the Intended Use purpose below:

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Image /page/1/Picture/0 description: The image shows the word "Modern" in a stylized font. The "M" is designed to look like a heart shape. There is a registered trademark symbol to the right of the word.

### 一粒候,工 MODERN HEALT 公司:彰化縣田中鎮中 751 CHUNG CHOURD TEL : [phone] : FAX : 886

## Discussion of Clinical Tests Performed:

Not Applicable

#### Conclusions:

Modern Healthcare Corp., Surgical Face Mask, type: Tie-on and Ear-loop, has the same intended use and technological characteristics as the predicated devices (K060776). Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new question of safety or effectiveness. Modern Healthcare Corp., Surgical Face Mask, type: Tie-on and Ear-loop, is substantially equivalent to the predicated device.

Thus the new device is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 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 or other bird-like figure with three wing-like shapes.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Modern Healthcare Corporation C/O Dr. Ke-Min Jen Official Correspondent ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City 30067 TAIWAN, ROC

MAR 2 1 2007

Re: K063043

Trade/Device Name: Surgical Face Mask, Type: Tie-on, Ear Loop Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: January 23, 2007 Received: January 29, 2007

Dear Dr. Jen:

We have reviewed vour 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 - Dr. Jen

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-Lien, 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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Image /page/4/Picture/0 description: The image shows the word "Modern" in a stylized font. The "M" is designed to look like a heart shape. There is a circled R symbol next to the word, indicating a registered trademark.

新橡膠工業股份有限公司
**MODERN HEALTHCARE CORP.**
公司:彰化縣田中鎮中川路二段751號
751 CHUNG CHOU RD.. SEC. 2. TIEN CHUNG
CHANG HWA TAIWAN R.O.C
TEL: [phone] FAX: [phone]

# Indications for Use

510 (K) Number ( If Known ):

Device Name: Surgical Face Mask, Type: Tie-on, Ear-loop

Indications for Use:

The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.

! *CAUTION:*

This Surgical Face Mask is non-sterilized and disposable for use.

Prescription Use

AND/OR

Over-The-Counter Use √

(Part 21 CFR 801 Subpart D)

(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)

Shake It Mugler D

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