SURGICAL FACE MASK

K043199 · Hong YA Non-Woven Products Co., Ltd. · FXX · Feb 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043199
• Device Name: SURGICAL FACE MASK
• Applicant: Hong YA Non-Woven Products Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical Face Mask is device that is 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 fluids and particulate material.

Device Story

Flat pleated 3-ply surgical face mask; inner and outer layers of spunbonded polypropylene; middle layer of meltblown polypropylene filter; malleable aluminum nosepiece; elastic ear loops or strips. Used by operating room personnel during surgical procedures. Provides barrier protection against microorganisms, body fluids, and particulates. Device is disposable.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including fluid resistance (ASTM F1862-00a), bacterial filtration efficiency (ASTM F2101-01), particulate filtration efficiency (ASTM F1215-89), differential pressure (MIL M 36954C), flammability (16 CFR 1610), and biocompatibility (ISO 10993).

Technological Characteristics

3-ply flat pleated mask; materials: spunbonded polypropylene (outer/inner), meltblown polypropylene (filter); malleable aluminum wire nosepiece; elastic loops/strips. Standards: ASTM F1862-00a (fluid resistance), ASTM F2101-01 (BFE), ASTM F1215-89 (particulate filtration), MIL M 36954C (Delta-P), 16 CFR 1610 (flammability), ISO 10993 (biocompatibility).

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patients and staff from transfer of microorganisms, body fluids, and particulate material.

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

• Tucker & Associates Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green (K022256)

Submission Summary (Full Text)

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# 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: KO43/99

K043/99

# 1.__Submitter's Identification:

Mr. Li Hua Zhu/General Manager Hong Ya Non-Woven Products Co., Ltd. Donggao Industry Zone Zanhuang, Hebei Province P.R. China

Official Correspondent and US Agent: James Chu Gloveco Inc. 590 W. Central Avenue, #D Brea, CA 92821 Tel: [phone] Fax: [phone] Email: [e-mail]

Date Summary Prepared: September 09, 2004

## 2. Classification Name:

Classified by FDA's General and Plastic Surgery Device panel as Class II, 21 CFR 878.4040, Surgical Apparel, 80FXX Mask, Surgical

## 3. Regulatory Reference:

21 CFR 878.4040

## 4. Name of the Device:

Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue)

### 5. Predicate Device Information:

Tucker & Associates

Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green (K022256)

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#### 6. Device Description:

Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is flat pleated 3-ply masks with an inner and outer layer (spunbonded polypropylene) that sandwich a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is malleable aluminum wire. All the material used in the construction of the Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) are being used in currently marked devices.

### 7. Labels/Labeling:

This device will be marked to medical device suppliers, Dentist and Doctor Offices, Clinics, Emergency Response Professionals, Hospitals and other healthcare professionals for the Intended Use purpose below.

### 8. Intended Use:

Surgical Face Mask is device that is 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 fluids and particulate material.

#### 9. Comparison to Predicate Devices:

Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is substantially equivalent in safety and effectiveness to the Tucker & Associates Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green.

| Test | K022256 | Hong Ya Surgical Face<br>Mask (Blue) |
|---------------------------------------------------------|-----------------------|--------------------------------------|
| Fluid Resistance | No visual Penetration | Fluid Resistant |
| Particulate Filtration<br>Efficiency Performance<br>(%) | 2.0 microns | Average 98.8% at 0.1 micron |
| BFE (%) | 97.9% | 99.4% |
| Delta-P | 1.8 | 1.6 |
| Flammability Class | 2 | 1 |

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### 10. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:

- Fluid Resistance (ASTM F1862-00a): Synthetic Blood Penetration Resistance l . 'l`est
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM II. F2101-01) and Particulate Filtration Efficiency (Latex Particle Challenge) (ASTM F121589)
- Differential Pressure (Delta P) Test (MIL M 36954C) III.
- IV. Flammability Test (16 CFR 1610)
- Biocompatibility per ISO 10933 V.

It was our conclusion that performance testing met all relevant requirements of the aforementioned test standard.

### 11. Discussion of Clinical Tests Performed:

Not Applicable

#### 12. Conclusions:

Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue) has the same intended use and technological characteristics as the predicated devices (K022256). Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness. Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue) is substantially equivalent to the predicate device.

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of one.

# FEB 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hong Ya Non-Woven Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 W. Central Avenue, #D Brea, California 92821

Re: K043199

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: February 1, 2005 Received: February 2, 2005

Dear Mr. Chu:

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. Chu

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 moun that I Dr mas made 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 and ifoung (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form aroduct radiation control provisions (Sections 531-542 of the Act); appress 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 m 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), 11 you donto 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,

Syrtle Machie, M.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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# Attachment A

# INDICATIONS FOR USE

510(k) NUMBER (IF KNOWN) : APPLICANT: DEVICE NAME:

043199 Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue)

INDICATIONS FOR USE:

Surgical Face Mask is device that is 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 fluids and particulate material.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

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Division of Anesthesiology, General Hospital,
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2/16/05

Infection Control Dental Devices 510(k) Number