N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028

K072067 · Shuenn Bao Shing Corporation · MSH · Jan 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072067
• Device Name: N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
• Applicant: Shuenn Bao Shing Corporation
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Jan 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Device Story

N95 surgical respirator (models AP0018, AP0028) designed for single-use protection against microorganisms, blood, body fluids, and airborne particulates. Device consists of 3-ply flat pleated mask (polypropylene meltblown center layer, nonwoven outer layers) or molded cup design; features braided synthetic elastic headbands and flexible wire nosepiece for fit. Used by operating room personnel and healthcare workers in clinical settings. Provides physical barrier to reduce transfer of contaminants. No fiberglass media used. Non-sterile.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including NIOSH exhalation/inhalation resistance, NIOSH NaCl filtration efficiency, flammability (16 CFR 1610, class I), and biocompatibility (ISO 10993).

Technological Characteristics

3-ply mask; polypropylene meltblown filter media; nonwoven outer/inner layers; braided synthetic elastic headbands; aluminum/wire nosepiece. Dimensions: 24.5x8.5x8.7 cm (AP0028). Non-sterile. Complies with ASTM2100-04 Low Barrier. NIOSH N95 certified.

Indications for Use

Indicated for single use by operating room personnel and healthcare workers to protect patients and staff from microorganisms, blood, body fluids, and airborne 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

• Pleats Plus N95 Respirator 1050 and 1050S (K041855)

Reference Devices

• SHUENN BAO SHING Surgical Mask (K990719)
• 3M Surgical Mask (K955382)
• 3M Model 1860 Health Care Respirator (K955382)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "AERO PRO". The logo features a stylized design resembling the letters "A" and "P" intertwined, with curved lines suggesting movement or aerodynamics. Below the symbol, the words "AERO PRO" are printed in a simple, sans-serif font, completing the branding for the company.

SHUENN BAO SHING CO., LTD. No. 90.HSIN KUNG 6 RD., FIEN CHUNG CHEN.CHANG HW A HISTEN. Taiwan, ROC Tel [phone] Fax [phone] E-mail:shuennba(@ms17.hinet.net http://www.aeropro.com w

# 510(k) SUMMARY "

JAN -8 2008

July 20, 2007

The assigned 510(k) number is : K 072067

Submitter's Name: SHUENN BAO SHING CORPORATION

No. 90. Hsin Kung 6 Rd., Tien Chung Chen, Chang Hua Hsien, 52046, Taiwan, R.O.C.

#### Date summary prepared:

#### Device Name:

- Respirator, Surgical ● Classification name:
- Classification number: MSH, Class II
- Regulation Number: 878.4040
- N95 Surgical Respirator, Type: AP0018, AP0028 ● Proprietary name:
- . Common name of device: Surgical Respirator
- Predicate Device: Surgical N95 Respirator, K041855
- . 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:

SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to the bridge of the wearer's nose. No fiberglass media is used in this product.

#### 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 a logo with the words "AERO PRO" in a bold, sans-serif font at the bottom. Above the text is a stylized graphic that resembles the letters "A" and "P" combined, with three curved lines extending upwards from each letter. The logo has a textured, slightly distressed appearance, giving it a vintage or industrial feel.

SHIENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD., ITEN CHUNG CHEN.CHANG HWA HSIEN. Taiwan, ROC Tel. [phone] Fax [phone] E-mail:[e-mail] http://www.aeropro.com w

## Intended Use:

The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

# Comparison to Predicate Devices:

SHUENN BAO SHING Corporation N95 Surgical Respirator AP0018 and AP0028 are substantially equivalent is safety and effectiveness to the predicate device: AEARO Company, K041855, Pleats Plus N95 Respirator 1050 and 1050S for Reference: FXX, 878.4040, Class II 1) SHUENN BAO SHING Surgical Mask, K990719 2)3M Surgical Mask, K955382

| Manufacturer | Shuenn Bao Shing Corporation<br>(New Device) | Aearo Company<br>(Predicate Device) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | AP0028 N95 Surgical Respirator | Pleats Plus N95 Respirator 1050<br>and 1050S |
| 510(k) Number | TBA | K041855 |
| Product Code | MSH, 878.4040 | SAME |
| Device Description | 1. N95 Class particulate respirator<br>2. Multi-Layer Filtering media<br>(White spunbond polypropylene,<br>Meltblown polypropylene)<br>3. Plastic Nose Wire- with Aluminum<br>4. Transparent PU headband<br>5. Dimensions:<br>24.5x8.5x8.7 cm<br>6. Flat pleated mask<br>7. Dual elastic head strap | 1. N95 Class particulate respirator<br>2. Multi-Layer Filtering media<br>(White spunbond polypropylene,<br>Meltblown polypropylene)<br>3. Tie wire nose piece<br>4. White Elastic headband<br>5. Dimensions:<br>1) Small (13.5" circumference)<br>2) Large (15.5" circumference)<br>6. Flat pleated mask<br>7. Dual elastic head strap |
| NIOSH Approval Number | TC-84A-4175 | TC-84A-2630 |
| Regulatory Class | Class II (ASTM2100-04 Low Barrier) | SAME |

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Image /page/2/Picture/0 description: The image shows a logo with the words "AERO PRO" in a stylized font. Above the text, there is a symbol that resembles the letters "A" and "P" combined, with curved lines suggesting movement or aerodynamics. The overall design appears to be for a company or product related to aviation or aerodynamics.

SHI ENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD., FIEN CHUNG CHEN.CHANG INVA HSIEN. Taiwan, ROC Tel [phone] Fax [phone] E-mail shuennba(dims) 7.hinet.net http://www.aeropro.com/w

| Manufacturer | Shuenn Bao Shing Corporation<br>(New Device) | 3M<br>(Predicate Device)--for reference |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | AP0018 N95 Surgical Respirator | Model 1860 Health Care Respirator |
| 510(k) Number | TBA | K955382 |
| Product Code | MSH, 878.4040 | FXX, 878.4040 |
| Device Description | 1. N95 Class particulate respirator<br>2. Multi-Layer Filtering media<br>3. Wire nose clip<br>4. Foam nose piece inside mask<br>5. Yellow elastic headband<br>6. White colored<br>7. Molded cup mask<br>8. Protruded wings prevent punching staple holes on the mask. | 1. N95 Class particulate respirator<br>2. Multi-Layer Filtering media<br>3. Fluid resistant barrier<br>4. Wire nose clip<br>5. Foam nose piece inside mask<br>6. White elastic headband<br>7. Blue colored<br>8. Molded cup mask |
| NIOSH Approval Number | TC-84A-4049 | TC-84A-006 |
| Regulatory Class | Class II (ASTM2100-04 Low Barrier) | SAME |

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

| I. | NIOSH, Exhalation Resistance Test | 84.188 |
|----|-----------------------------------|--------|
|----|-----------------------------------|--------|

- II. NIOSH, Inhalation Resistance Test 84.180
- NIOSH, Sodium Chloride (NaCl)--N95 III. 84.181
- Flammability, complied with16 CFR 1610, class I IV.
- Biocompatibility per ISO 10993 V.

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

#### Discussion of Clinical Tests Performed:

Not Applicable

#### Conclusions:

SHUENN BAO SHING Corp., Surgical Respirator, type: AP0018 and AP0028, has the same intended use and technological characteristics as the predicated devices (K041855). Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new question of safety or effectiveness. SHUENN BAO SHING Surgical Respirator type AP0018 and AP0028 are substantially equivalent to the predicated device.

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

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Image /page/3/Picture/0 description: The image shows a logo for "AERO PRO". The logo features a stylized design above the text, resembling curved lines that form the letters "A" and "P". The text "AERO PRO" is written in a simple, sans-serif font below the design. The entire logo has a textured, slightly distressed appearance.

SHUENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD.,TIEN CHUNG CHEN,CHANG HWA HSIEN. Taiwan, ROC Tel: [phone] Fax [phone] E-mail:[e-mail] http://www.aeropro.com tw

#### DEVICE DESCRIPTION 6.

#### 6.1 Vision Appearance

#### Product Picture :

We present the N95 Surgical Respirator, type: AP0018 and AP0028, appearance as the following pages.

Note: Relevant specification per Class II (ASTM2100-04 Low Barrier).

## Product Description:

- · SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.
- · Non-Sterilized.
- · For single use.

## Product Directions:

Please refer to the Instruction as the following pages.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol.

JAN - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shuenn Bao Shing Corporation C/O Dr. Ke-Min Jen Official Correspondent ROC Chinese-European Industrial Research Society No. 58, Fu Chiun Street Hsin Chu City CHINA (TAIWAN) 30067

Re: K072067

Trade/Device Name: N95 Surgical Respirators, Type: AP0018, AP0028 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: December 22, 2007 Received: December 31, 2007

Dear Dr. Jen:

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 – 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 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/6/Picture/0 description: The image shows a logo for "AERO PRO". The logo consists of a stylized letter "P" above the words "AERO PRO". The letter "P" is made up of three curved lines that resemble wings. The text "AERO PRO" is in a sans-serif font.

SHUENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD., TIEN CHUNG CHEN,CHANG HWA HSIEN. Taiwan. ROC Tel: [phone] Fax: [phone] E-mail:shuennba(@ms17.hinet.net http://www.aeropro.com.tw

# Indications for Use

012067 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: N95 Surgical Respirator, Type: AP0018, AP0028

Indications for Use:

The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

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)

Murphy MD
Division Sign Off

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

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510(k) Number: K072067