HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810

K080827 · Handan Hengyong Protective & Clean Products Co., L · MSH · Apr 4, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080827
• Device Name: HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
• Applicant: Handan Hengyong Protective & Clean Products Co., L
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Apr 4, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

The Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

Device Story

Handan HY8510 and HY9810 are N95 particulate respirators and surgical masks; intended for single-use by healthcare personnel. HY8510 is a flat-pleated mask with single elastic head strap; HY9810 is a molded cup mask with dual elastic head straps. Both utilize multi-layer filtering media (polypropylene spunbond, melt-blown polypropylene, polyester) and include a PU foam nosepiece with plastic/steel wire. Devices function as physical barriers to protect patients and clinicians from microorganisms, body fluids, and airborne particulates. Used in clinical settings including operating rooms, isolation units, and dental offices. No sterilization; single-use only.

Clinical Evidence

No clinical data. Bench testing only, including NIOSH exhalation/inhalation resistance tests, NIOSH sodium chloride (NaCl) N95 filtration testing, 16 CFR 1610 flammability testing, and ISO 10993 biocompatibility testing.

Technological Characteristics

N95 particulate respirator; multi-layer construction (polypropylene spunbond, melt-blown polypropylene, polyester); PU foam nosepiece with plastic/steel wire; elastic head straps; non-sterile; single-use. NIOSH certified (TC-84A-4276, TC-84A-4521).

Indications for Use

Indicated for operating room personnel and health care workers for protection against microorganisms, blood, body fluids, and airborne particulates; includes use as procedure, isolation, or dental face mask; meets CDC guidelines for TB exposure control.

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

• Pleated plus 1050 and 1050S (K041855)
• APR Type N95 model 2735 (K960778)

Submission Summary (Full Text)

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### Handan Hengyong Protective &Clean Proc

1-1 1201, 455 Gongnong Road, Shijiazhuang, Hebei, P.R.China Tel: [phone] Fax: [phone]

APR - 4 2008

Page 1 of 3

# 510(k) Summary

This summary of 510K safety and effectiveness information is being submitted in accrodance with the requirements of 21 CFR 807.92.

The assigned 510K number is K080827

1. Submitter's Identification:

Handan Hengyong Protective & Clean Products Co.,Ltd

1-1-1201,455 Gongnong Road, Shijiazhuang,

Hebei Province, P.R.China

Contact:

Maggie Zhong Tel:[phone] Fax:[phone] Mail: [e-mail] Date of Summary: April 2, 2008

- 2. Device Name:
Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810

- 3. Classification Name: Surgical N95 Mask
- 4.. Device Description

Handan HY8510 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the inner and outer cover. The polypropylene melt blown filter media and polyester filter fabric are layered between the inner and outer cover. The head strap is made of polyester elastic(for single head strap) which is circled to the mask. The inside nosepiece is a PU foam.

I landan HY9810 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the outer cover, polyester filter fabric used in the inner cover. The polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of polyester elastic(for double headband) which is welded to the mask. The inside nosepiece is a PU foam.

Both items are no - sterilized and only for single use.

- 5. Intended Use:
Handan type N95 respirators are intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. These would include use as procedure mask, isolation mask or dental face mask.

- 6. Comparison to Predicate Devices

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## Handan Hengyong Protective &Clean Products Co.,Ltd

1-1 1201, 455 Gongnong Road, Shijiazhuang, Hebei, P.R.China Fax: [phone] Tel: [phone]

Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810 are substantially equivalent is safety and effectiveness to the predicate device. Aearo Company-- K041855 Pleated plus 1050 and 1050S Gerson Isolair Compay - k960778 APR Type N95 model 2735 for reference: FXX, 878, 4040. Class II

| Manufacturer | Handan Hengyong Protective & Clean<br>Products Co.,Ltd | Aearo Company<br>Predicate device-for reference |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | HY8510 N95 Surgical Mask<br>(New device) | Pleated plus 1050 and 1050S |
| 510K<br>Number | K080827 | K041855 |
| Product code | MSH, 878.4040 | SAME |
| Device<br>Description | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(white polypropylene spundbond,<br>polypropylene, meltblown, polyester,<br>polypropylene)<br>3. Plastic nose wire with steel<br>4. White elastic headband<br>5. Dimension<br>15.5" circumference<br>6. Flat pleated mask<br>7. Single elastic head strap | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(White spundbond polypropylene,<br>meltblown polypropylene)<br>3. Tic wire nose piece<br>4. White elastic headband<br>5. Dimension<br>Small (13.5" circumference)<br>Large(15.5" circumference)<br>6. Flat pleated mask<br>7. Dual elastic head strap |
| NIOSH<br>certification# | TC-84A-4276 | TC-84A-2630 |

| Manufacturer | Handan Hengyong Protective & Clean<br>Products Co.,Ltd | Gerson Isolair APR Company<br>Predicate device-for reference |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | HY9810 N95 Surgical Mask<br>(New device) | N95 model 2735 |
| 510K<br>Number | K080827 | K960778 |
| Product code | MSH, 878.4040 | SAME |
| Device<br>Description | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(white polyester, polypropylene<br>meltblown, polypropylene)<br>3. Plastic nose wire with steel<br>4. White elastic headband<br>5. Dimension<br>15.75" circumference<br>6. Molded Cup<br>7. Dual elastic head strap | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(White nonwoven polyester<br>meltblown polypropylene)<br>3. Plastic nose wire<br>4. Yellow elastic, latex free<br>5. Dimension<br>Small (13.75" circumference)<br>6. Molded Cup<br>7. Dual elastic head strap |
| NIOSH<br>certification# | TC-84A-4521 | TC-84A-160 |

Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence

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## Handan Hengyong Protective &Clean Products Co.,Ltd

1-1 1201, 455 Gongnong Road, Shijiazhuang, Hebei, P.R.China Fax: [phone] Tel: [phone]

#### are as follows:

- NIOSH, Exhalation of Resistance Test, 84.180 I.
- NIOSH Inhalation of Resistance Test, 84.180 ][.
- NIOSH Sodium Chloride (Nacl) -N95 84.181 III.
- Flammibility, Complied with 16 CFR 1610 Class I, IV.
- V. Biocompatibility per ISO 10993

It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard.

#### Disscussion of Clinical Tests Performed

Not Applicable

- 7. Conclusions
Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810 has the same intended use and technology characterisitics as the predicate devices (K041855, K960778). Moreover, the bench testing contained in this submission supplied domonstrate that the technological characterisistics do not raise any new question of safety or effectiveness.

Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810 are 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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2008

Ms. Maggie Zhong Consultant Handan Hengyong Protective & Clean Products Company, Limited 1-1 1201, 455 Gongnong Road, Shijiazhuang Hebei Province P.R.CHINA

Re: K080827

Trade/Device Name: Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 Surgical N95 Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: March 15, 2008 Received: March 25, 2008

Dear Ms. Zhong:

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 - Ms. Zhong

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): APPLICANT: DEVICE NAME:

080827 Handan Hengyong Protective & Clean Products Co.,Ltd Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 Surgical N95 Respirator

INDICATION FOR USE:

The Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

Prescription Use __ (Part 21 CFR 801 Subpart D)

ア Over-The-Counter Use AND/OR (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)

Clue

Page 1 of _

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080827