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

• K Number: K080827
• Device Name: HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
• Manufacturer: HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L
• Date Cleared: 2008-04-04 ( 10 days)
• Product Code: MSH
• Regulation Number: 878.4040

Intended 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 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. Handan 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.

Predicate Devices

K041855, K960778

Reference Devices

K960778, K041855

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical construction and filtration capabilities of the respirators/masks, with no mention of AI or ML technology.

Therapeutic

No
The description states the device is intended for protection from transfer of microorganisms, blood and body fluids, and airborne particulate materials, not for treatment or diagnosis of a disease or condition.

Diagnostic

No

This device is a particulate respirator and surgical mask, designed to protect users from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. It does not perform any diagnostic functions or analyze patient information to provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like polypropylene spunbond, melt blown filter media, polyester filter fabric, head straps, and a PU foam nosepiece, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for protecting healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
• Device Description: The description details the materials and construction of a mask, which is a physical barrier.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro to diagnose a condition or provide information about a patient's health status.
• Performance Studies: The performance studies focus on the physical properties and filtration capabilities of the mask (resistance, filtration efficiency, flammability, biocompatibility), which are relevant to its function as a protective barrier, not an IVD.

IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

Product codes

MSH

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.
Handan 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel or general health care workers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Test Performed for Determination of Substantial Equivalence:

• 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

Performance testing meet all relevant requirements of the aforementioned test standard.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K041855, K960778

Reference Device(s)

FXX, 878, 4040. Class II

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.

Summary

0

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

1

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

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

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

2

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.

3

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.

4

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

5

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