K Number

Device Name

Disposable Medical Surgical Mask

Manufacturer

Hubei Huaqiang High-Tech Co., Ltd.

Date Cleared

2022-03-23

(208 days)

Product Code

FXX

Regulation Number

878.4040

Intended Use

Device Description

The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided sterile. The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric. The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex. The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire. The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K202904

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.

Therapeutic

No
The device is described as a mask intended for protection against the transfer of microorganisms, body fluids, and particulate material, not for treating a disease or condition.

Diagnostic

No
The device, a Disposable Medical Surgical Mask, is intended for protection from microorganisms and body fluids, and for infection control, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like polypropylene fabric, ear loops, and a nose piece, 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 that the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
Device Description: The description details the physical construction and materials of the mask, which are consistent with a barrier device, not a diagnostic tool.
Lack of Diagnostic Elements: There is no mention of reagents, assays, or any components designed to analyze biological samples or provide diagnostic information.
Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility), not on the accuracy or reliability of a diagnostic test.

IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This surgical mask does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FXX

Device Description

The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric.

The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex.

The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire.

The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.

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

Not Found

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 Conclusion: The test results demonstrated that the proposed device complies with the following standards:

ISO 11135-2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For Irritation > And Skin Sensitization.
ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
EN 14683-2019+AC:2019 Annex C, Medical face masks – Requirements and test methods;
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency A (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
16 CFR 1610, Standard for the Flammability of clothing textiles;

Test Results:

ASTM F1862 (Resistance to penetration by synthetic blood): 120 mm Hg (Acceptance Criteria: 120 mm Hg)
ASTM F2299 (Sub-micron particulate filtration efficiency at 0.1 micron): ≥ 98% (Acceptance Criteria: ≥ 98%)
ASTM F2101 (Bacterial Filtration Efficiency): ≥ 99% (Acceptance Criteria: ≥ 98%)
EN 14683 Annex C (Differential Pressure):

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 23, 2022

Hubei Huaqiang High-Tech Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District, Beijing 102401 China

Re: K212726

Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 8, 2022 Received: March 11, 2022

Dear Ray Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212726

Device Name Disposable Medical Surgical Mask

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K212726

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: 2022/03/23
1. Sponsor Identification

Hubei Huaqiang High-Tech CO., LTD. No.499 DongLin Road, Yichang, Hubei Province, 443000, China

Contact Person: Jing Yang Position: Vice Director of Tech Center Tel: +86-13545751006 Fax: +86-717-6347336 Email: 409281039@gq.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com

1. Identification of Proposed Device
  Trade Name: Disposable Medical Surgical Mask Common Name: Mask, Surgical

Regulatory Information Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: General Hospital

Indication for use Statement:

Device Description

The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric.

The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex.

The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.

1. Identification of Predicate Device(s)
  510(k) number: K202904 Device Name: Surgical Face Mask Manufacturer: Jiangxi Feilikang Medical Technology Co., Ltd.

Technological Characteristics Comparison 6.

Table 1 General Comparison

ITEM	Proposed Device K212726	Predicate Device K202904	Remark
	ASTM F2100 Level 2	ASTM F2100 Level 2
Intended Use /
Indication for Use		The Disposable Medical Surgical Mask
is intended to be worn to protect both
the patient and healthcare personnel
from the transfer of microorganisms,
body fluids, and particulate material.
The Disposable Medical Surgical Mask
is intended for use in infection control
practices to reduce the potential
exposure to blood and body fluids. This
is a single-use, disposable device(s),
provided sterile.	Surgical Face Mask is intended for
single use by operating room personnel
and other general healthcare workers to
protect both patients and healthcare
workers against transfer of
microorganisms, blood and body fluids,
and particulate materials.	Similar
Basic Design		Ear Loops, Flat Pleated, 3 layers	Ear Loop, Flat-pleated, 3 layers	SAME
Materials	Outer Facing
Layer	polypropylene spunbond fabric	Polypropylene Non-Woven Fabric	Differences
addressed by
performance
	Middle Layer	polypropylene melt-blown fabric	Polypropylene Melt-Blown Fabric
	Inner Facing Layer	polypropylene spunbond fabric	Polypropylene Non-Woven Fabric	and
	Nose Piece	polypropylene and metal wire	Polypropylene and Iron Wire	biocompatibility
	Ear Loops	nylon or spandex	Nylon and Spandex	testing


Color		Blue	Blue	SAME
Dimension (Length)		$17.5 \pm 5%$ cm	17.5 cm	SAME
Dimension (Width)		$9.5 \pm 5%$ cm	9.5 cm	SAME
OTC use		Yes	Yes	SAME
Single Use		Yes	Yes	SAME
Sterile		Sterile	Sterile	SAME
Sterilization method		EO	EO	SAME
Sterilization residues		EtO and ECH residues meet the
requirements of ISO 10993-7	EtO and ECH residues meet the
requirements of ISO 10993-7	SAME
Shelf Life		2 years	Unknown	Difference
addressed
by
Shelf-Life
validation
Packaging		10 pcs/bag	Unknown	SAME
Packaging
Configuration and
materials		Medical dialysis paper (Tyvek) and PP
(polyethylene and polypropylene) film.

Table 2 Performance Characteristic Comparison

| ITEM | Proposed Device
K212726 | Predicate Device
K202904 | ASTM F2100
Requirements | Remark |
|-----------------------------------------------|----------------------------|-----------------------------|----------------------------|--------------------------------------|
| ASTM F2100 Level | Level 2 | Level 2 | Level 2 | SAME |
| Fluid Resistance
Performance ASTM
F1862 | 120 mmHg | 120 mmHg | 120 mmHg | Both meet
requirements.
No new |
| Particulate Filtration | ≥98% | Average 98.74% at | ≥ 98% | issues of |

| Efficiency ASTM
F2299 | | 0.1 µm | | safety or
effectiveness |
|-------------------------------------------------------------------------|----------------|----------------------|-----------------|----------------------------|
| Bacterial Filtration
Efficiency ASTM
F2101 | ≥99% | Average 99.65% | ≥ 98% | |
| Differential Pressure
(Delta P)
EN 14683-2019
+AC:2019 Annex C | ISO 11135-2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 10993-5: 2009 Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For Irritation > And Skin Sensitization.
ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
EN 14683-2019+AC:2019 Annex C, Medical face masks – Requirements and test methods;
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency A (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;

Test Method	Purpose	Acceptance Criteria	Results
ASTM F1862	Resistance to penetration by synthetic blood	120 mm Hg	120 mm Hg
ASTM F2299	Sub-micron particulate filtration efficiency at 0.1 micron	≥ 98%	≥ 98%
ASTM F2101	Bacterial Filtration Efficiency	≥ 98%	≥ 99%
EN 14683
Annex C	Differential Pressure	16 CFR 1610, Standard for the Flammability of clothing textiles;

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Conclusion
  The conclusions drawn from the nonclinical tests demonstrate that the subject device, K212726, Disposable Medical Surgical Mask, is as safe, as effective, and performs as well as or better than the legally marketed device, K202904, Surgical Face Mask by Jiangxi Felikang Medical Technology Log., Ltd.