K Number

Device Name

Medical Face Mask

Manufacturer

Shandong Xingyu Gloves Co., Ltd.

Date Cleared

2022-06-28

(57 days)

Product Code

FXX

Regulation Number

878.4040

Intended Use

The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

Device Description

The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

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

K211631

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and physical performance characteristics of a standard medical face mask. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.

Therapeutic

No.
The device is a medical face mask intended to prevent the transfer of microorganisms, body fluids, and particulate material, primarily for infection control. It is not designed to treat, cure, or mitigate a disease or condition, which are characteristic functions of a therapeutic device.

Diagnostic

No
The device is a medical face mask, primarily intended for protection against microorganisms and particulate matter, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene filter, ear loops, nose piece made of metal core plastic) and performance testing related to material properties and physical barriers, 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 mask is for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: The description details the physical construction and materials of the mask, focusing on its barrier properties and fit. There is no mention of any components or mechanisms for analyzing samples or providing diagnostic information.
Performance Studies and Key Metrics: The performance studies and key metrics focus on the mask's ability to filter particles and fluids, its breathability, flammability, and biocompatibility. These are all related to its function as a physical barrier and protective device, not to any diagnostic capability.
Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.) or providing any kind of test result or diagnostic information.

IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This face mask does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19.

Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002;

Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002;

The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

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

Healthcare personnel/Infection control practices

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 tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with standards including ISO 10993-5, ISO 10993-10, ASTM F2100, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, and 16 CFR 1610.

Performance Testing:

Fluid Resistance (ASTM F1862): 3 non-consecutive lots tested, 32 out of 32 per lot pass at 120 mmHg for Level 2 and at 160 mmHg for Level 3. Acceptance Criteria: 29 out of 32 pass at 120 mmHg for Level 2; 29 out of 32 pass at 160 mmHg for Level 3. Result: PASS.
Particulate Filtration Efficiency (ASTM F2299): 3 non-consecutive lots tested, sample size of 32/lot. Average Results: Level 2: 99.2%, Level 3: 99.5%. Acceptance Criteria: ≥ 98%. Result: PASS.
Bacterial Filtration Efficiency (ASTM F2101): 3 non-consecutive lots tested, sample size of 32/lot. Average Results: Level 2: 99.3%, Level 3: 99.3%. Acceptance Criteria: ≥ 98%. Result: PASS.
Differential Pressure (Delta P) (EN 14683 Annex C): 3 non-consecutive lots tested, sample size of 32/lot. Average Results: Level 2: 5.0 mmH2O/cm², Level 3: 4.4 mmH2O/cm². Acceptance Criteria:

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 shows 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.

June 28, 2022

Shandong Xingyu Gloves Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K221272

Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 2, 2022 Received: May 2, 2022

Dear Jarvis Wu:

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 medical devices and radiation-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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 K221272 See PRA Statement below. Page 1 of 1

Submission Number (if known)

K221272

Device Name

Medical Face Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Shandong Xingyu Gloves Co., Ltd. No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China

510(k) Summary K221272

K221272 Page 1 of 7

Document Date Prepared:2022/6/27

A. Applicant:

Name: Shandong Xingyu Gloves Co., Ltd.

Address: No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China

Contact Person: Carrie Li Tel: 0086-18263618867 Mail: carrie@xingyugloves.com

Submission Correspondent:

Primary contact: Mr. Jarvis Wu

Shanghai SUNGO Management Consulting Co., Ltd.

14th floor, 1500# Century Ave., Shanghai 200122, China

Tel: +86-21-58817802

Email: haiyu.wang(@sungoglobal.com

Secondary contact: Mr. Raymond Luo

14th floor, 1500# Century Ave., Shanghai 200122, China

Tel: +86-21-68828050

Email: fda.sungo@@gmail.com

B. Device:

Proprietary Name: Medical Face Mask Common Name: Surgical Face Mask Model(s): M001, M2002, M3001, M3002

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040

Shandong Xingyu Gloves Co., Ltd. No. 2189 Yaoqian Road, Gaomic Development Zone, Weifang City, Shandong Province, China

Review Panel: Surgical Apparel

K221272 Page 2 of 7

C. Predicate device:

| 510K | Device name | ASTM F2100-19
level | Manufacturer |
|---------|--------------------|------------------------|---------------------------------------------------|
| K211631 | Surgical Face Mask | Level 2 & 3 | Macheng thimble Technology
Investment Co., Ltd |

(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)

D. Indications use of the device:

E. Device Description:

The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19.

Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002;

Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002;

F. Comparison with predicate device

Table 1 General Comparison

Device	Proposed Device	Predicate device	Comparison

Manufacturer		Shandong Xingyu Gloves Co.,
Ltd.	Macheng thimble
Technology Investment
Co., Ltd	-
510K number		K221272	K211631	-
Device name		Medical Face Mask	Surgical Face Mask	-
Classification		Class II Device, FXX (21
CFR878.4040)	Class II Device, FXX (21
CFR878.4040)	Same
Indications for use		The Medical Face Mask is
intended to be worn to protect
both the patient and healthcare
personnel from transfer of
microorganisms, body fluids and
particulate material. These face
masks are intended for use in
infection control practices to
reduce the potential exposure to
blood and body fluids. This a
single use, disposable device(s),
provided non-sterile.	The Surgical Face Masks are
intended to be worn to protect
both the patient and healthcare
personnel from transfer of
microorganisms, body fluids
and particulate material.
These face masks are intended
for use in infection control
practices to reduce the
potential exposure to blood
and body fluids. This a single
use, disposable
device(s), provided non-sterile.	Same
Material	Outer
layer	Non-woven fabric	Spun-bond polypropylene	Same
	Middle
layer	Melt-blown Non-woven fabric	Melt blown polypropylene filter	Same
	Inner layer	Non-woven fabric	Spun-bond polypropylene	Same
	Nose clip	Metal Core Plastic
(Iron wire & Polypropylene)	Malleable aluminum wire	substantially
equivalent
	Ear loops	Polyester and Spandex	Polyester	substantially
equivalent
Color		Blue, Black	Blue	substantially
equivalent
Dimension			17.5cm+/-0.5cm	substantially
equivalent

(length)	175mm+/-5mm		Same
Dimension
(Width)	95mm+/-5mm	9.5cm+/-0.5cm	Same
OTC use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100-19
level	Level 2 & 3	Level 2 & 3	Same
Biocompatibility	Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing	Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing	Same

K221272

K221272 Shandong Xingyu Gloves Co., Ltd. Page 4 of 7 No. 2189 Yaoqian Road, Gaomic Development Zone, Weifang City, Shandong Province, China

From the comparison we found the material of proposed device's nose clip and Ear loops, as well as its color, are different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-10. There is no new risk generated from the difference of the material.

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
ASTM F1862, 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, Medical Face Masks-Requirements and Test Methods;
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of > Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
A ASTM F2299, Stand test method for determining the initial efficiency of materials used in

Shandong Xingyu Gloves Co., Ltd. No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China

medical face masks to penetration by particulates using latex spheres;

K221272 Page 5 of 7

16 CFR 1610, Standard for the Flammability of clothing textiles;
Table 2 - Performance Testing

| Item | Proposed device | | Acceptance
Criteria | Result |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------|
| Fluid Resistance
Performance
ASTM F1862 | Assess the
performance of a
mask to resistance
to a synthetic
blood preparation
targeted toward
the mask at a set
pressure | 32 out of 32 per
lot pass at 120
mmHg for 3
non-consecutive
lots tested;

32 out of 32 per
lot pass at 160
mmHg for 3
non-consecutive
lots tested; | 29 out of 32 pass at
120 mmHg for
Level 2

29 out of 32 pass at
160 mmHg for
Level 3 | PASS |
| Particulate
Filtration
Efficiency ASTM
F2299 | Assess the
performance of
a mask to
penetration by
sub-micron
polystyrene
latex particles of
0.1 micron | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Average Result-
Level 2 : 99.2%
Level 3 : 99.5% | ≥ 98% | PASS |
| Bacterial
Filtration
Efficiency ASTM
F2101 | Assess the
performance of
a mask to
penetration by a
prepared solution
with known
concentration of
an indicator
bacterial
organism | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Average Result-
Level 2 : 99.3%
Level 3 : 99.3% | ≥ 98% | PASS |

Shandong Xingyu Gloves Co., Ltd.

K221272 No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China

Page 6 of 7

| Differential
Pressure (Delta P)
EN 14683 Annex
C | Assess the
performance of
a mask for
resistance to
air movement
through the
materials of the
face of the mask | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Average Result-
Level 2 : 5.0
mmH2O/cm²
Level 3 : 4.4
mmH2O/cm² |