The Disposable surgical masks are intended to be worn to protect 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 is a single use, disposable device(s), provided non-sterile.

Device Description

The Disposable surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for a "Disposable surgical mask" (K220532), demonstrating its substantial equivalence to a predicate device. The clearance is based on non-clinical performance testing.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test Item	Acceptance Criteria	Reported Device Performance	Result
Fluid Resistance (ASTM F1862)	29 out of 32 pass at 120 mmHg	3 non-consecutive lots tested: All passed (implied)	Pass
Particulate Filtration Efficiency (ASTM F2299)	≥ 98%	Lot1: 98.43%, Lot2: 98.18%, Lot3: 98.54%	Pass
Bacterial Filtration Efficiency (ASTM F2101)	≥ 98%	Lot1: 99.9%, Lot2: 99.9%, Lot3: 99.9%	Pass
Differential Pressure (MIL-M-36954C)	< 5.0mmH2O/cm²	Lot1: 3.5mmH2O/cm², Lot2: 3.1mmH2O/cm², Lot3: 3.3mmH2O/cm²	Pass
Flammability (16 CFR 1610)	Class 1	Class 1	Pass
Irritation	Non-irritating	Under the conditions of the study, the device is non-irritating	Pass
Sensitization	Non-sensitizing	Under the conditions of the study, the device is non-sensitizing	Pass
Cytotoxicity	Non-cytotoxic	Under the conditions of the study, the device is non-cytotoxic	Pass

2. Sample sized used for the test set and the data provenance

Sample Size: For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, "3 non-consecutive lots tested" were used. The number of individual masks tested within each lot is not specified, except for Fluid Resistance where "29 out of 32" suggests 32 samples were tested per lot for that specific test.
Data Provenance: The tests were conducted by the manufacturer, Xiamen Blue Star Enterprise Co., Ltd., China. The document does not specify if the data is retrospective or prospective, but it's generated for the purpose of this 510(k) submission, suggesting it's newly generated for regulatory approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this document. The device in question is a physical product (surgical mask), and its performance is evaluated through standardized laboratory tests (e.g., filtration efficiency, fluid resistance) rather than through expert interpretation of medical images or other data where a "ground truth" would be established by human experts. The "ground truth" here is the objective measurement of the physical properties of the mask.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where discrepancies need to be resolved. This document details laboratory performance testing of a physical product.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This document describes the clearance of a physical medical device (surgical mask), not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by objective, standardized laboratory test methods. Examples include:

ASTM F1862 for fluid resistance.
ASTM F2299 for particulate filtration efficiency.
ASTM F2101 for bacterial filtration efficiency.
MIL-M-36954C (or EN 14683) for differential pressure.
16 CFR 1610 for flammability.
ISO 10993-5 and -10 for biocompatibility (irritation, sensitization, cytotoxicity).

8. The sample size for the training set

This section is not applicable. A "training set" refers to data used to train machine learning models. This document describes a physical medical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as #8.

Summary

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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.

May 23, 2022

Xiamen Blue Star Enterprise Co., Ltd. % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co.,Ltd. 609 Room,No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China

Re: K220532

Trade/Device Name: Disposable surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 5, 2021 Received: February 24, 2022

Dear Sam Lin:

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

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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,

for

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

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Indications for Use

510(k) Number (if known) K220532

Device Name Disposable surgical mask

Indications for Use (Describe)

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

Research Use (21 CFR 201.26)	Sample Use (21 CFR 201.26)
-------------------------------------------------------	----------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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Type of submission	Traditional
Date prepared	July 5, 2021
Submission sponsor
Manufacturer Name	Xiamen Blue Star Enterprise Co., Ltd.
Address	Room 201, South Building, No.506, Haiming Road,
	Maxiang Town, Xiang'an District, Xiamen, China
Tel	86-13015920500
Email	13015920500@163.com
Contact Person	Jincong Zhang
Device identification
Trade Name	Disposable surgical mask
Regulation Number	21 CFR 878.4040
Regulation Name	Mask, Surgical
Device Classification	Class II
Product Code	FXX
Panel	General Hospital
Previous Submissions	None
Application correspondent
Company Name	Shanghai Spica Management Consulting Co., Ltd.
Address	609 Room, No.133 Shengang Avenue, Pudong New
	District, Shanghai, China
Tel	86-18717927910
Email	sam@spicagloble.com
Contact Person	Sam Lin

Page 1 of 8 K220532

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Predicate device information

Sponsor	WUHAN DYMEX HEALTHCARE CO., LTD.
Trade/Device Name	SURGICAL FACE MASK
510(K) number	K182515
Regulation Number	21 CFR 878.4040

Indications for use

The Disposable surgical 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 is a single use, disposable device(s), provided non-sterile.

Device description

Performance Testing - Clinical

Not Applicable.

Performance Testing - Animal

Not Applicable.

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510(K) Summar

echnological Characteristic Compariso

Provided below is a comparison of the subject device with the predicate device

able 6A: General Compariso

	Proposed Device	Predicate Device	Differences
			Discussion
Device name	Disposable surgical mask	SURGICAL FACE MASK	N/A
510(k) number		K182515	N/A
Manufacturer	Xiamen Blue Star Enterprise Co., Ltd.	Wuhan Dymex Healthcare Co., Ltd	N/A
Product regulation	21 CFR 878.4040	21 CFR 878.4040	Same
Classification name	Mask, Surgical	Mask, Surgical	Same
Regulation class	2	2	Same
Product code	FXX	FXX	Same
Indications for use	The Disposable surgical masks are intended to beworn to protect both the patient and healthcarepersonnel from transfer of microorganisms, bodyfluids and particulate material. These face masks	The Surgical Face Masks are intended to be wornto protect both the patient and healthcare personnelfrom transfer of microorganisms, body fluids andparticulate material. These face masks are intended	Same
	Rx or OTC
	are 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 non-sterile.	are intended for use in infection control practices 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 non-sterile.	Same
	OTC	OTC	Same
	Model
	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Flat Pleated, 3 layers	Same
Material
Outer facing layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
Middle layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
Inner facing layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
Nose clip	Polyethylene	Malleable polyethylene wire	Similar
Ear loops	Spandex	Spandex	Same
Color	Blue	Blue	Same
Dimension	17cm X 9.5cm	17.5cm X 9cm	Similar
Sterility	Non-Sterile	Non-Sterile	Same

Page 3 of 8
K220532

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510(K) Summary

Page 4 of 8
K220532

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Use	Single Use, Disposable		Single Use, Disposable
Summary of Non-Clinical Testing
Provided below is a summary of the performance testing of the subject devices to demonstrate that the device meets the specification or acceptance criteria of the standards and test methods shown below.
Table 6B: Comparison of Non-clinical testing
Item		Proposed device	Acceptance Criteria	Result
FluidASTM F1862	Resistance	Performance 3 non-consecutive lots tested	29 out of 32 pass at 120 mmHg	Pass
ParticulateASTM F2299	Filtration	Efficiency 3 non-consecutive lots testedLot1: 98.43%Lot2: 98.18%Lot3: 98.54%	≥ 98%	Pass
BacterialASTM F2101	Filtration	Efficiency 3 non-consecutive lots testedLot1: 99.9%Lot2: 99.9%Lot3: 99.9%	≥ 98%	Pass
DifferentialMIL-M-36954C	Pressure (Delta P)	3 non-consecutive lots testedLot1: 3.5mmH2O/cm²Lot2: 3.1mmH2O/cm²	< 5.0mmH2O/cm²	Pass

510(K) Summary

Level 2

Level

Similar

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510(K) Summary
	Lot3: 3.3mmH2O/cm²
Flammability 16 CFR 1610	Class 1	Class 1	Pass
Irritation	Under the conditions of the study, the device is non-irritating	Under the conditions of the study, the device is non-irritating	Pass
Sensitization	Under the conditions of the study, the device is non-sensitizing	Under the conditions of the study, the device is non-sensitizing	Pass
Cytotoxicity	Under the conditions of the study, the device is non-cytotoxic.	Under the conditions of the study, the device is non-cytotoxic.	Pass
Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of

0(K) Summa

xed Volume at a Known Veloci
- ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Face Masks ration by Particulates using Latex Sphere ●
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Usin Biological Aerosol of Staphylococcus aureu ●

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fferential Pressure -Determine breathing resistance or differential pressure as directed in EN 14683:2019, Annex
M F2100-2019 Standard Specification for Performance of Materials Used in Medical Face Mas ●
0993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotox ●
10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitizatio .

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Conclusion

Based on the indications for use, general information, and non-clinical performance data, "Disposable surgical mask" is as safe, as effective, and performs as well as the legally marketed predicate devices, "SURGICAL FACE MASK (K182515)". Therefore, the subject device is substantially equivalent to the predicate device.

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.