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

Device Description

The Surgical Face Masks are single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Face Masks are 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 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 plastic wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Surgical Face Mask (K201545) manufactured by Amphastar Nanjing Pharmaceuticals, Inc. The device's acceptance criteria and the study proving it meets these criteria are outlined in the non-clinical performance testing section.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against specific ASTM and EN standards for surgical face masks.

Item(s)	Acceptance Criteria	Reported Device Performance (K201545)	Result
Resistance to penetration by synthetic blood (ASTM F1862)	29 out of 32 pass in 120 mm Hg	32 out of 32 passed in 120 mm Hg	Pass
Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299)	≥98%	>98%	Pass
Bacterial filtration efficiency (ASTM F2101-19)	≥98%	>98%	Pass
Differential pressure (EN 14683:2019)	< 6.0 mm H2O/cm2	≤ 3.0 mm H2O/cm2	Pass
Flame spread (16 CFR 1610)	Class 1	Class 1 (Non Flammable)	Pass

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- For Resistance to penetration by synthetic blood (ASTM F1862), the test required 32 samples, and the reported performance indicates "32 out of 32 passed."
- For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flame Spread), specific sample sizes are not explicitly stated within the provided extract beyond the reported percentage or value. However, the nature of these tests implies that sufficient samples were tested to achieve the reported values.
Data Provenance: The document does not explicitly state the country of origin for the test data (e.g., where the testing labs are located) or whether the data was retrospective or prospective. Given the manufacturer is based in China, it's plausible the testing was conducted in China or by accredited labs elsewhere. The tests are "non-clinical tests performed on the proposed device," indicating they were specifically conducted for this submission (prospective in relation to the submission).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This device is a surgical face mask, and its performance evaluation relies on standardized physical and material property tests, not on expert interpretation of medical images or clinical outcomes. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for medical imaging) is not applicable here. The ground truth is established by the results of the specified laboratory tests adhering to recognized standards (ASTM, EN, CFR).

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human reviewers, such as in clinical trials or medical imaging assessments, to resolve disagreements.
Since the evaluation of this device is based on objective laboratory performance testing against established technical standards, there is no human-in-the-loop adjudication process described or required for the test results. The pass/fail criteria are based on quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or is relevant for this device. An MRMC study is used to assess the effectiveness of an AI system, often in diagnostic imaging, by comparing the performance of multiple human readers with and without AI assistance across multiple cases.
This submission is for a physical medical device (surgical face mask), whose effectiveness is determined by its physical and material properties (filtration, breathability, fluid resistance, flame resistance), not by diagnostic interpretation or human-AI interaction.

6. Standalone (Algorithm Only) Performance

Not applicable. This section typically relates to artificial intelligence or machine learning algorithms. The device in question is a physical surgical face mask; therefore, there is no "algorithm only" performance to be assessed. The performance is the inherent property of the physical device.

7. Type of Ground Truth Used

The ground truth for the device's performance is established by objective, quantitative measurements obtained from standardized non-clinical laboratory tests. These tests assess physical properties like filtration efficiency, fluid resistance, breathability, and flammability. The acceptance criteria are derived directly from these technical standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101-19, EN 14683:2019, 16 CFR 1610).

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set. The manufacturing process and material selection are based on established engineering principles and quality control, not on a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device like a surgical face mask.

Summary

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February 12, 2021

Amphastar Nanjing Pharmaceuticals, Inc. Bob Bao Quality Management Representative No.5 Xinghe Road, Nanjing Economic and Technological Development Zone Nanjing, Jiangsu 210038 China

Re: K201545

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 1, 2020 Received: June 9, 2020

Dear Bob Bao:

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.

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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 and Part 809); 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 (OS) 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 CAPT Elizabeth Claverie, M.S. 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201545

Device Name Surgical Face Mask

Indications for Use (Describe)

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

_ 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

K201545

Date Summary Prepared: 2021-01-06

A. Applicant:

Amphastar Nanjing Pharmaceuticals, Inc. Address: No. 5 Xinghe Road, Nanjing Economic and Technological Development Zone. Jiangsu, China 210038 Contact Person: Bob Bao, Representative of Quality System Management Tel: 86-025-85807880-211 Fax: 86-025-85802275 E-mail: bobb@amphastar.cn FDA Registration Number: 3009805706

B. Device:

Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Model(s): Ear Loop

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

C. Predicate de vice:

K182515 Surgical Face Mask Wuhan Dymex Healthcare Co.,Ltd

D. Indications for Use:

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the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

E. Device Description:

Item(s)	Proposed Device (K201545)	Predicate (K182515)	Comparison
	Surgical Face MaskASTM Level 2	Surgical Face MaskASTM Level 2
Manufacturer	Amphastar Nanjing Pharmaceuticals,Inc.	Wuhan Dymex Healthcare Co., Ltd	-
510K number	K201545	K182515	-
Model Name	Surgical Face Mask	Surgical Face Mask	Same
Classification	Class II Device, FXX (21CFR878.4040)	Class II Device, FXX (21CFR878.4040)	Same
Item(s)	Proposed Device (K201545)Surgical Face MaskASTM Level 2	Predicate (K182515)Surgical Face MaskASTM Level 2	Comparison
Intended Use	The Surgical Face Masks are intendedto be worn to protect both the patientand healthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material. Theseface masks are intended for use ininfection control practices to reducethe potential exposure to blood andbody fluids. This is a single use,disposable device(s), providednon-sterile.	The Surgical Face Masks areintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids and particulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile.	Same
Model	Ear Loops, Flat Pleated, 3 layers	Ear Loops, Flat Pleated, 3 layers	Same
Material	Outer FacingLayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	MiddleLayer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
	Inner FacingLayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Nose Piece	Plastic wire	Malleable aluminum wire	Different
	Ear Loops	Spandex	Spandex	Same
Color		Blue	Yellow	Different
Dimension (Width)		9.5cm (±5%)	9.5cm ±0.2 cm	Same
Dimension (Length)		17.5cm (±5%)	17.5cm±0.2 cm	Same
Dimension (Nose Piece)		9 cm ± 5%	9 cm ± 5%	Same
Dimension (Ear Loops)		15 cm ± 5%	15 cm ± 5%	Same
OTC use		YES	YES	Same
Sterility		Non-Sterile	Non-Sterile	Same
Item(s)	Proposed Device (K201545)	Predicate (K182515)	Comparison
	Surgical Face MaskASTM Level 2	Surgical Face MaskASTM Level 2
Use	Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100 Level	Level 2	Level 2	Same
Biocompatibility
Cytotoxicity	Under the conditions of the study, thedevice is non-cytotoxic	Same	Same
Skin Sensitization Test	Under the conditions of the study , thedevice is non-sensitizing	same	Same
Skin Irritation Test	Under the conditions of the study thedevice is non-irritating	Same	Same

Table 1 General Comparison

F. Summary of Technological Characteristic

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G. Non-clinical Test performed on the proposed device

The proposed devices were tested and conformed to 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.

Table 2 Performance Testing

Item(s)	Proposed Device(K201545)	Predicate(K182515)	AcceptanceCriteria	Result
Resistance topenetration by syntheticbloodASTM F1862	32 out of 32 passedin 120 mm Hg	32 out of 32 passed in120 mm Hg	29 out of 32pass in 120 mmHg	Pass
Sub-micron particulatefiltration efficiency at0.1 micronASTM F2299	>98%	99.7%	≥98%	Pass
BacterialfiltrationefficiencyASTM F2101-19	>98%	99.9%	≥98	Pass
Differential pressureEN 14683:2019	≤ 3.0 mm H2O/cm2	4.0 mm H2O/cm2	< 6.0	Pass

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Item(s)	Proposed Device (K201545)	Acceptance Criteria	Result
Flame spread	Class 1	Class 1	Pass
16 CFR 1610	Non Flammable

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated K182515, Wuhan Dymex Medical Products Surgical Face Mask.

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.