Predicate Devices

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 face mask, with no mention of AI or ML technologies.

Therapeutic

No.
The device description and intended use clearly state that the surgical face mask is for protection against transfer of microorganisms and particulate materials, not for treating any specific condition or disease.

Diagnostic

No

Explanation: The device is a surgical face mask intended to protect against the transfer of microorganisms, blood, and body fluids. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, multi-layer mask made of nonwoven polypropylene with ear loops/ties and a nose clip. There is no mention of software components.

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, blood, body fluids, and particulate materials. This is a barrier function, not a diagnostic function.
Device Description: The description details the physical construction and materials of a face mask. There is no mention of components or processes related to analyzing samples from the human body (which is the core of IVD).
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents
- Assays
- Sample collection or analysis
- Detection of specific analytes or markers
- Diagnostic results or interpretations

The device is a physical barrier intended for personal protection in a healthcare setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 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.

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

FXX

Device Description

The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user, which was provided in following table. The proposed device can be provided in sterile and non-sterile two types.

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 and other general healthcare 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 tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity;
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization;
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
EN 14683: 2019 Medical face masks- Requirements and test methods
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals.

The proposed device meets the requirements of Level 2 mask for particulate filtration efficiency, bacterial filtration efficiency, and differential pressure. The sterilization process was validated per ISO 11135 and found effective. Biocompatibility tests showed the proposed device's extract was non-cytotoxic, non-sensitizing, and non-irritating.

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

Particulate filtration efficiency: Average 98.98%
Bacterial filtration efficiency: Average 98.92%
Differential pressure: Average 4.4 mmH2O/cm^2
Fluid resistance: Pass at 120mmHg
Flammability: Class 1

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173062

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

January 12, 2021

B.J.ZH.F.Panther Medical Equipment Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China

Re: K202843

Trade/Device Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 21, 2020 Received: August 17, 2020

Dear Diana Hong:

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

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) K202843

Device Name

Surgical Face Masks (Non-sterile), Surgical Face Masks (Sterile)

Indications for Use (Describe)

The 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.

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202843

1. Date of Preparation: 01/12/2021
1. Sponsor Identification

B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD

Floor 3, Building 1, 28 Huoju Street, Changping Science and Technology Park, Changping District, 102200 Beijing, China.

Establishment Registration Number: 3008388437.

Contact Person: Jiahui Li Position: International Regulatory Affair Tel: +86-10-80789058-6107 Fax: +86-10-69707402-8068 Email: jiahui.li@pantherhealthcare.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) Common Name: Surgical Face Mask

Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX: Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Indication for use:

The 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.

Device Description:

The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user, which was provided in following table. The proposed device can be provided in sterile and non-sterile two types.

Model	Ear loop	Tie-on	Size (mm)
KWE-14.5×9 (Sterile)	√		145×90
KWE-17.5×9.5 (Sterile)	√		175×95
KWB-14.5×9 (Sterile)		√	145×90
KWB-17.5×9.5 (Sterile)		√	175×95
KWE-14.5×9 (Non-sterile)	√		145×90
KWE-17.5×9.5 (Non-sterile)	√		175×95
KWB-14.5×9 (Non-sterile)		√	145×90
KWB-17.5×9.5 (Non-sterile)		√	175×95

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1. Identification of Predicate Device
  510(k) Number: K173062 Product Name: NonWoven Face Mask

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity;
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization;
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
A ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
EN 14683: 2019 Medical face masks- Requirements and test methods
A ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
Clinical Test Conclusion 7.

No clinical study is included in this submission.

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8. Summary of Technological characteristics

ITEM	Proposed Device	Predicate Device	Remark
510(k) Number	K202843	K173062	/
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	The 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.	Non Woven Face Mask (Models:
VQN0185W (earloop) and
VQN0185B (ties)) 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.	Same
Mask style	Flat-pleated, 3 layers	Flat-pleated, 3 layers	Same
Design feature	Ear loop/Tie-on	Ear loop/Tie-on	Same
Color	Blue	Blue	Same
Dimension	1.
14.5cm×9cm:
Nose Clip: 85mm×2.9mm
Ear Loop: 180mm×3mm
Ties: 910mm×10mm

Table 1 Comparison of Surgical Face Masks

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Different- Dimension

The dimension for proposed device is different from predicate device. The proposed device provides more dimension options, which can allow users to choose the appropriate dimension of masks according to their needs. In addition, the different size does not affect the indication for use.

Different- Sterility

The proposed device can be provided in sterile. The proposed non-sterile mask is same as the predicate device, while the sterile mask is not covered by the predicate device. However, the sterilization process were validated per ISO 11135 and the result demonstrated that the sterilization process is effective. In addition, the performance test and biocompatibility test were also conducted on the sterilized mask and the test result demonstrated that the device can meet the requirements of level 2 mask and does not raise any adverse effects after sterilization.

Similar -Particulate filtration efficiency

The test result for particulate filtration efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Similar - Bacterial filtration efficiency

The test result for bacterial filtration efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Similar - Differential pressure

The test result for different pressure for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask.

Different- Patient Contacting Material

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The patient contacting material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect.

1. Conclusion
  The subject device is a safe, as effective, and perform as well as the legally marketed predicate device K173062 Non Woven Face Mask.