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 mask, with no mention of AI or ML.

Therapeutic

No
The device is a surgical mask intended to protect against the transfer of microorganisms and particulate materials, not to treat or diagnose a disease or condition.

Diagnostic

No

Explanation: The device description and intended use clearly state that this is a surgical mask designed to protect against the transfer of microorganisms, blood, and body fluids. There is no indication that it is used to diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components made of various materials (PP Spunbonded Non-woven Fabric, Melt-blown Nonwoven Fabric, Spandex, Polyester, Galvanized Iron Wire) and describes its function as a physical barrier, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the surgical mask is for protecting against the transfer of microorganisms, blood, body fluids, and particulate materials. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, test strips, or any components used to analyze biological samples.
Performance Studies and Key Metrics: The performance studies focus on the physical properties of the mask, such as filtration efficiency, fluid resistance, and flammability. These are relevant to its function as a barrier, not to diagnostic accuracy.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. A surgical mask does not perform any of these functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The surgical 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

FXX

Device Description

The proposed device, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. 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. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.

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

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 Fixed Volume at a Known Velocity)
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
EN 14683: 2019 Medical face masks- Requirements and test methods
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 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
ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals

Biocompatibility Testing:

Cytotoxicity (ISO 10993-5 and ISO 10993-10): The viability of tested samples (PRS-WK002 and PRS-WK017) was >= 70% of the blank. The 50% extract had a higher viability than the 100% extract. The device was non-cytotoxic.
Sensitization (ISO 10993-10): Tested samples (PRS-WK002 and PRS-WK017) showed no evidence of causing delayed dermal contact sensitization in guinea pigs. The device was non-sensitizing.
Irritation (ISO 10993-10): The irritation response category of tested samples (PRS-WK002 and PRS-WK017) was classified as Negligible for polar extract and Negligible for non-polar extract. The device was non-irritating.

Performance Testing:

Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M-2017): No penetration at 120mmHg for sterile (PRS-WK002) and non-sterile (PRS-WK017) ear loop non-edging models across multiple lots.
Particulate Filtration Efficiency (ASTM F2299/F2299M-03(2017)): >=98% acceptance criteria. Results for sterile (PRS-WK002) and non-sterile (PRS-WK017) ear loop non-edging models were all above 98%.
Bacterial Filtration Efficiency (ASTM F2101:2019): >=98% acceptance criteria. Average 99.64% for sterile and 99.60% for non-sterile samples. Specific lots of PRS-WK002 and PRS-WK017 showed results ranging from 99.53% to 99.74%.
Differential Pressure (EN 14683:2019+AC:2019 Annex C):

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

September 26, 2021

Sichuan Prius Biotechnology Co., Ltd. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 China

Re: K210908

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 9, 2021 Received: August 17, 2021

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.

1

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.

For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210908

Device Name

Surgical Mask (Model numbers identified in the attachment)

Indications for Use (Describe)

The surgical 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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Model	Size (cm)	Ear loop	Headband	Tie-on	Sterile	Non-sterile	Non-edging type	Edging type
PRS-WK001	17.5×9.5	√			√			√
PRS-WK002	17.5×9.5	√			√		√
PRS-WK003	17.5×9.5		√		√			√
PRS-WK004	17.5×9.5		√		√		√
PRS-WK005	17.5×9.5			√	√		NA
PRS-WK006	14.5×9.5	√			√			√
PRS-WK007	14.5×9.5	√			√		√
PRS-WK008	14.5×9.5		√		√			√
PRS-WK009	14.5×9.5		√		√		√
PRS-WK010	14.5×9.5			√	√		NA
PRS-WK016	17.5×9.5	√				√		√
PRS-WK017	17.5×9.5	√				√	√
PRS-WK018	17.5×9.5		√			√		√
PRS-WK019	17.5×9.5		√			√	√
PRS-WK020	17.5×9.5			√		√	NA
PRS-WK021	14.5×9.5	√				√		√
PRS-WK022	14.5×9.5	√				√	√
PRS-WK023	14.5×9.5		√			√		√
PRS-WK024	14.5×9.5		√			√	√
PRS-WK025	14.5×9.5			√		√	NA

4

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: K210908

1. Date of Preparation: 09/14/2021
1. Sponsor Identification

Sichuan Prius Biotechnology Co., Ltd.

No. 2, Prius Road, Luo Long Industrial Park Nanxi District, 644104 Yibin City, Sichuan Province, PEOPLE'S REPUBLIC OF CHINA.

Establishment Registration Number: Not registered yet.

Contact Person: Yan Liu Position: management representative Tel: +86-831-3839889 Fax: +86-831-3839887 Email: 48363603@qq.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: 360-925-3199 Email: info@mid-link.net

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Identification of Proposed Device 4.
Product Name: Surgical Mask Common Name: Surgical Masks

Regulatory Information Classification Number: 21 CFR 878.4040 Classification Name: Surgical apparel Product Code: FXX Regulatory Class: II Review Panel: General Hospital

1. Identification of Predicate Device
  510(k) Number: K202843 Product Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) Sponsor Name: B.J.ZH.F. Panther Medical Equipment Co., Ltd. Whether subject to a design-related recall: No

6. Device Description:

The proposed device, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. 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. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.

| Model | Sterile | Non-
sterile | Ear
loop | Tie-on | Headband | Size
(cm) | Non-edging
type | Edging
type | Color |
|-----------|---------|-----------------|-------------|--------|----------|--------------|--------------------|----------------|-------|
| | | | | | | | | | |
| PRS-WK002 | √ | | √ | | | 17.5×9.5 | √ | | Blue |
| PRS-WK003 | √ | | | | √ | 17.5×9.5 | | √ | Blue |
| PRS-WK004 | √ | | | | √ | 17.5×9.5 | √ | | Blue |
| PRS-WK005 | √ | | | √ | | 17.5×9.5 | NA | | Blue |

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PRS-WK006	√	√	14.5×9.5	√	Blue
PRS-WK007	√		14.5×9.5	√	Blue
PRS-WK008	√		14.5×9.5	√	Blue
PRS-WK009	√		14.5×9.5	√	Blue
PRS-WK010	√		14.5×9.5	NA	Blue
PRS-WK016		√	17.5×9.5	√	Blue
PRS-WK017		√	17.5×9.5	√	Blue
PRS-WK018		√	17.5×9.5	√	Blue
PRS-WK019		√	17.5×9.5	√	Blue
PRS-WK020		√	17.5×9.5	NA	Blue
PRS-WK021		√	14.5×9.5	√	Blue
PRS-WK022		√	14.5×9.5	√	Blue
PRS-WK023		√	14.5×9.5	√	Blue
PRS-WK024		√	14.5×9.5	√	Blue
PRS-WK025		√	14.5×9.5	NA	Blue

7. Indications for Use:

The surgical 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.

1. Summary of Technological characteristics

ITEM	Proposed Device	Predicate Device K202843	Remark
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 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.	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.	Same
Mask style	Flat-pleated, 3 layers	Flat-pleated, 3 layers	Same
Color	Blue	Blue	Same
Dimension
	17.5cm×9.5cm
14.5cm×9.5cm	17.5cm×9.5cm
14.5cm×9cm	Same
Level	Level 2	Level 2	Same
Sterility	Sterile/Non-Sterile	Sterile/Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
Fluid resistance	Sterile: Pass at 120mmHg
Non-sterile: Pass at 120mmHg	Pass at 120mmHg	Same
Particulate Filtration Efficiency	Sterile: Average 98.21%
Non-sterile: Average 98.20%	Average 98.98%	Different
Bacterial Filtration Efficiency	Sterile: Average 99.64%
Non-sterile: Average 99.60%	Average 98.92%	Different
Differential Pressure	Sterile: Average 3.02 mmH2O/cm²
Non-sterile: Average 2.87 mmH2O/cm²	Average 4.4 mmH2O/cm²	Different
Flammability	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Patient Contacting Material
Outer layer of mask	PP Spunbonded Non-woven Fabric	Spun-bonded nonwoven polypropylene
Middle layer of mask	Melt-blown Nonwoven Fabric	Melt-blown non-woven polypropylene
Inner layer of mask	PP Spunbonded Non-woven Fabric	Spun-bonded nonwoven polypropylene	Different
Nose Clip	Galvanized Iron Wire	Medical polypropylene and Q235
Ear Strap	PP Spunbonded Non-woven Fabric; Spandex and Polyester	Spun-bonded nonwoven polypropylene; Spandex and nylon
Biocompatibility
Cytotoxicity	ISO 10993-5 and ISO 10993-10;
Under the conditions of the study, the	ISO 10993-5 and ISO 10993-10;
Under the conditions of the study,
Sensitization	proposed device extract was determined to be non-cytotoxic,	the proposed device extract was determined to be non-cytotoxic,	same
Irritation	non-sensitizing, and non-irritating.	non-sensitizing, and non-irritating.
Test Method	Purpose	Acceptance Criteria	Results
Cytotoxicity	The test was performed in accordance with ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity to evaluate the cytotoxicity of the test sample.	The viability should be $\geq$ 70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract.	The viability of the tested samples included PRS-WK002 and PRS-WK017 was $\geq$ 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract.

Under the conditions of the study, the proposed device was non-cytotoxic. |
| Sensitization | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization to evaluate the sensitization of the test | Non-sensitizing | The tested samples included PRS-WK002 and PRS-WK017 showed no evidence of causing delayed dermal contact sensitization in the guinea pigs.

Under the conditions of the study, the proposed device was non-sensitizing. |

Table 1 Comparison of Surgical Mask

7

Differences in technological characteristics do not raise different questions of safety and effectiveness.

9. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications. The

8

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 Fixed Volume at a Known Velocity)
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
EN 14683: 2019 Medical face masks- Requirements and test methods
A 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 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
ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals

Table 2 Biocompatibility Testing

9

	sample.
Irritation	The test was performed in
accordance with ISO
10993-10 Third Edition
2010-08-01 Biological
evaluation of medical
devices - Part 10: Tests for
irritation and skin
sensitization to evaluate the
irritation of the test sample.	Non-irritating	The irritation response category of
the test samples included
PRS-WK002 and PRS-WK017 was
classified as Negligible for polar
extract and Negligible for non-polar
extract.

Under the conditions of the study,
the proposed device was
non-irritating. |

Table 3 Performance Testing
-----------------------------	--

Test Method	Purpose	Acceptance Criteria	Results
Resistance to
Penetration by
Synthetic
blood	The test was performed in
accordance with ASTM
F1862/F1862M:
2017
Standard Test Method for
Resistance of Medical Face
Masks to Penetration by
Synthetic Blood (Horizontal
Projection of Fixed Volume
at a Known Velocity) to
evaluate the effectiveness of
the test sample from possible
exposure to blood and other
body fluids.	No penetration at 120
mmHg	Sterile Ear loop Non-edging
(PRS-WK002):
Lot 200401: Pass at 120mmHg
Lot 200407: Pass at 120mmHg
Lot 200413: Pass at 120mmHg
Non-sterile Ear loop Non-edging
(PRS-WK017):
Lot 200401: Pass at 120mmHg
Lot 200405: Pass at 120mmHg
Lot 200407: Pass at 120mmHg
Particulate
Filtration
Efficiency	The test was performed in
accordance with 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 to
determine the particle
filtration efficiency (PFE) of
the test article.	≥98%	Sterile Ear loop Non-edging
(PRS-WK002):
Lot 200401: 98.19%
Lot 200407: 98.20%
Lot 200413: 98.24%
Non-sterile Ear loop Non-edging
(PRS-WK017):
Lot 200401: 98.22%
Lot 200405: 98.16%
Lot 200407: 98.22%
Bacterial	The test was performed in	≥98%	Sterile: Average 99.64%
Filtration Efficiency	accordance with 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 to determine the bacterial filtration efficiency (BFE) of the test article.		Non-sterile: Average 99.60%
Sterile Ear loop Non-edging (PRS-WK002):
Lot 210405: 99.74%
Lot 210407: 99.72%
Lot 210409: 99.70%

Non-sterile Ear loop Non-edging (PRS-WK017):
Lot 210405: 99.56%
Lot 210407: 99.54%
Lot 210409: 99.53% |
| Differential Pressure | The test was performed in accordance with EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods. |