"Skypro, SP02 Mask (Level 3)" is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended for infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.

Device Description

"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Skypro, SP02 Mask (Level 3)
Product Code: FXX
Regulation Name: Surgical apparel
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Biocompatibility Test:	To determine if the mask may cause adverse biological reactions.
Cytotoxicity Test (MEM Elution)	To determine if the mask may cause cytotoxic effects.	Non-cytotoxic	Non-cytotoxic
Sensitization Test (Kligman Max)	To determine if the mask may cause skin sensitization.	Non-sensitizing	Non-sensitizing
Primary Skin Irritation Test	To determine if the mask may cause skin irritation.	Non-irritating	Non-irritating
Fluid Resistance Test	To determine the capability of mask to resist the penetration of fluids.	Pass @ 160 mmHg	Pass
Particle Filtration Efficiency	To measure the filtration efficiency of mask for particulates.	≥ 98%	98.59%
Bacterial Filtration Efficiency	To measure the filtration efficiency of mask for bacteria.	≥ 98%	99.24%
Differential Pressure (Delta P)	To measure how easily air is passed, an indicator of air permeability or breathability.	< 6 mmH2O/cm²	4.04 mmH2O/cm²
Flammability Test	To determine if the mask ignites easily when exposed to or used near fire or heat.	Class 1	Class 1

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of masks tested for fluid resistance, number of animals for biocompatibility). It only states that "non-clinical tests" were performed.

The data provenance is not explicitly stated in terms of country of origin of the data or whether the studies were retrospective or prospective. However, given that these are performance tests for a medical device submitted to the FDA, they are generally conducted prospectively according to established laboratory standards (e.g., GLP for biocompatibility).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the document. The tests performed are objective, quantitative laboratory tests (e.g., measuring filtration efficiency, pressure, or observing biological reactions) against defined standards. Therefore, "experts to establish ground truth" in the way one might for diagnostic imaging or clinical interpretation is not relevant here. The ground truth is established by the specified test methods and their measurable outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the tests are objective laboratory measurements, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Test: No clinical testing was performed." These are non-clinical, laboratory performance tests of a surgical mask.

Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this device. The Skypro, SP02 Mask (Level 3) is a physical surgical mask, not an AI algorithm or a device with a software component that would involve standalone algorithm performance or human-in-the-loop performance.

7. The Type of Ground Truth Used

The ground truth for the performance tests is established by:

Defined ASTM/ISO/FDA recognized test standards and methodologies: These standards provide objective measurement protocols and criteria (e.g., for biocompatibility, filtration, flammability).
Quantitative measurements: For tests like Particle Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, the results are numerical values obtained from calibrated equipment.
Qualitative observations against predefined criteria: For biocompatibility, the outcomes are "non-cytotoxic," "non-sensitizing," and "non-irritating," which are determined by observing biological responses in accordance with test protocols.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product (surgical mask), not an AI/ML algorithm or a system that requires a "training set" in the context of machine learning.

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

This information is not applicable and not provided. As mentioned above, there is no training set for this type of device.

Summary

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December 24, 2021

Skypro Medical Supplies Company Cyrus Wong General Manager C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat Road, Tsing Yi, N.T. Hong Kong. China

Re: K202255

Trade/Device Name: Skypro, SP02 Mask (Level 3) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 9, 2021 Received: December 13, 2021

Dear Cyrus Wong:

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 Clarence W. Murray, III, PhD 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

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Indications for Use

510(k) Number (if known) K202255

Device Name Skypro, SP02 Mask (Level 3)

Indications for Use (Describe)

Description	Item No.	Color	Size
Earloop mask	L3RELX	Blue	175 mm x 95 mm
Earloop mask	L3MELX	Blue	145 mm x 95 mm
Tie-on mask	L3RTOX	Blue	175 mm x 95 mm

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)

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510(k) Summary K202255

Skypro Medical Supplies Company

Date of Submission: 9th December, 2021 Date of Preparation: 9th December, 2021

1. Manufacturer

Company: SPRO Medical Products (Xiamen) Co., Ltd Address: No.139 Factory Building, TongAn Garden, TongAn Industrial Area, Xiamen, Fujian Province, 361100, P. R. China

2. Official Correspondent and Applicant

Contact Person: Cyrus Wong (General Manager) Company: Skypro Medical Supplies Company Address: Flat C301, 3/F, Block C, Phase 2, Tsing Yi Industrial Centre, 1-33 Cheung Tat Road, Tsing Yi, New Territories, Hong Kong, P. R. China Phone No.: 852-27110882 Fax No.: 852-27110116 Email: cyrus@skypro-med.com

3. US Agent and Correspondent

Company: SKYPRO MEDICAL SUPPLIES USA LTD COMPANY Address: 5722 Kendall Hill Ln, Sugar Land, TX 77479 Contact Person: Eve Luo Email: Eve@1masks.com Phone No.: 832-312-2668 EIN/TAX ID: 851587593

4. Details of Device

Device Trade Name: Skypro, SP02 Mask (Level 3) Classification Name: Mask, Surgical (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FXX Device Common Name/ Classification Name: Surgical Mask Predicate Device: Skypro, SP01 Mask (K152197)

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Labels/ Labeling:

"Skypro, SP02 Mask (Level 3)" is marketed as a single-use and disposable surgical or procedure mask. It is a prescription device.

Intended Use:

Device Description:

"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.

No.	Item No.	Description
1	L3RELX	The face mask (size: 175 mm x 95 mm) is composed of four-layer non-wovenpolypropylene fabrics, a moldable nose clip, and earloops. The earloops are attachedto the corners of mask blank. Seam sealing is applied to the edge of mask blank.
2	L3RTOX	The face mask (size: 175 mm x 95 mm) is composed of four-layer non-wovenpolypropylene fabrics, a moldable nose clip, and ties. Seam sealing is applied tothe edge of mask blank.
3	L3MELX	The face mask (size: 145 mm x 95 mm) is composed of four-layer non-wovenpolypropylene fabrics, a moldable nose clip, and earloops. The earloops are attachedto the corners of mask blank. Seam sealing is applied to the edge of maskblank.

Note: The details of each item have been indicated in the relevant "Product Drawing" files.

Technological Characteristic Comparison with Predicated Device:

Description	Predicate K152197"Skypro, SP01Mask"	Subject Device K202255"Skypro, SP02 Mask (Level 3)"	Comparison
Materials
Outer Layer	Spunbond polypropylene	Spunbond polypropylene	Similar
Middle Layer	Meltblown polypropylene	1st Spunbond polypropylene2nd Meltblown polypropylene	Similar
Inner layer	Spunbond polypropylene	Spunbond polypropylene	Similar
Nose Piece	Metal wire(s) coatedwith polyethylene	Metal wire(s) coated withpolyethylene	Similar
Ear Attachment	Elastic latex-freeearloops or ties	Elastic latex-free earloops orties	Similar
Specificationand PhysicalSizes	Earloop mask:175 mm x 95mm;145 mm x 95mm; Tie-onmask:175 mm x 95 mm	Earloop mask: 175mm x 95 mm;145 mm x 95 mm;Tie-on mask:175 mm x 95 mm	Similar
Mask Style	Flat-pleated	Flat-pleated	Similar

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Design Features	3 layers of non-woven fabrics with adense fiber	4 layers of non-woven fabrics witha dense fiber web as one	Similar
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	web as the middle layer	of the middle layers	Similar	Test Methodology	Purpose	AcceptanceCriteria	Result
Color	White	Blue	Different	1. Biocompatibility Test
Indications for Use	"Skypro, SP01 Mask" isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. It isintended for infection controlpractices to reduce the potentialexposure of the wearer to bloodand body fluids. It is a non-sterile, single-use, and disposable device.	"Skypro, SP02 Mask (Level 3)" isintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, body fluids,and particulate material. It is intendedfor infection control practices to reducethe potential exposure of the wearer toblood and body fluids. It is a non-sterile, single-use, and disposable device.	Similar	- Cytotoxicity Test: MEM ElutionGLP Report;	To determine if the mask may causecytotoxic effects	Non-cytotoxic	Non-cytotoxic
Performance Characteristics				- Sensitization Test: KligmanMaximization Test - ISO (GLP)	To determine if the mask may causeskin sensitization	Non-sensitizing	Non-sensitizing
Fluid ResistancePerformance(mmHg)	Pass @ 120 mmHg	Pass @ 160 mmHg	Different	- Primary Skin Irritation Test:Intracutaneous Injection Test -ISO (GLP)	To determine if the mask may causeskin irritation	Non-irritating	Non-irritating
Particulate FiltrationEfficiencyPerformance	99.28%	98.59%	Similar	2. Fluid Resistance Test	To determine the capability of maskto resist the penetration of fluids	Pass @160 mmHg	Pass
Bacterial FiltrationEfficiency Performance	99.66%	99.24%	Similar	3. Particle Filtration Efficiency Test	To measure the filtration efficiency ofmask for particulates	≥ 98%	98.59%
DifferentialPressure (Delta P)	3.72 mmH2O/cm²	4.04 mmH2O/cm²	Similar	4. Bacterial Filtration Efficiency(BFE) Test	To measure the filtration efficiency ofmask for bacteria	≥ 98%	99.24%
Flammability Class	Class 1	Class 1	Same	5. Differential Pressure (Delta P)Test	To measure how easily air is passedfrom one side of the mask to theother, which can function asanindicator of air permeabilityorbreathability	< 6 mmH2O	4.04 mmH2O/cm²
Biocompatibility Test				6. Flammability Test	To determine if the mask igniteseasily when exposed to or used nearfire or heat	Class 1	Class 1
Cytotoxicity	Under the conditions ofthe study the sample wasfound to be non-cytotoxic	Under the conditions of thestudy the sample was found tobe non-cytotoxic	Same
Sensitization	Under the conditions ofthestudy the sample wasfound to be non-sensitizing	Under the conditions of thestudy the sample was found tobe non-sensitizing	Same
Primary Skin Irritation	Under the conditions ofthe study the sample wasfound to be non-irritating	Under the conditions of thestudy the sample was found tobe non-irritating	Same
Sterilization	Non-sterile: single-use	Non-sterile: single-use	Same

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Summary of Non-Clinical Testing:

Clinical Performance Test: No clinical testing was performed.

5. Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(K) submission K202255, the "Skypro, SP02 Mask (Level 3)" is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K152197.

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.