Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) 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 proposed Surgical Mask (Procedure Mask) body is a multi-layer construction of a Spun- bond polypropylene outer layer, meltblown middle layer and Spun-bond polypropylene inner layer. Nose clip is made of Aluminum plastic wire. There are two models of the proposed Surgical Mask (Procedure Mask), OH02-01 and OH02-01(Bandage). The main difference between each model is their wearing method, i.e. mask band part. For OH02-01 model, mask band part is made of non-woven fabric ear loops. For OH02-01(Bandage) model, mask band part is made of non-woven fabric ties. However, the raw materials of the two models devices are exactly the same. And have been tested according to ASTM F2100-19 Standard Specification For Performance Of Materials Used In Medical Face Masks. Surgical Mask (Procedure Mask) is a single use, disposable medical device that will be provided in non-sterile packaging configurations.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a Surgical Mask (Procedure Mask). It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

Crucially, this document is for a physical medical device (a surgical mask), not an AI/software medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets acceptance criteria" in the context of an AI/software medical device (e.g., using a test set, ground truth established by experts, MRMC studies) do not apply here.

Instead, the "acceptance criteria" for a surgical mask relate to its physical performance characteristics and biocompatibility, as defined by recognized standards (e.g., ASTM F2100-19, ISO 10993). The "study" proving the device meets these criteria involves laboratory testing of physical samples.

Here's the information extracted from the document, re-interpreting the "acceptance criteria" for a physical medical device:

1. Acceptance Criteria and Reported Device Performance

The device is a surgical mask, and its performance is evaluated against the ASTM F2100-19 standard for materials used in medical face masks, which defines levels of protection based on specific physical tests. The reported device performance is based on fulfilling the requirements for "Level 3".

Item (Performance Requirement)	Acceptance Criteria (ASTM F2100-19 Level 3)	Reported Device Performance
Fluid Resistance (ASTM F1862)	Fluid resistant claimed at 160 mm Hg	32 out of 32 Pass at 160 mmHg (Average of 3 lots with 32 samples per lot)
Particulate Filtration Efficiency (PFE) (ASTM F2299)	≥ 98% (for 0.1 µm polystyrene latex spheres)	Pass at 99.12% (Average of 3 lots with 32 samples per lot)
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	≥ 98%	Pass at 99.79% (Average of 3 lots with 32 samples per lot)
Differential Pressure (Delta P) (MILM-36954C)	< 6.0 mm H2O/cm²	3.57 mmH2O/cm² (Average of 3 lots with 32 samples per lot)
Flammability (16 CFR 1610)	Class 1	Class 1 (Average of 3 lots with 32 samples per lot)
Cytotoxicity (ISO 10993-5:2009)	Non-Cytotoxic	Non-Cytotoxic
Irritation (ISO 10993-10:2010)	Non-Irritating	Non-Irritating
Sensitization (ISO 10993-10:2010)	Non-Sensitizing	Non-Sensitizing

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

For the performance tests:

Sample Size: "Average of 3 lots with 32 samples per lot" was used for each performance test (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability). This refers to physical samples of the surgical masks.
Data Provenance: The document implies these tests were conducted by the manufacturer, Ningbo Ouhan Medical Device Co., Ltd., which is based in Zhejiang, China. The document does not specify if the testing was retrospective or prospective in nature regarding data collection, but it is typically prospective testing of manufactured batches.

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

This concept is not applicable to this type of medical device (surgical mask). "Ground truth" in this context is established by the standardized test methods themselves and the quantitative results obtained from laboratory equipment, not by human expert consensus or clinical interpretation.

4. Adjudication Method for the Test Set

This concept is not applicable. Test results for physical properties are objective measurements.

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 concept is not applicable. This is a physical medical device, not an AI or software device that would assist human readers in interpretation.

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

This concept is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of the surgical mask is defined by the quantitative results from standardized physical and biological laboratory tests, performed according to the specified ASTM and ISO standards. This is an objective, empirical ground truth based on measurable physical and chemical properties, rather than expert consensus, pathology reports, or outcomes data typically associated with AI/software medical devices.

8. The Sample Size for the Training Set

This concept is not applicable. This is a physical medical device. There is no "training set" in the context of an AI algorithm. The manufacturing process of a surgical mask is optimized through quality control and adherence to specifications, not machine learning training.

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

This concept is not applicable. As there is no training set for an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 17, 2021

Ningbo Ouhan Medical Device Co., Ltd. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College BLVD, STE 475 Santa Clara, California 95054

Re: K203418

Trade/Device Name: Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 19, 2021 Received: August 25, 2021

Dear Rafi 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

{1}------------------------------------------------

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,

Liqun Zhao -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203418

Device Name

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510K SUMMARY of K203418

Date of Summary Prepared: September 16, 2021 510K Number: K203418

1. Submitter Information

Submitter Contact: Ningbo Ouhan Medical Device Co., Ltd. Address: No.16, West Ruhu Road, Simen Town, Yuyao City, Zhejiang, China, 315470 Fax number: +86 (574)-62137995

Submitter Contact Person: Name: Annie Phone Number: +86 (574)-62137999 Email: annie@ouhanmedical.com

Designated Submission Correspondent: Name: Rafi Wong Phone Number: +1 (408) 646-6537 Email: rafi.wong@pfmfinance.com

2. Device Name:

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

3. Regulatory Information

Classification Name: Mask, Surgical Common Name: Surgical Apparel Apparel Classification: Class II Product Code: FXX Regulation Number: 21 CFR 878.4040

4. Predicate Device

{4}------------------------------------------------

510K Number: K200923 - BYD Precision Manufacturer Co.Ltd. Device Name: Single-use Surgical Mask Cleared date: August 26, 2020

5. Intended Use/Indications for use

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

6. Device Description

7. Summary of Comparison and Technological Characteristics

Items	Proposed Device	Predicate Device	Comparison
Product Common Name	Surgical Mask(Procedure Mask)	Single-use SurgicalMask	Difference
Manufacturer	Ningbo OuhanMedical DeviceCo.,Ltd.	BYD PrecisionManufacturerCo.Ltd.	-

Table I - General Comparison

{5}------------------------------------------------

510K Number	K203418	K200923	-
Product Code	FXX	FXX	Same
Classification	Class II (21 CFR 878.4040)	Class II (21 CFR 878.4040)	Same
Intended Use/Indications for Use	Surgical Mask(Procedure Mask)(Models: OH02-01,OH02-01 (Bandage))are intended to beworn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms,body fluids andparticulate material.These face masks areintended for use ininfection controlpractices to reducethe potential exposureto blood and bodyfluids.This is a single use,disposable device(s),provided non-sterile.	The Single-use SurgicalMasks(Model:FE2311)are intended to beworn to protect boththe patient andhealthcarepersonnel fromtransfer ofmicroorganisms,body fluids andparticulate material.These face masksare intended for usein infection controlpractices to reducethe potentialexposure to bloodand body fluids.This is a single use,disposable device(s),provided non-sterile.	Same
Model	Flatearhooktype, 3layers	Ear loop, FlatPleated, 3 layers	Similar
Materials	Outer Layer	Spun-bondpolypropylene	Spun-bondpolypropylene	Same
	Middle Layer	Meltblownpolypropylene filter	Melt blownpolypropylene filter	Same
	Inner Layer	Spun-bondpolypropylene	Spun-bondpolypropylene	Same
	Nose Piece	Aluminum plasticwire	Metal Core Plastic	Similar
	Ear Loops/Ties	Non-woven fabric	Polyester	Difference
Color	Blue And White	Blue	Similar
Dimension (Width)	17.5 cm +/- 0.5 cm	17.5 cm +/- 0.4 cm	Similar
Dimension (Length)	9.5 cm +/- 0.5 cm	9.5 cm +/- 0.4 cm	Similar
OTC Use	Yes	Yes	Same
Single Use		Yes	Yes	Same
Sterile		No	No	Same
Sterilization modality		-	-	Same
ASTM F2100-19 Level		Level 3	Level 3	Same
PerformanceTesting	FluidResistancePerformanceASTM F1862	32 out of 32 Pass at160 mmHg	32 out of 32 Pass at160 mmHg	Same
	ParticulateFiltrationEfficiencyASTM F2299	Pass at 99.12%	Pass at 99.67%	Similar
	BacterialFiltrationEfficiencyASTM F2101	Pass at 99.79%	Pass at 99.95%	Similar
	DifferentialPressure (DeltaP) MILM-36954C	3.57 mmH2O/cm²	5.62 mmH2O/cm²	Similar
	Flammability16 CFR 1610	Class 1(16 CFR 1610)	Class 1(16 CFR 1610)	Same
BiocompatibilityTesting (ISO10993-1)	CytotoxicityISO 10993-5:2009	Non-Cytotoxic	Non-Cytotoxic	Same
	IrritationISO 10993-10:2010	Non-Sensitizing	Non-Sensitizing	Same
	SensitizationISO 10993-10:2010	Non-Irritating	Non-Irritating	Same

{6}------------------------------------------------

*The difference in the materials and colors does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.

8. Non-clinical Tests Performed on the Proposed Device

The proposed device was 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.

STANDARDS:

{7}------------------------------------------------

ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face ● Masks.
ASTM F1862-13, Standard Test Method For Resistance Of Medical Face Masks To Penetration ● By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity).
. ASTM F2299-03, Standard Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
16 CFR 1610, Standard For The Flammability Of Clothing Textiles. .
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro . Cytotoxicity.
10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And ● Skin Sensitization.

Item	Purpose	Acceptance Criteria	Result
Fluid ResistancePerformanceASTM F1862	In order to verifywhether the subjectdevice meets theperformancerequirements of ASTMF2100 level 3,Resistance to penetrationby synthetic blood,minimum pressure inmm Hg for pass result:Fluid resistant claimed at160 mm Hg	Fluid resistant claimedat 160 mm Hg	32 out of 32 Pass at160 mmHg (Averageof 3 lots with 32samples per lot)Pass
Particulate FiltrationEfficiencyASTM F2299	In order to verifywhether the subjectdevice meets theperformance	≥ 98%	Pass at 99.12%(Average of 3 lotswith 32 samples perlot)

	requirements of ASTMF2100 level 3, Sub-micron particulatefiltration efficiency at 0.1um of Polystyrene LatexSpheres: ≥ 98%		Pass
Bacterial FiltrationEfficiencyASTM F2101	In order to verifywhether the subjectdevice meets theperformancerequirements of ASTMF2100 level 3, Bacterialfiltration efficiency: ≥98%	≥ 98%	Pass at 99.79%(Average of 3 lotswith 32 samples perlot)Pass
Differential Pressure(Delta P) MILM-36954C	In order to verifywhether the subjectequipment meets theperformancerequirements of ASTMF2100 level 3,Differential pressure(Delta-P): <6.0 mmH2O/cm²	<6.0 mm H2O/cm²	3.57 mmH2O/cm²(Average of 3 lotswith 32 samples perlot)Pass
Flammability16 CFR 1610	In order to verifywhether the subjectequipment meets theperformancerequirements of ASTMF2100 level 3, Flamespread: Class 1	Class 1	Class 1 (Average of 3lots with 32 samplesper lot)(16 CFR 1610)Pass
Item	Purpose	Acceptance Criteria	Result
CytotoxicityISO 10993-5:2009	Under the researchconditions, determinewhether the target deviceextract is cytotoxic.	Under the conditions ofthe study, the subjectdevice extract wasdetermined to be non-cytotoxic.	Non-Cytotoxic
Irritation ISO10993-10: 2010	Under the researchconditions, determinewhether the non-polarand polar extracts of thetarget device aresensitive.	Under the conditions ofthe study, the subjectdevice non-polar and polarextracts were determinedto be non-sensitizing.	Non- Sensitizing
SensitizationISO 10993-10: 2010	Under the researchconditions, determinewhether the non-polarand polar extracts of thetarget device areirritating.	Under the conditions ofthe study, the subjectdevice non-polar and polarextracts were determinedto be non-irritating.	Non-Irritating

Table II - Performance Testing Comparison Table

{8}------------------------------------------------

{9}------------------------------------------------

Table III - Biocompatibility Testing Comparison Table

9. Clinical Test

There is no clinical study included in this submission.

10. Conclusion

The conclusions drawn from the non-clinical tests (biocompatibility and physical performance testing) demonstrate that the proposed device Surgical Mask (Procedure Mask) is as safe, as effective, and performs as well as or better than the predicate device, the Single- use Surgical Mask (K200923) manufactured by BYD Precision Manufacturer Co.Ltd.

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.