Disposable Medical Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Device Description

Disposable Medical Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device.

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the performance of a Disposable Medical Surgical Face Mask.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Item	Standard	Acceptance Criteria	Reported Device Performance
Fluid Resistance Performance	ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood	Level 3: 160 mm Hg	All samples met the predetermined acceptance criteria.
Bacterial Filtration Efficiency (BFE)	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	≥ 98%	All samples met the predetermined acceptance criteria.
Differential Pressure (Delta P)	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	< 6.0 mm H2O/cm2	All samples met the predetermined acceptance criteria.
Particulate Filtration Efficiency	ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks	≥ 98% (referred to as Sub-Micron Particulate Filtration in comparison table)	All samples met the predetermined acceptance criteria.
Flammability	21 CFR 1610	Class I, Does not Ignite	All samples met the predetermined acceptance criteria.
Cytotoxicity	ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity	Non-cytotoxic	All samples met the predetermined acceptance criteria.
Irritation	ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization	Non-irritating	All samples met the predetermined acceptance criteria.
Sensitization	ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization	Non-sensitizing	All samples met the predetermined acceptance criteria.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific numerical sample size used for each test. Instead, it generically states "All samples met the predetermined acceptance criteria." for the results.

Regarding data provenance:

The tests were conducted as non-clinical data as per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions.
The manufacturer is Guangdong Haiou Medical Apparatus Co., Ltd. located in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The testing described is for a medical face mask, and involves objective performance criteria (e.g., filtration efficiency, fluid resistance) measured against established industry standards (ASTM, ISO, CFR). It does not involve human expert interpretation of images or other data to establish a "ground truth" in the way an AI diagnostic device would.

4. Adjudication method for the test set

This information is not applicable and not provided in the document for the reasons stated in point 3.

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 information is not applicable and not provided in the document. This is not a study involving human readers or AI assistance. It's a performance test for a physical medical device.

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

This information is not applicable and not provided in the document. The device is a physical face mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of the Disposable Medical Surgical Face Mask is established by objective measurements against recognized industry standards and regulatory requirements. These include:

ASTM F1862 (Fluid Resistance)
ASTM F2100-19 (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency)
21 CFR 1610 (Flammability)
ISO 10993-5 (Cytotoxicity)
ISO 10993-10 (Irritation and Sensitization)

8. The sample size for the training set

This information is not applicable and not provided in the document. There is no "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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June 16, 2021

Guangdong Haiou Medical Apparatus Co., Ltd. % Salon Chen System Engineer IMD Medical & Drug technology service institutions Tianbao office room 225,Sha Tai Road No.209 ShenZhen city, Guangdong Province 518117 China

Re: K203200

Trade/Device Name: Disposable Medical Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 13, 2021 Received: May 13, 2021

Dear Salon Chen:

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,

Clarence W. Murray, III, Ph.D. Acting 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) K203200

Device Name

Disposable Medical 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

1. Submitter's Information

Company Name: Guangdong Haiou Medical Apparatus Co., Ltd.
Establishment Registration Number: 3010596027
Address:Nanyuan Industrial Zone, North Liusha, Puning City, Guangdong, China
Phone:+86-663-2758666
Fax: +86-663-2905999
Contact Person(Title):Zhang Zhuo Xuan(General Manager) >
ア E-mail: hoyl@haiou.net.cn
Device Information 2.
Trade Name: Disposable Medical Surgical Face Mask
Common Name: Mask,Surgical
Classification Name: Surgical Apparel
Model: HO-KZ01
510(k) Number: K203200
Classification 3.
Classification Product Code: FXX
Regulation Number: 21 CFR 878.4040
Classification: Class II
Review Panel: General Hospital
Predicate Device Information: 4.

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510(k) Number: K201137 >
Predicate Device Name: ASEPT® Surgical Face Mask
Manufacturer: PFM Medical, Inc.
This predicate has not been subject to a design-related recall
No reference devices were used in this submission.

5. Application Correspondent

Company Name: IMD Medical & Drug technology service institutions
Phone: +86-18613190779
Fax: +86-755-62809168
Contact Person(Title): Salon Chen (System engineer)
E-mail: 33999439@qq.com

6. Device Description

7. Indications for Use Statement

Comparison to the Predicate Device 8.

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Elements of Comparison	Proposed Device	Predicate Device	Judgment
Company Name	Guangdong Haiou MedicalApparatus Co., Ltd..	PFM Medical, Inc.	/
Device Name	Disposable MedicalSurgical Face Mask	ASEPT® Surgical Face Mask	/
510(k) Number	K203200	K201137	/
Classification Product Code	FXX	FXX	Same
Regulation	21 CFR 878.4040	21 CFR 878.4040	Same
Classification Name	Surgical Apparel	Surgical Apparel	Same
Class	2	2	Same
Prescription or OTC	OTC	OTC	Same
Intended Use & Indications for Use	Disposable MedicalSurgical Face Mask isindicated as a protectivenose and mouth coveringfor healthcare workers andpatients involved inmedical and surgicalprocedures. The masksare indicated in anyprocedure or situationwhere there is a risk ofexposure tomicroorganisms and bodyfluids.	The ASEPT® SurgicalFace Mask is indicated asa protective nose andmouth covering forhealthcare workers andpatients involved inmedical and surgicalprocedures. The masksare indicated in anyprocedure or situationwhere there is a risk ofexposure tomicroorganisms and bodyfluids.	Same

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		Inner and OuterLayers	Spun-bond polypropylene	Spun-bond polypropylene
Materials	Middle Layer		Melt blown polypropylenefilter	Melt blown polypropylenefilter	Same
	Ear Loops		Polyester	Polyester
	Nose Piece		Malleable polyethylenewith aluminum wire	Malleable polyethylenewith aluminum wire

Dimension			17.5cm length x 9.5cmheight	17.5cm length x 9.5cmheight	Same
Mask Style			Pleated	Pleated	Same
Design Features			Malleable nosepiece, flatpleated,elastic ear loops	Malleable nosepiece, flatpleated,elastic ear loops	Same
Sterility			Non-sterile	Non-sterile	Same
Use			Single Use,Disposable	Single Use,Disposable	Same
Color			Blue and White	Blue and White	Same
ASTM F2100 level			Level 3	Level 2	Different1
Resistance to Penetration bySynthetic Blood			Level 3: 160 mm Hg	Level 2: 120 mm Hg
Differential Pressure			Level 3: < 6.0	Level 2: <6.0	Same
Flammability			Class 1	Class 1	Same
Bacterial Filtration Efficiency(BFE)			Level 3: ≥ 98	Level 2: ≥ 98	Same
Sub-Micron Particulate Filtration			Level 3: ≥ 98	Level 2: ≥ 98	Same
Biocompatibility	Cytotoxicity,ISO10993-5:2009	Non-cytotoxic	Non-cytotoxic	Same
	Irritation,ISO10993-10:2002	Non-irritating	Non-irritating
	Sensitization,ISO10993010:2002	Non-sensitizing	Non-sensitizing

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Analysis:

Different 1:According to ASTM F2100 standard and test result, Haiou's Disposable Medical Surgical Face Mask ratings is level 3, the level 3 performance is the better than the level 2 performance in ASTM F2100 standard,thus,Haiou's Disposable Medical Surgical Face Mask is safe.

9. Non-Clinical Test Conclusion

Non-clinical data:

Per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions, the below testing has been completed on the subject device:

Item	Standard	Acceptance Criteria	Results
Fluid ResistancePerformance	ASTM F1862:Standard Test Methodfor Resistance ofMedical Face Masks toPenetration bySynthetic Blood	Level 3:160 mm Hg	All samples met thepredeterminedacceptance criteria.
Bacterial FiltrationEfficiency	ASTM F2100-19:Standard Specificationfor Performance ofMaterials Used inMedical Face Masks	$\ge$ 98%	All samples met thepredeterminedacceptance criteria.
Differential Pressure	ASTM F2100-19:	< 6.0 mm H2 O/cm2	All samples met the

(Delta P)	Standard Specification		predetermined
	for Performance of		acceptance criteria.
	Materials Used in
	Medical Face Masks
	ASTM F2100-19:		All samples met the
Particulate Filtration	Standard Specification	> 98%	predetermined
Efficiency	for Performance of		acceptance criteria.
	Materials Used in
	Medical Face Masks
			All samples met the
Flammability	21 CFR 1610	Class I, Does not Ignite	predetermined
			acceptance criteria.


	ISO 10993-5:
	Biological evaluation		All samples met the
Cytotoxicity	of medical devices	Non-cytotoxic	predetermined
	— Part 5: Tests		acceptance criteria.
	for in vitro
	cytotoxicity

	ISO 10993-10:		All samples met the
Irritation	Biological	Non-irritating
	evaluation of medical		predetermined
			acceptance criteria.
	devices —
	Part 10: Tests for
	irritation andskin sensitization
Sensitization	ISO 10993-10:Biologicalevaluation of medical devices —Part 10: Tests forirritation andskin sensitization	Non-sensitizing	All samples met thepredeterminedacceptance criteria.

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10. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) Disposable Medical Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201137.

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.