Disposable Medical Surgical Face Mask

• K Number: K203200
• Device Name: Disposable Medical Surgical Face Mask
• Manufacturer: Guangdong Haiou Medical Apparatus Co., Ltd.
• Date Cleared: 2021-06-16 ( 230 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

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.

Predicate Devices

K201137

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.

Therapeutic

No
The device is described as a protective nose and mouth covering to prevent exposure to microorganisms and body fluids, not for treating a disease or condition.

Diagnostic

No
The device is a protective face mask, as indicated by its stated intended use to "protect" against exposure to microorganisms 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-layered mask made of materials like polypropylene and polyethylene, with ear loops and a nose piece. It also details performance studies related to physical properties and biological responses, not software validation.

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 is to provide a physical barrier to protect healthcare workers and patients from exposure to microorganisms and body fluids during medical and surgical procedures. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological specimens.
• Device Description: The description details the physical construction of a mask designed for filtration and barrier protection. It does not mention any components or mechanisms for analyzing biological samples.
• Performance Studies and Key Metrics: The performance studies and key metrics (Fluid Resistance, Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility) are all related to the physical and protective properties of the mask, not to the accuracy or performance of a diagnostic test.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with IVD devices.

In summary, the Disposable Medical Surgical Face Mask is a personal protective equipment (PPE) device designed for physical barrier protection, not for diagnosing diseases or conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FXX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nose and mouth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare workers and patients

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 test conclusions were made based on the following tests:

• Fluid Resistance Performance (ASTM F1862) with a Level 3: 160 mm Hg acceptance criteria. Results: All samples met the predetermined acceptance criteria.
• Bacterial Filtration Efficiency (ASTM F2100-19) with a >= 98% acceptance criteria. Results: All samples met the predetermined acceptance criteria.
• Differential Pressure (Delta P) (ASTM F2100-19) with a 98% acceptance criteria. Results: All samples met the predetermined acceptance criteria.
• Flammability (21 CFR 1610) with a Class I, Does not Ignite acceptance criteria. Results: All samples met the predetermined acceptance criteria.
• Cytotoxicity (ISO 10993-5) with a Non-cytotoxic acceptance criteria. Results: All samples met the predetermined acceptance criteria.
• Irritation (ISO 10993-10) with a Non-irritating acceptance criteria. Results: All samples met the predetermined acceptance criteria.
• Sensitization (ISO 10993-10) with a Non-sensitizing acceptance criteria. Results: All samples met the predetermined acceptance criteria.

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

Not Found

Predicate Device(s)

K201137

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services on the left, and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue on the right. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.

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

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 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 ([e-mail]) or phone [phone] 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

2

Indications for Use

510(k) Number (if known) K203200

Device Name

Disposable Medical Surgical Face Mask

Indications for Use (Describe)

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.

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)

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

3

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:[phone]

• Fax: [phone]

• Contact Person(Title):Zhang Zhuo Xuan(General Manager) >
• ア E-mail: [e-mail]
• 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.

4

• 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: [phone]

• Fax: [phone]

• Contact Person(Title): Salon Chen (System engineer)

• E-mail: [e-mail]

6. 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.

7. Indications for Use Statement

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.

Comparison to the Predicate Device 8.

5

Elements of Comparison	Proposed Device	Predicate Device	Judgment
Company Name	Guangdong Haiou Medical
Apparatus Co., Ltd..	PFM Medical, Inc.	/
Device Name	Disposable Medical
Surgical 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 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.	The ASEPT® 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.	Same

6

| | | Inner and Outer
Layers | Spun-bond polypropylene | Spun-bond polypropylene | |
|-------------------------------------------------|------------------------------------|---------------------------|------------------------------------------------------------|------------------------------------------------------------|----------------|
| Materials | Middle Layer | | Melt blown polypropylene
filter | Melt blown polypropylene
filter | Same |
| | Ear Loops | | Polyester | Polyester | |
| | Nose Piece | | Malleable polyethylene
with aluminum wire | Malleable polyethylene
with aluminum wire | |
| | | | | | |
| Dimension | | | 17.5cm length x 9.5cm
height | 17.5cm length x 9.5cm
height | Same |
| Mask Style | | | Pleated | Pleated | Same |
| Design Features | | | Malleable nosepiece, flat
pleated,
elastic ear loops | Malleable nosepiece, flat
pleated,
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 | Different
1 |
| Resistance to Penetration by
Synthetic Blood | | | Level 3: 160 mm Hg | Level 2: 120 mm Hg | |
| Differential Pressure | | | Level 3: 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 and
skin sensitization | | |
| 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. |

8

9

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.