K Number
K202580
Device Name
Disposable Surgical Mask
Date Cleared
2021-06-07

(272 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
Device Description
The Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.
More Information

Not Found

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.

No
The device, a Disposable Surgical Mask, is intended for protection against the transfer of microorganisms, body fluids, and particulate material, and for infection control; it does not treat or cure any condition, which is the definition of a therapeutic device.

No
The device, a Disposable Surgical Mask, is intended to protect against transfer of microorganisms and body fluids, not to diagnose a condition or disease. Its performance studies focus on filtration efficiency, fluid resistance, and biocompatibility, which are protective rather than diagnostic metrics.

No

The device description clearly outlines a physical, disposable surgical mask made of various polypropylene layers and ear loops. The performance studies focus on physical properties and material safety, not software functionality.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. 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 of the mask (layers, materials, ear loops, nose piece). There is no mention of reagents, assays, or any components used for analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in the body
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The testing performed (filtration efficiency, resistance to penetration, etc.) are performance tests for a physical barrier, not diagnostic tests.

N/A

Intended Use / Indications for Use

The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.

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

patient and healthcare personnel

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)

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.
Performance tests:

  • Resistance to penetration by synthetic blood ASTM F1862: 32 out of 32 passed in 160 mm Hg. Acceptance Criteria: 29 out of 32 passed in 160 mm Hg. Result: Pass.
  • Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2299: >=99%. Acceptance Criteria: >=98%. Result: Pass.
  • Bacterial filtration efficiency ASTM F2101-19: >=99%. Acceptance Criteria: >=98%. Result: Pass.
  • Differential pressure MIL-M-36954: Average 3.7 mmH2O/cm². Acceptance Criteria:

§ 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.

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June 7, 2021

Qingdao Likangyuan Medical Device Co., Ltd. % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302. Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 325000 China

Re: K202580

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 16, 2021 Received: May 6, 2021

Dear Helen Nan:

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 and Part 809): medical device reporting (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-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,

Bifeng Qian -S

For 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 Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K202580

Device Name Disposable Surgical Mask

Indications for Use (Describe)

The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

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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3

510(k) Summary for K202580

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1.0 Submitter Information

Company:Qingdao Likangyuan Medical Device Co.,
Ltd.
Address:No.257 Leigongshan Road,Huangdao
District,Qingdao,Shandong, 266423, China
Phone:086-532-89052813
Contact Name:Ying Xu
Title:Quality Control Manager
E-mail:likangyuan@hotmail.com
Date of Preparation:June 4, 2021

2.0 Submission Correspondent:

Company:Wenzhou Cytech Information Service Co., Ltd.
Mailing Address:Room302, Building3, Hangqian Mansion,
Hangqian Street, Lucheng District, Wenzhou,
Zhejiang, 325000, CHINA
Contact Name:Helen Nan
Title:General Manager
Email:ctc_registration@hotmail.com

3.0 Subject Device Information

Trade/Device Name:Disposable Surgical Mask
Model:Ear-loop Type
Common Name:Surgical Face Mask
Regulation Description:Surgical apparel
Device:Mask, Surgical
Review Panel:General Hospital
Product Code:FXX
Regulation Number:21 CFR 878.4040
Device Class:Class II

4.0 Predicate Device Information

Submitter:DemeTECH Corporation
510k Number:K201479
Trade/Device Name:DemeMASK
Common Name:Surgical Face Mask
Regulation Description:Surgical apparel
Device:Mask, Surgical
Review Panel:General Hospital

4

Product Code:FXX
Regulation Number:21 CFR 878.4040
Device Class:Class II

5.0 Device Description

The Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.

6.0 Indications for Use

The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

DevicePredicate DeviceProposed DeviceComparison
ManufacturerDemeTECH CorporationQingdao Likangyuan
Medical Device Co., Ltd.N/A
510K NumberK201479K202580N/A
Trade/Device
NameDemeMASKDisposable Surgical
Mask (non-sterile)N/A
Product CodeFXXFXXSame
ClassificationClass II
(21 CFR 878.4040)Class II
(21 CFR 878.4040)Same
Intended UseThe Disposable Surgical
Face Mask is intended to
be worn to protect both
the patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate
material.
This face mask is
intended for use in
infection control practicesThe Disposable Surgical
Masks (non-sterile) 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 inSame

7.0 Comparison of Technological Characteristics

Table 1 - General Comparison

5

| | to reduce the potential
exposure to blood and
body fluids. This is a
single use, disposable
device provided non-
sterile. | infection control
practices to reduce the
potential exposure to
blood and body fluids.
This is a single use,
disposable device
provided non-sterile. | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | Material | | |
| Outer Facing
Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| | Melt Blown | Melt Blown | |
| Middle Layer | Polypropylene
Filter | Polypropylene
Filter | Same |
| Inner Facing
Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanize Wire,
Coated By PE | Single Galvanize Wire,
Coated By PE | Same |
| Mask Style | 3 Ply, Ear Loops, Flat-
Pleated Style | 3 Ply, Ear Loops, Flat-
Pleated Style | Same |
| Ear loops | Spandex and Nylon | Spandex and Nylon | Same |
| Color | White | Blue (Outer layer)
White (Inner layer) | Similar |
| Dimension
(Width) | $9.5 cm \pm 1 cm$ | $9.5 cm$ | Similar |
| Dimension
(Length) | $17.5 cm \pm 1 cm$ | $17.5 cm$ | Similar |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Shelf life | No Shelf Life | 2 yrs | Different |
| Use | Single Use | Single Use | Same |
| ASTM F2100
Level | Level 3 | Level 3 | Same |

Table 2 - Performance Testing
-----------------------------------

| Device | Predicate Device
DemeMASK | Proposed Device
Disposable Surgical
Mask | Comparison |

--------------------------------------------------------------------------------------------------

6

| Fluid Resistance
Performance
ASTM F1862 | Pass at 160 mmHg
(Level 3 Fluid
Resistance) | Pass at 160 mmHg
(Level 3 Fluid
Resistance) | Same |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------|
| Particulate
Filtration
Efficiency
ASTM F2299 | Pass at ≥99% | Pass at ≥99% | Same |
| Bacterial Filtration
Efficiency
ASTMF2101 | Pass at ≥99% | Pass at ≥99% | Same |
| Differential
Pressure (Delta P)
MIL-M-36954C | Average 3.6
mmH2O/cm² | Average 3.7
mmH2O/cm² | Similar |
| Flammability
16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility
ISO 10993-5 and
ISO 10993-10 | Under the conditions of
the studies employed,
the device is non-
cytotoxic, non-
sensitizing, and non-
irritating. | Under the conditions of
the studies employed,
the device is non-
cytotoxic, non-
sensitizing, and non-
irritating. | Same |

8.0 Summary of 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.

Table of Conformity to Standards

StandardsName
ASTM
F1862/F1862M-17Standard Test Method for Resistance of Medical Face Masks to
Penetration by Synthetic Blood (Horizontal Projection of Fixed
Volume at a Known Velocity)
ASTM F2100-19Standard Specification for Performance of Materials Used in
Medical Face Masks
ASTM F2101-19Standard Test Method for Evaluating the Bacterial Filtration
Efficiency (BFE) of Medical Face Mask Materials Using a
Biological Aerosol of Staphylococcus aureus
MIL-M-36954CDifferential Pressure (Delta-P)
ASTM
F2299/F2299M-03Standard Test Method for Determining the Initial Efficiency of
Materials Used in Medical Face Masks to Penetration by
Particulates Using Latex Spheres
16 CFR PART 1610Standard for the flammability of clothing textiles

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| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity |
|--------------|----------------------------------------------------------------------------------------------------|
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for
Irritation and skin sensitization |

8

| Standards | Disposable Surgical
Mask
Ear Loop | Acceptance Criteria | Result |
|-----------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------|--------|
| Resistance to
penetration by
synthetic blood
ASTM F1862 | 32 out of 32 passed in
160 mm Hg | 29 out of 32 passed in
160 mm Hg | Pass |
| Sub-micron
particulate filtration
efficiency at
0.1 micron
ASTM F2299 | ≥99% | ≥98% | Pass |
| Bacterial filtration
efficiency
ASTM F2101-19 | ≥99% | ≥98% | Pass |
| Differential pressure
MIL-M-36954 | Average 3.7
mmH₂O/cm² |