K Number
K210042
Device Name
Disposable Surgical Mask
Date Cleared
2021-11-17

(314 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical Masks 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. The Disposable Surgical Masks are single use, disposable device, provided non-sterile.
Device Description
Disposable Surgical Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (High-density Polyethylene) to provide a firm fit over the nose. There are four models for Disposable Surgical Mask with different colors and sizes. All six models are Ear Loop type in blue or white colors and two sizes including 145mm×90mm and 175×95mm.
More Information

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.
A surgical mask is a barrier device for infection control, not a device intended to treat or cure a disease or medical condition.

No

The device is a surgical mask intended for protection against transfer of microorganisms and fluids, not for diagnosing medical conditions.

No

The device description clearly outlines a physical product made of multiple layers of material with ear loops and a nose piece. The performance studies focus on physical properties like filtration efficiency, pressure resistance, and flammability, not software metrics.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Description and Intended Use: The description and intended use clearly state that the Disposable Surgical Masks are worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. They are a physical barrier device.
  • Lack of Diagnostic Function: The device does not perform any tests on biological samples to provide diagnostic information.
  • Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, breathability, fluid resistance, flammability, biocompatibility) and not on diagnostic accuracy or analytical performance.

The information provided describes a standard medical device used for personal protection and infection control, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Disposable Surgical Masks 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. The Disposable Surgical Masks are single use, disposable device, provided non-sterile.

Product codes

FXX

Device Description

Disposable Surgical Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (High-density Polyethylene) to provide a firm fit over the nose.

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

Not Found

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 tests were conducted to verify that the proposed device met all design specifications found in the test methodology and standard using 3 nonconsecutive lots. The test results demonstrated that the Disposable Surgical Masks complies with the following standards:

  • ASTM F2100-19 Standard Specification for Performance of Materials Used ● in Medical Face Masks
  • ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to . Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
  • EN 14683:2019+AC2019(E) Annex C ●
    ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
  • . ASTM F2101 Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Page 7 of 9
    Aerosol of Staphylococcus aureus
  • MIL-M- 36954C Military Specification, Mask, Surgical, Disposable .
  • 16 CFR Part 1610 Standard for the Flammability of Clothing ●
  • ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
  • . ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
  • ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization

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

Test MethodologyPurposeAcceptance CriteriaResults
Bacterial Filtration EffciencyThe test was performed in accordance with ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical FaceMask Materials, Using a Biological Aerosol of Staphylococcus aureus to determine the bacterial filtration efficiency(BFE) ofLevel 2>=98%32/32 Passed at >=99.9%
Particulate Filtration EfficiencyThe test was performed in accordance with ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres to determine the particle filtration efficiency (PFE) ofLevel 2>=98%32/32 Pass at >=99.5%
Differential Pressure (delta-P)The test was performed in accordance with EN 14683:2019+AC;2019(E) Annex CLevel 2

§ 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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November 17, 2021

Suzhou Letian Protective Products Co., Ltd. % Ryan Li RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China

Re: K210042

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 22, 2021 Received: September 29, 2021

Dear Ryan Li:

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 (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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210042

Device Name

Disposable Surgical Mask, Blue(Model; LT-0175A, LT-0145A) Disposable Surgical Mask, White (Model: LT-0175B, LT-0145B)

Indications for Use (Describe)

The Disposable Surgical Masks 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. The Disposable Surgical Masks are 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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510(K) Summary-K210042

I. SUBMITTER:

Suzhou Letian Protective Products Co., Ltd. No. 12 Zhenfeng Road, Nanfeng Town, Suzhou City, Jiangsu Province, 215600, China

Contact Person: Huang Qizhi Title: Integrated Manager Tel: +86 13701567601

Email: huangqizhi@szltfhypwwgc.onexmail.com

Submission Correspondent: Ryan Li Email: ryan.li(@mind-link.net Tel:+86 13701581791

Summary prepared: September 17th, 2021

II. DEVICE

Name of Device: Disposable Surgical Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II

Product Code: FXX

III. PREDICATE DEVICE

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Primary predicate device: Surgical Face Masks (K182514)

IV. REFERENCE DEVICE

Reference device: Face Mask (K210007)

V. DEVICE DESCRIPTION

Disposable Surgical Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (High-density Polyethylene) to provide a firm fit over the nose.

There are four models for Disposable Surgical Mask with different colors and sizes. All six models are Ear Loop type in blue or white colors and two sizes including 145mm×90mm and 175×95mm.

VI. AVAILABLE MODELS

REF No.ProductModel DescriptionMask Color
SizeMaskEar LoopBlueWhite
LT-0145A145×90mmXXX
LT-0175A175×95mmXXX
LT-0145B145×90mmXXX
LT-0175B175×95mmXXX

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VII. INDICATIONS FOR USE

The Disposable Surgical Masks 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. The Disposable Surgical Face Masks are single use, disposable device, provided non-sterile.

VIII. TECHNOLOGICAL CHARACTERISTICS COMPARISON

The Disposable Surgical Masks are compared with the predicate device (Surgical Face Masks (K182514)):

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DeviceSubject DevicePrimary Predicate Device
Disposable Surgical Mask
(K210042)Surgical Face Mask
(K182514 )Comparison
Intended UseThe Disposable Surgical Face Masks
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. The Disposable Surgical
Face Masks are single use, disposable
device, provided non-sterile. | The surgical face masks 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,
provided non-sterile. | Same |
| Classification
Product Code | FXX | FXX | Same |
| Ear Loop
Model | Ear Loops | Ear Loops | Same |
| Outer Facing Layer | Spun-bond
polypropylene
non-woven fabric | Spun-bond polypropylene | Similar Note 1 |
| Middle Layer | Melt-blown polypropylene | Melt blown polypropylene
filter | Similar
Note 1 |
| Inner Facing Layer | Spun-bond
polypropylene
non-woven fabric | Spun-bond polypropylene | Similar Note 1 |
| Nose Piece | High-density polyethylene | Malleable aluminum wire | Similar
Note 1 |
| Ear Loops | 80% Spandex
20% Polyester | Polyester | Similar Note 1 |
| Color | Blue, white | White | Different Note 1 |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple
Layers | 3 Layers | 3 Layers | Same |
| Single Use | Single use | Single use | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Length $\times$ Width | $145 \times 95$ mm ( $\pm$ 10mm)
$175 \times 95$ mm ( $\pm$ 10mm) | Length: 95 $\pm$ 10mm
Width:175 $\pm$ 10mm | Different Note 2 |
| Fluid Resistance
ASTM F1862 | 32 out of 32 pass at
120mmHg | 32 out of 32 pass at
120mmHg | Same |
| Particulate Filtration
Efficiency (PFE) ASTM
F2299 | Pass at $\ge$ 99.5% | Pass at 99.88% | Similar |
| Bacterial Filtration
Efficiency (BFE) ASTM
F2101 | Pass at $\ge$ 99.9% | Pass at 99.6% | Similar |
| Differential Pressure
(Delta P)
MIL-M-36954
C | Pass at $