K Number
K201622
Device Name
Medical surgical mask
Date Cleared
2020-11-24

(162 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
Device Description
The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene. Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin. The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.
More Information

Not Found

No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a standard surgical mask. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

No
A therapeutic device is used to treat or cure a disease or condition. This device is described as a surgical mask intended for protection against the transfer of microorganisms, bodily fluids, and particulate matter, not for treatment.

No

The device description clearly states it is a "Medical surgical mask" intended to protect against transfer of microorganisms and bodily fluids. It does not mention any function for diagnosing conditions or diseases.

No

The device description clearly outlines a physical product (a mask) made of various materials and with specific dimensions, indicating it is a hardware device, not software.

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

Here's why:

  • Intended Use: The intended use is to protect healthcare workers and patients against the transfer of microorganisms, bodily fluids, and particulate matter during procedures. This is a barrier function, not a diagnostic one.
  • Device Description: The description details the physical construction and materials of a surgical mask. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
  • Performance Studies: The performance studies focus on the physical and filtration properties of the mask (bacterial filtration efficiency, differential pressure, particulate filtration efficiency, resistance to synthetic blood, flame spread) and biocompatibility. These are relevant to the protective function of a mask, not to diagnostic testing.

IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This surgical mask does not perform any such function.

N/A

Intended Use / Indications for Use

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

Product codes

FXX

Device Description

The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose.

The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene.

Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex.

The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin.

The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm.

The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.

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

healthcare workers

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)

Performance Testing summary

Test item (Performance Level 1)Test methodPass criteriaTest results/Verdict
Bacterial filtration efficiencyASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019≥ 95%99.2% / Pass
Differential pressure (Delta-P)EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:201924 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
  1. In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity,
  2. Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization,
  3. Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.

No clinical study is included in this submission.

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

  • Bacterial filtration efficiency: 99.2%
  • Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres: 99.46%

Predicate Device(s)

K153409

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 24, 2020

Guangdong KINGFA Sci.&Tech.Co.,Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China

Re: K201622

Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 15, 2020 Received: October 22, 2020

Dear Cassie Lee:

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); 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.

For CAPT Elizabeth Claverie Assistant Director DHT4B: Division of Health Technology 4B OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K201622

Device Name

Medical surgical mask (Model: KF-B P05)

Indications for Use (Describe)

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters This device is single use and provided non-sterile.

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary

510(k) Summary for K201622

1. Submitter's Information

510(k) Owner's Name: Guangdong KINGFA SCI.&TECH.Co.,Ltd.

Address: 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China

Post Code: 511500

Contact Person: Yu Xiaoge

Tel: +86 2632 8999

Fax: +0763-3203108

Email: yuxiaoge@kingfa.com.cn

Application Correspondent:

Contact Person: Ms. Cassie Lee

Share Info (Guangzhou) Medical Consultant Ltd.

Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China

Tel: +86 20 8266 2446

Email: regulatory@glomed-info.com

2. Date of the summary prepared: June 10, 2020

Revision date: November 24, 2020

3. Subject Device Information

Type of 510(k): Traditional

Classification Name: Mask, Surgical

4

Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary

Common name: Surgical Mask

510(K) Number: K201622

Trade Name: Medical surgical mask

Model Name: KF-B P05

Review Panel: Surgical Apparel

Product Code: FXX

Regulation Number: 878.4040

Regulatory Class: 2

4. Predicate Device Information

Sponsor: Protect U Guard, LLC

Trade Name: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

Classification Name: Mask, Surgical

Common name: Surgical Mask

510(K) Number: K153409

Review Panel: Surgical Apparel

Product Code: FXX

Regulation Number: 878.4040

Regulation Class: 2

5. Device Description

The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose.

The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene.

5

Sponsor:Guangdong KINGFA SCI.&TECH.Co.,Ltd.
Subject Device:Medical surgical mask (Model: KF-B P05)
Document Name:510(k) summary

Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex.

The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin.

The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm.

The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.

6. Intended Use / Indications for Use

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

7. Comparison to predicate device and conclusion

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of

ComparisonSubject DevicePredicate DeviceVerdict
CompanyGuangdong KINGFA
SCI.&TECH.Co.,Ltd.Protect U Guard, LLC--
510 (k)K201622K153409--
Trade NameMedical surgical maskProtect U Guard Earloop and
Tie-On Mask (Blue, White or--
Elements of
ComparisonSubject DevicePredicate DeviceVerdict
Green)
Classification
NameMask, SurgicalMask, SurgicalIdentical
ClassificationClass II Device, FXX (21
CFR878.4040)Class II Device, FXX (21
CFR878.4040)Identical
Intended use/
Indications
for UseMedical surgical mask is
intended for use by healthcare
workers during procedures to
protect both patients and
healthcare workers against
transfer of microorganisms,
bodily fluids, and particulate
matters. This device is single
use and provided non-sterile.Earloop Mask and Tie-On Mask
is intended for use by healthcare
workers during procedures to
protect both patients and
healthcare workers against
transfer of microorganisms,
bodily fluids, and airborne
particles. This device is
single use and provided
non-sterile.Identical
Material
Outer facing
layerSpun-bond polypropyleneSpun-bond polypropyleneIdentical
Middle layerMelt blown polypropyleneMelt blown polypropyleneIdentical
Inner facing
layerSpun-bond polypropyleneSpun-bond polypropyleneIdentical
Nose piecePolypropylene and metallic ironAluminum stripSimilar
Note 1
Ear loopsPolyester and spandex elastic
bandUrethane elastic fiberSimilar
Note 1
Design
featuresColor: blueColor: Blue, White and GreenSimilar
Note 1
Elements of
ComparisonSubject DevicePredicate DeviceVerdict
Mask StyleEarloop
Flat PleatedEarloop or Tie-On
Flat PleatedIdentical
Specification
and
Dimension9.5cm x 17.5 cm9.5cm x 17.7 cmIdentical
OTC useYesYesIdentical
SterilityNon-SterileNon-SterileIdentical
UseSingle Use, DisposableSingle Use, DisposableIdentical
Performance
Testing
(according to
ASTM-2100:
  1. | Level 1 | Level 1 | Identical |
    | Fluid
    Resistance
    Performance | Pass at 80 mmHg | Pass at 80 mmHg | Identical |
    | Particulate
    Filtration
    Efficiency | 99.46% | 99.18% | Similar
    better
    Note 2 |
    | Bacterial
    Filtration
    Efficiency | 99.2% | 99.17% | Similar
    better
    Note 2 |
    | Differential
    Pressure | 24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

  2. In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity,

  3. Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization,

11

Sponsor:Guangdong KINGFA SCI.&TECH.Co.,Ltd.
Subject Device:Medical surgical mask (Model: KF-B P05)
Document Name:510(k) summary
  1. Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.

9. Summary of Clinical Performance Test

No clinical study is included in this submission.

10. Final Conclusion:

The conclusion drawn from the nonclinical tests demonstrates that the subject device Medical surgical mask in 510(k) K201622, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153409.