K Number
K220187
Device Name
Medical Surgical Mask (Model: JM92, JM92B)
Date Cleared
2022-03-25

(60 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL 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 subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.
More Information

Not Found

No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML technology.

No
Explanation: This device is a surgical mask intended for infection control by creating a barrier to protect against microorganisms and fluids. It does not provide any therapeutic effect or treatment for a disease or condition.

No

Explanation: The device is a surgical mask intended to protect against the transfer of microorganisms and body fluids. It is a protective barrier, not a diagnostic tool used to identify or determine the nature of a disease or condition.

No

The device description clearly outlines a physical mask made of various materials (polypropylene, iron wire) and includes performance testing related to filtration, pressure, and flame spread, indicating it is a hardware device.

No, 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 function.
  • Device Description: The description details the physical construction and materials of the mask. There are no components or mechanisms described that would be used to perform a diagnostic test on a sample from the human body.
  • Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, pressure resistance, flame spread, biocompatibility). These are relevant to its function as a protective barrier, not as a diagnostic tool.
  • Key Metrics: The key metrics measured (filtration efficiency, differential pressure, resistance to penetration) are all related to the mask's ability to filter and block substances, not to detect or measure substances in a biological sample.

An In Vitro Diagnostic (IVD) device is used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical mask does not perform any such function.

N/A

Intended Use / Indications for Use

The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL 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 subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire.

The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.

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 / infection control practices

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 Performance Testing:
Test items included Bacterial filtration efficiency (ASTM F2101-19), Differential pressure (EN 14683: 2019, Annex C and ASTM F2100: 2019), Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres (ASTM F2299 and ASTM F2100: 2019), Resistance to penetration by synthetic blood (ASTM F1862/F1862M-17 and ASTM F2100:2019), and Flame spread (16 CFR Part 1610 and ASTM F2100:2019). All tests resulted in "Pass".
Biocompatibility Testing:
Tests included In vitro Cytotoxicity Test per ISO 10993-5: 2009, Skin Sensitization Tests per ISO 10993-10: 2010, and Skin Irritation Tests per ISO 10993-10: 2010. These tests demonstrated that the device is biocompatible and safe for its intended use.
No clinical study was included in the submission.

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

Key metrics from non-clinical performance testing:

  • Bacterial filtration efficiency: ≥ 95% (Level 1), ≥ 98% (Level 3)
  • Differential pressure:

§ 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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March 25, 2022

Guangdong Jia Mei Biological technology Co.Ltd % Ms. Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China

Re: K220187

Trade/Device Name: Medical Surgical Mask (Model: JM92, JM92B) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: January 21, 2022 Received: January 24, 2022

Dear Ms. 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 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.

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220187

Device Name MEDICAL SURGICAL MASK (Model: JM92, JM92B)

Indications for Use (Describe)

The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL MASK is intended for use in infection control practices to reduce the posure 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)
Over-The-Counter Use (21 CFR 801 Subpart C)

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

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510(k) Summary

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

1. Submitter's Information

Sponsor Name: Guangdong Jia Mei Biological technology Co.Ltd Address: 3/F, Block 1, No.356 Qinglan Road, Jianghai, Jiangmen City, Guangdong Province, China Post Code: 529040 Contact name: Jiali Chen Tel: +86-0750-3835982 E-mail: jmjaymei@163.com

Application Correspondent:

Contact Person: Ms. Cassie Lee Company: 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@share-info.com

2. Date of the summary prepared: November 26, 2020

Revision date: January 21, 2022 3.

4. Subject Device Information

Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: MEDICAL SURGICAL MASK Model Name: JM92, JM92B Review Panel: General Hospital Product Code: FXX Regulation: 21 CFR 878.4040 - Surgical apparel Regulatory Class: II

5. Predicate Device Information

Predicate Device 1 (Primary Predicate):

Sponsor: Jiangmen Ningrui Medical Supplies Co., Ltd.

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Trade Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) Classification Name: Mask, Surgical 510(K) Number: K212293 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II

Predicate Device 2:

Sponsor: Shandong Shengquan New Materials Co., Ltd. Trade Name: Surgical mask (Model: SMDP20608) Classification Name: Surgical Apparel 510(K) Number: K211552 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II

6. Device Description

The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire.

The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.

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7. Intended Use / Indications for Use

The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL 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.

8. 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 Device 1Predicate Device 2Remark
CompanyGuangdong Jia Mei
Biological
technology Co.LtdJiangmen Ningrui Medical
Supplies Co., Ltd.Shandong
Shengquan New
Materials Co., Ltd.--
510 (k)ApplyingK212293K211552--
Trade NameMEDICAL
SURGICAL MASKSurgical MaskSurgical mask--
ModelJM92, JM92BWK1701-02A, WK1701-03A,
WK1701-04ASMDP20608--
Classification
NameMask, SurgicalMask, SurgicalSurgical ApparelSE
ClassificationClass IIClass IIClass IISE
Product CodeFXXFXXFXXSE
Intended useThe MEDICAL
SURGICAL MASK
is 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 useThe Surgical Mask is intended
to be worn to protect both the
patient and healthcare
personnel from the transfer of
microorganisms, body fluids,
and particulate material. The
Surgical 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(s), provided
non-sterile.The 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 surgical
masks are intended
for use in infection
control practices toSE
Elements of
ComparisonSubject DevicePredicate Device 1Predicate Device 2Remark
in infection control
practices to reduce
the potential
exposure to blood
and body fluids. This
is a single-use,
disposable device,
provided non-sterile.reduce the potential
exposure to blood
and body fluids. This
is a single use,
disposable device,
and provided non-sterile.
Materials
Outer facing
layerPolypropylene
spunbondPolypropylene spunbond fabricPolypropylene
SpunbondSE
Middle filter
layerMelt blown
polypropylenePolypropylene meltblown fabricMelt blown
polypropylene filterSE
Inner facing
layerPolypropylene
spunbondPolypropylene spunbond fabricPolypropylene
SpunbondSE
Nose piecePolyethylene coated
iron wirePolypropylene coated
galvanized iron wireMalleable
polyethyleneSE
Note 1
Ear loopsSpandexNylon, spandexSpandex, PolyesterSE
Note 1
Mask StyleFlat-pleatedFlat-pleatedFlat-pleatedSE
ColorBlue (JM92), Black
(JM92B)BlueBlack and WhiteSE
DimensionsLength: 17.5 cm
$\pm$ 5%
Width: 9.5 cm $\pm$ 5%Length: 17.5 cm $\pm$ 5mm
Width: 9.5 cm $\pm$ 3mmLength:
17.5cm $\pm$ 0.88cm
Width:
9.5cm $\pm$ 0.48cmSE
OTC useYesYesYesSE
SterilityNon-SterileNon-SterileNon-SterileSE
Single-useYesYesYesSE
Performance
TestingLevel 1, Level 3Level 1; Level 2; Level 3Level 3SE
LevelLevel 1
(JM92B)Level 1Level 3/
FluidPass atPass atPassed at 29 out ofSE

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Elements of ComparisonSubject DevicePredicate Device 1Predicate Device 2Remark
Resistance Performance (ASTM F1862)80 mmHg160 mmHg80 mm Hg120 mm Hg160 mm Hg32 pass at 160 mmHg
Particulate Filtration Efficiency (ASTM F1215)Pass at ≥ 95%Pass at ≥ 98%Pass at ≥ 99%Pass at ≥ 99%Pass at ≥ 99%≥98% SE Note 2
Bacterial Filtration Efficiency (ASTM F2101)Pass at ≥ 95%Pass at ≥ 98%Pass at ≥ 99%Pass at ≥ 99%Pass at ≥ 99%≥98% SE Note 2
Differential Pressure (ASTM F2100)Pass at