Medical Surgical Mask (Model: JM92, JM92B)

K220187 · Guangdong Jia Mei Biological Technology Co.Ltd · FXX · Mar 25, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220187
• Device Name: Medical Surgical Mask (Model: JM92, JM92B)
• Applicant: Guangdong Jia Mei Biological Technology Co.Ltd
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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 Story

Flat-pleated, single-use, non-sterile surgical mask; three-layer construction (polypropylene spunbond outer/inner layers, melt-blown polypropylene filter layer). Features polyethylene-coated iron wire nose piece and spandex ear loops. Used in clinical settings by healthcare personnel and patients to reduce exposure to blood, body fluids, and microorganisms. Device acts as physical barrier; performance verified against ASTM F2100 standards for bacterial/particulate filtration, differential pressure, fluid resistance, and flammability. Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10. No active components or software.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F2101 (BFE), ASTM F2299 (PFE), ASTM F1862 (fluid resistance), EN 14683 (differential pressure), and 16 CFR Part 1610 (flammability). Biocompatibility verified via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Three-layer mask: polypropylene spunbond (outer/inner), melt-blown polypropylene (filter). Nose piece: polyethylene-coated iron wire. Ear loops: spandex. Dimensions: 17.5 cm x 9.5 cm. Non-sterile, single-use. ASTM F2100 Level 1 (JM92B) and Level 3 (JM92) performance specifications.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material in infection control practices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) (K212293)
• Surgical mask (Model: SMDP20608) (K211552)

Submission Summary (Full Text)

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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.

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.

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

#### 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: [phone] Email: [e-mail]

#### 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<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company | Guangdong Jia Mei<br>Biological<br>technology Co.Ltd | Jiangmen Ningrui Medical<br>Supplies Co., Ltd. | Shandong<br>Shengquan New<br>Materials Co., Ltd. | -- |
| 510 (k) | Applying | K212293 | K211552 | -- |
| Trade Name | MEDICAL<br>SURGICAL MASK | Surgical Mask | Surgical mask | -- |
| Model | JM92, JM92B | WK1701-02A, WK1701-03A,<br>WK1701-04A | SMDP20608 | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Surgical Apparel | SE |
| Classification | Class II | Class II | Class II | SE |
| Product Code | FXX | FXX | FXX | SE |
| Intended use | The MEDICAL<br>SURGICAL MASK<br>is intended to be<br>worn to protect both<br>the patient and<br>healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids, and<br>particulate material.<br>These face masks<br>are intended for use | The Surgical Mask is intended<br>to be worn to protect both the<br>patient and healthcare<br>personnel from the transfer of<br>microorganisms, body fluids,<br>and particulate material. The<br>Surgical Mask is intended for<br>use in infection control<br>practices to reduce the potential<br>exposure to blood and body<br>fluids. This is a single-use,<br>disposable device(s), provided<br>non-sterile. | The surgical masks<br>are intended to be<br>worn to protect both<br>the patient and<br>healthcare personnel<br>from transfer of<br>microorganisms,<br>body fluids and<br>particulate material.<br>These surgical<br>masks are intended<br>for use in infection<br>control practices to | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| | in infection control<br>practices to reduce<br>the potential<br>exposure to blood<br>and body fluids. This<br>is a single-use,<br>disposable device,<br>provided non-sterile. | reduce the potential<br>exposure to blood<br>and body fluids. This<br>is a single use,<br>disposable device,<br>and provided non-sterile. | | |
| Materials | | | | |
| Outer facing<br>layer | Polypropylene<br>spunbond | Polypropylene spunbond fabric | Polypropylene<br>Spunbond | SE |
| Middle filter<br>layer | Melt blown<br>polypropylene | Polypropylene meltblown fabric | Melt blown<br>polypropylene filter | SE |
| Inner facing<br>layer | Polypropylene<br>spunbond | Polypropylene spunbond fabric | Polypropylene<br>Spunbond | SE |
| Nose piece | Polyethylene coated<br>iron wire | Polypropylene coated<br>galvanized iron wire | Malleable<br>polyethylene | SE<br>Note 1 |
| Ear loops | Spandex | Nylon, spandex | Spandex, Polyester | SE<br>Note 1 |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | SE |
| Color | Blue (JM92), Black<br>(JM92B) | Blue | Black and White | SE |
| Dimensions | Length: 17.5 cm<br>$\pm$ 5%<br>Width: 9.5 cm $\pm$ 5% | Length: 17.5 cm $\pm$ 5mm<br>Width: 9.5 cm $\pm$ 3mm | Length:<br>17.5cm $\pm$ 0.88cm<br>Width:<br>9.5cm $\pm$ 0.48cm | SE |
| OTC use | Yes | Yes | Yes | SE |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | SE |
| Single-use | Yes | Yes | Yes | SE |
| Performance<br>Testing | Level 1, Level 3 | Level 1; Level 2; Level 3 | Level 3 | SE |
| Level | Level 1<br>(JM92B) | Level 1 | Level 3 | / |
| Fluid | Pass at | Pass at | Passed at 29 out of | SE |

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| Elements of Comparison | Subject Device | Predicate Device 1 | | | Predicate Device 2 | Remark |
|------------------------------------------------|--------------------------|--------------------------|--------------------------|--------------------------|--------------------------|---------------------------------|
| Resistance Performance (ASTM F1862) | 80 mmHg | 160 mmHg | 80 mm Hg | 120 mm Hg | 160 mm Hg | 32 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 < 5.0 mm H2O/cm² | Pass at < 6.0 mm H2O/cm² | Pass at < 3.4 mmH2O /cm² | Pass at < 3.5 mmH2O /cm² | Pass at < 3.4 mmH2O /cm² | <6.0 mm H2O/cm² SE Note 2 |
| Flammability | Class 1 | Class 1 | Class 1 | | | SE |
| Biocompatibility | Cytotoxicity | Non-cytotoxic | Non-cytotoxic | | | Conform to ISO 10993-5:2009 SE |
| | Irritation | Non-irritating | Non-irritating | | | Conform to ISO 10993-10:2010 SE |
| | Sensitization | Non-sensitizing | Non-sensitizing | | | Conform to ISO 10993- SE |

# Comparison in Detail(s):

# Note 1:

Although the "Nose piece" and "Ear loops" of subject device are a little different from predicate devices,

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they all met the requirements of biocompatibility standard ISO 10993-5 and ISO 10993-10. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

# Note 2:

Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is a little different from predicate devices, they all met the requirements of performance standard ASTM F2100. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

#### 9. Summary of Non-Clinical Performance Testing

| | | Pass criteria | | Test<br>results<br>/Verdict |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------|-----------------------------|
| Test item | Test method | For Level<br>1 | For Level<br>3 | |
| Bacterial<br>filtration<br>efficiency | ASTM F2101-19 Standard Test<br>Method for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of Medical<br>Face Mask Materials, Using a<br>Biological Aerosol of Staphylococcus<br>aureus according to ASTM F2100:<br>2019 | ≥ 95% | ≥ 98% | Pass |
| Differential<br>pressure<br>(Delta-P) | EN 14683: 2019, Annex C Medical<br>face masks - Requirements and test<br>methods according to ASTM F2100:<br>2019 | <5.0 mm<br>H2O/cm² | <6.0 mm<br>H2O/cm² | Pass |
| Sub-micron<br>particulate<br>filtration<br>efficiency at 0.1<br>µm of<br>Polystyrene<br>Latex Spheres | ASTM F2299 Standard Test Method<br>for Determining the Initial Efficiency of<br>Materials Used in Medical Face Masks<br>to Penetration by Particulates Using<br>Latex Spheres according to ASTM<br>F2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Resistance to<br>penetration by | ASTM F1862/F1862M-17<br>Standard Test Method for Resistance of | Pass<br>at 80 mm | Pass<br>at 160 mm | Pass |

## Performance Testing summary

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| synthetic blood,<br>minimum<br>pressure in mm<br>Hg for pass<br>result | Medical Face Masks to Penetration by<br>Synthetic Blood (Horizontal Projection of<br>Fixed Volume at a Known Velocity)<br>according to ASTM F2100:2019 | Hg | Hg | |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|------|
| Flame spread | 16 CFR Part 1610 Standard for the<br>Flammability of Clothing according to<br>ASTM F2100:2019 | Class 1 | Class 1 | Pass |

## Biocompatibility Testing

According to ISO 10993-1: 2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-prolonged (<24 h). 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.

### 10. Summary of Clinical Performance Test

No clinical study is included in this submission.

### 11. Final Conclusion:

The conclusion drawn from the nonclinical tests demonstrate that the subject device MEDICAL SURGICAL MASK (Model: JM92, JM92B) is substantially equivalent to the legally marketed devices identified in K212293 and K211552.