Disposable Surgical Mask

K202126 · Shenzhen Peninsula Medical Co., Ltd. · FXX · Jun 8, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202126
• Device Name: Disposable Surgical Mask
• Applicant: Shenzhen Peninsula Medical Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Device Story

Disposable surgical mask; flat pleated style; worn by operating room personnel during surgical procedures. Protects patient and personnel from microorganisms, body fluids, and particulates. Three-layer construction: inner/outer layers spun-bond polypropylene; middle layer melt-blown polypropylene filter. Features malleable aluminum nose piece and elastic polyester ear loops. Single-use, non-sterile, disposable. User fits mask over nose and mouth using ear loops and nose piece. Provides barrier protection; performance meets ASTM F2100-19 Level 1 standards.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19 Level 1 requirements: Bacterial Filtration Efficiency (≥95%), Differential Pressure (<5.0 mm H2O/cm²), Sub-micron Particulate Filtration Efficiency (≥95%), Synthetic Blood Penetration (80 mmHg), and Flammability (Class 1). Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Three-layer mask: spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter). Malleable aluminum wire nose piece. Polyester ear loops. Dimensions: 17.5cm x 9.5cm. Non-sterile. Single-use. Performance meets ASTM F2100-19 Level 1. Biocompatibility per ISO 10993-1, 5, and 10.

Indications for Use

Indicated for operating room personnel to protect the surgical patient and personnel from transfer of microorganisms, body fluids, and particulate material during surgical procedures.

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 Face Mask with Ear-Loop (K123115)

Submission Summary (Full Text)

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June 8, 2021

Shenzhen Peninsula Medical 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: K202126

Trade/Device Name: Disposable Surgical Mask (Model: Flat-type) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 28, 2021 Received: May 11, 2021

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ryan Ortega, PhD 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

Enclosure

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# Indications for Use

510(k) Number (if known) K202126

Device Name Disposable Surgical Mask (Model: Flat-type)

Indications for Use (Describe)

Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

| 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 for K202126

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

510(k) Owner's Name: Shenzhen Peninsula Medical Co. Ltd. Establishment Registration Number: 3016746323 Address: 3F Block A, Building F2, Changfeng Industrial Park, Liuxian 3rd Road, 68# Xin'an Street, Bao'an District, Shenzhen, 518100, P.R.China. Contact Person: Zhang Sudi Email: [e-mail]

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

## 2. Date of the summary prepared: June 8, 2021

## 3. Subject Device Information

Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Surgical Mask Model Name: Flat-type Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II

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#### 4. Predicate Device Information

Sponsor: Acme Filter Mask Inc. Trade Name: Surgical Face Mask with Ear-Loop Classification Name: Mask, Surgical Common name: Surqical Mask 510(K) Number: K123115 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II

#### 5. Device Description

The Disposable Surgical Mask is Flat Pleated style mask, utilizing ear loops way for wearing, and they all has nose piece design for fitting the Disposable Surgical Mask around the nose.

The Disposable Surgical Mask are manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8) and the middle layer is made of melt blown polypropylene filter.

The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the Disposable Surgical Mask. The elastic ear loops are not made with natural rubber latex.

The nose piece contained in the Disposable Surgical Mask is in the middle layer of Disposable Surgical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of malleable aluminum wire.

The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Surgical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.

The Disposable Surgical bag packaging material is Polypropylene and box packaging are carton.

### 6. Intended Use / Indications for Use

Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

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| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Shenzhen Peninsula Medical Co.<br>Ltd. | Acme Filter Mask Inc. | -- |
| 510 (k) | K202126 | K123115 | -- |
| Trade Name | Disposable Surgical Mask | Surgical Face Mask with Ear-Loop | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21<br>CFR 878.4040) | Class II Device, FXX (21<br>CFR 878.4040) | Same |
| Intended use | Disposable Surgical Mask is<br>Device that is intended to be worn<br>by operating room personnel<br>during surgical procedures to<br>protect both the surgical patient<br>and the operation room personnel<br>from transfer of microorganisms,<br>body fluids and particulate<br>material. | Surgical Face Mask is Device that<br>is intended to be worn by operating<br>room personnel during surgical<br>procedures to protect both the<br>surgical patient and the operation<br>room personnel from transfer of<br>microorganisms, body fluids and<br>particulate material. | Same |
| Material | | | |
| Outer facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Same |
| Ear loops | Polyester | Polyester | Same |
| Design | Color: Blue | Color: Blue | Same |
| features | Ear loops | Ear loops | Same |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification | Length: 17.5cm+1cm | Length: 17.5cm+1cm | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| and<br>Dimension | Width: 9.5cm±1cm | Width: 9.5cm±1cm | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance<br>Testing | Level 1 | Level 1 | Same |
| Fluid<br>Resistance<br>Performance | Pass at 80 mmHg | Fluid Resistance | Different<br>Note 1 |
| Particulate<br>Filtration<br>Efficiency | ≥ 95% | Average 94.79% for Solid Aerosol<br>Filtration Efficiency<br>Efficiency More than 99.5% for<br>Viral Filtration Efficiency | Different<br>Note 1 |
| Bacterial<br>Filtration<br>Efficiency | ≥ 95% | pass at 99.9% | Different<br>Note 1 |
| Differential<br>Pressure | < 5.0 mm H2O/cm² | pass at 3.3 mm H2O/cm² | Different<br>Note 1 |
| Flammability | Class 1 | Class 1 | Same |
| Shelf life | 2 years | Not public | Different<br>Note 2 |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the study,<br>the subject device extract was<br>determined to be non-cytotoxic. | Under the conditions of the study,<br>the subject device extract was<br>determined to be non-cytotoxic. | Same |
| Irritation | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined to<br>be non-irritating. | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined to<br>be non-irritating. | Same |
| Sensitization | Under the conditions of the study,<br>the subject device non-polar and | Under the conditions of the study,<br>the subject device non-polar and | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| | polar extracts were determined to<br>be non-sensitizing. | polar extracts were determined to<br>be non-sensitizing. | |

# 7. Comparison to predicate device and conclusion

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### Comparison in Detail(s):

### Note 1:

Although the "Fluid Resistance Performance", "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM F2100-19 level 1. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device when used as labeled.

### Note 2:

Although the "Shelf life" of the subject device is different from the predicate device, the aging test showed that the requirements of essential performance standard ASTM F2100-19 level 1. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.

## 8. Summary of Non-Clinical Performance Testing

- Performance Testing summary

| Test item<br>(Performance<br>Level 1) | Test method | Pass criteria | Test results<br>/Verdict |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------------|
| Bacterial filtration<br>efficiency | ASTM F2101-14<br>Standard Test<br>Method for<br>Evaluating the<br>Bacterial Filtration<br>Efficiency (BFE) of<br>Medical Face<br>Mask Materials,<br>Using a Biological<br>Aerosol of | ≥ 95% | 32/32 Passed at<br>≥95% / Pass |
| | Staphylococcus<br>aureus according<br>to ASTM<br>F2100:2019 | | |
| Differential<br>pressure (Delta-P) | EN 14683: 2019,<br>Annex C Medical<br>face masks -<br>Requirements and<br>test methods<br>according to ASTM<br>F2100:2019 | <5.0 mm H2O/cm² | 32/32 Passed at<br><5 mmH2O/cm² /<br>Pass |
| Sub-micron<br>particulate filtration<br>efficiency<br>at 0.1 µm of<br>Polystyrene Latex<br>Spheres | ASTM F2299-03<br>Standard Test<br>Method for<br>Determining the<br>Initial Efficiency of<br>Materials Used in<br>Medical Face<br>Masks to<br>Penetration by<br>Particulates Using<br>Latex Spheres<br>according to ASTM<br>F2100:2019 | ≥ 95% | 32/32 Passed at<br>≥95% / Pass |
| Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in mm Hg<br>for pass result | ASTM<br>F1862/F1862M-17<br>Standard Test<br>Method for<br>Resistance of<br>Medical Face Masks<br>to Penetration by<br>Synthetic Blood<br>(Horizontal Projection<br>of Fixed Volume at a | Fluid resistant<br>claimed<br>at 80 mm Hg | 32/32 Passed at<br>80 mmHg/ Pass |
| | Known Velocity)<br>according to ASTM<br>F2100:2019 | | |
| Flame spread | 16 CFR Part 1610<br>Standard for the<br>Flammability of<br>Clothing according<br>to ASTM<br>F2100:2019 | Class 1 | 32/32 Passed ≥3<br>Seconds burn<br>Time-Class 1 /<br>Pass |

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#### ● Biocompatibility Testing

According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

| Title of the test | Purpose of the test | The source of references (Test method) | Acceptance criteria | Test results |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------|
| In vitro Cytotoxicity Test | Under the research conditions, determine whether the target device extract is cytotoxic. | ISO 10993-5:2009<br>Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | Under the research conditions, determine whether the non-polar and polar extracts of the target device are sensitive. | ISO 10993-10:2010<br>Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | Under the research conditions, determine whether the non-polar and polar | ISO 10993-10:2010<br>Biological evaluation of medical devices— Part 10: Tests for irritation | Under the conditions of the study, the subject device non-polar and polar | Pass |

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| | extracts of the target | and skin sensitization | extracts were | |
|--|------------------------|------------------------|------------------|--|
| | device are irritating. | | determined to be | |
| | | | non-irritating. | |

### 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 in 510(K) submission K202126, the Disposable Medical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K123115.