Disposable surgical mask

K220532 · Xiamen Blue Star Enterprise Co., Ltd. · FXX · May 23, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220532
• Device Name: Disposable surgical mask
• Applicant: Xiamen Blue Star Enterprise Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: May 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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. This is a single use, disposable device(s), provided non-sterile.

Device Story

Disposable, three-layer, flat-pleated surgical mask; intended for single use. Construction: outer/inner layers of spun-bond polypropylene; middle layer of melt-blown polypropylene filter. Features elastic spandex ear loops and polyethylene nose clip for facial fit. Provided non-sterile. Used in clinical settings by healthcare personnel and patients to provide a physical barrier against blood, body fluids, and particulates. Protects both wearer and patient from cross-contamination.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration efficiency >98%), ASTM F2101 (bacterial filtration efficiency >99%), and MIL-M-36954C (differential pressure <5.0 mmH2O/cm²). Biocompatibility testing (ISO 10993-5, 10993-10) confirmed non-cytotoxic, non-irritating, and non-sensitizing properties. Flammability tested per 16 CFR 1610 (Class 1).

Technological Characteristics

Three-layer non-woven polypropylene construction. Middle layer: melt-blown polypropylene filter. Nose clip: polyethylene. Ear loops: spandex. Dimensions: 17cm x 9.5cm. Non-sterile. Standards: ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings.

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 (K182515)

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.

May 23, 2022

Xiamen Blue Star Enterprise Co., Ltd. % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co.,Ltd. 609 Room,No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China

Re: K220532

Trade/Device Name: Disposable surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 5, 2021 Received: February 24, 2022

Dear Sam Lin:

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

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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,

for

Brent 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) K220532

Device Name Disposable surgical mask

Indications for Use (Describe)

The Disposable surgical masks are intended to be worn to protect 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(s), provided non-sterile.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Research Use (21 CFR 201.26) | <input checked="" type="checkbox"/> Sample Use (21 CFR 201.26) |
|-------------------------------------------------------|----------------------------------------------------------------|
|-------------------------------------------------------|----------------------------------------------------------------|

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Type of submission | Traditional |
|---------------------------|-------------------------------------------------|
| Date prepared | July 5, 2021 |
| Submission sponsor | |
| Manufacturer Name | Xiamen Blue Star Enterprise Co., Ltd. |
| Address | Room 201, South Building, No.506, Haiming Road, |
| | Maxiang Town, Xiang'an District, Xiamen, China |
| Tel | 86-13015920500 |
| Email | [e-mail] |
| Contact Person | Jincong Zhang |
| Device identification | |
| Trade Name | Disposable surgical mask |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Name | Mask, Surgical |
| Device Classification | Class II |
| Product Code | FXX |
| Panel | General Hospital |
| Previous Submissions | None |
| Application correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New |
| | District, Shanghai, China |
| Tel | 86-18717927910 |
| Email | [e-mail] |
| Contact Person | Sam Lin |

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### Predicate device information

| Sponsor | WUHAN DYMEX HEALTHCARE CO., LTD. |
|-------------------|----------------------------------|
| Trade/Device Name | SURGICAL FACE MASK |
| 510(K) number | K182515 |
| Regulation Number | 21 CFR 878.4040 |

### 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. This is a single use, disposable device(s), provided non-sterile.

### Device description

The Disposable surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

### Performance Testing - Clinical

Not Applicable.

### Performance Testing - Animal

Not Applicable.

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510(K) Summar

# echnological Characteristic Compariso

Provided below is a comparison of the subject device with the predicate device

## able 6A: General Compariso

| | Proposed Device | Predicate Device | Differences |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | | Discussion |
| Device name | Disposable surgical mask | SURGICAL FACE MASK | N/A |
| 510(k) number | | K182515 | N/A |
| Manufacturer | Xiamen Blue Star Enterprise Co., Ltd. | Wuhan Dymex Healthcare Co., Ltd | N/A |
| Product regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification name | Mask, Surgical | Mask, Surgical | Same |
| Regulation class | 2 | 2 | Same |
| Product code | FXX | FXX | Same |
| Indications for use | The Disposable surgical masks are intended to be<br>worn to protect both the patient and healthcare<br>personnel from transfer of microorganisms, body<br>fluids and particulate material. These face masks | The Surgical Face Masks are intended to be worn<br>to protect both the patient and healthcare personnel<br>from transfer of microorganisms, body fluids and<br>particulate material. These face masks are intended | Same |
| | Rx or OTC | | |
| | 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(s), provided non-sterile. | are intended for use in infection control practices 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. | Same |
| | OTC | OTC | Same |
| | Model | | |
| | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same |
| Material | | | |
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose clip | Polyethylene | Malleable polyethylene wire | Similar |
| Ear loops | Spandex | Spandex | Same |
| Color | Blue | Blue | Same |
| Dimension | 17cm X 9.5cm | 17.5cm X 9cm | Similar |
| Sterility | Non-Sterile | Non-Sterile | Same |

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K220532

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510(K) Summary

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K220532

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| Use | Single Use, Disposable | | Single Use, Disposable | | Same |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------|-------------------------------|--------|------|
| <b>Summary of Non-Clinical Testing</b> | | | | | |
| Provided below is a summary of the performance testing of the subject devices to demonstrate that the device meets the specification or acceptance criteria of the standards and test methods shown below. | | | | | |
| Table 6B: Comparison of Non-clinical testing | | | | | |
| Item | | Proposed device | Acceptance Criteria | Result | |
| Fluid<br>ASTM F1862 | Resistance | Performance 3 non-consecutive lots tested | 29 out of 32 pass at 120 mmHg | Pass | |
| Particulate<br>ASTM F2299 | Filtration | Efficiency 3 non-consecutive lots tested<br>Lot1: 98.43%<br>Lot2: 98.18%<br>Lot3: 98.54% | ≥ 98% | Pass | |
| Bacterial<br>ASTM F2101 | Filtration | Efficiency 3 non-consecutive lots tested<br>Lot1: 99.9%<br>Lot2: 99.9%<br>Lot3: 99.9% | ≥ 98% | Pass | |
| Differential<br>MIL-M-36954C | Pressure (Delta P) | 3 non-consecutive lots tested<br>Lot1: 3.5mmH2O/cm²<br>Lot2: 3.1mmH2O/cm² | < 5.0mmH2O/cm² | Pass | |

### 510(K) Summary

Level 2

Level 2

Level

Similar

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| 510(K) Summary | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|------|
| | Lot3: 3.3mmH2O/cm² | | |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Pass |
| Irritation | Under the conditions of the study, the device is non-irritating | Under the conditions of the study, the device is non-irritating | Pass |
| Sensitization | Under the conditions of the study, the device is non-sensitizing | Under the conditions of the study, the device is non-sensitizing | Pass |
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| Non-Clinical Test Conclusion | | | |
| Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: | | | |
| 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles; | | | |
| ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of | | | |

0(K) Summa

- xed Volume at a Known Veloci
- ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Face Masks ration by Particulates using Latex Sphere ●
- ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Usin Biological Aerosol of Staphylococcus aureu ●

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- fferential Pressure -Determine breathing resistance or differential pressure as directed in EN 14683:2019, Annex
- M F2100-2019 Standard Specification for Performance of Materials Used in Medical Face Mas ●
- 0993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotox ●
- 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitizatio .

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### Conclusion

Based on the indications for use, general information, and non-clinical performance data, "Disposable surgical mask" is as safe, as effective, and performs as well as the legally marketed predicate devices, "SURGICAL FACE MASK (K182515)". Therefore, the subject device is substantially equivalent to the predicate device.