Disposable Surgical Face Mask

K210409 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · FXX · Jul 28, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210409
• Device Name: Disposable Surgical Face Mask
• Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.

Device Story

Disposable surgical face mask; three-layer, flat-pleated design with tie-on straps and malleable polyethylene nose piece. Inner/outer layers and ties made of spun-bond polypropylene; middle layer made of melt-blown polypropylene. Used in clinical settings or by general public for infection control; worn by placing over nose and mouth and securing ties. Acts as physical barrier to microorganisms, body fluids, and particulates. Provides protection to both wearer and patient. Single-use, non-sterile device.

Clinical Evidence

No clinical data. Bench testing only. Device demonstrated compliance with ASTM F2100-19 Level 3 requirements: BFE >98%, differential pressure <6.0 mmH2O/cm², PFE >98% at 0.1 micron, synthetic blood penetration resistance (31/32 passed at 160mmHg), and Class 1 flame spread. Biocompatibility testing (cytotoxicity, irritation, sensitization) performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Technological Characteristics

Three-layer flat-pleated mask. Materials: Spun-bond polypropylene (inner/outer/ties), melt-blown polypropylene (middle), malleable polyethylene wire (nose piece). Dimensions: 17.5x9.5cm, 17.5x9.0cm, 17.0x9.0cm, 14.5x9.5cm (±5% tolerance). Non-sterile, single-use. ASTM F2100-19 Level 3 performance.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material, and to reduce exposure to blood and body fluids 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

• Disposable Surgical Face Mask (K153496)

Submission Summary (Full Text)

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July 28, 2021

Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210409

Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 20, 2021 Received: June 28, 2021

Dear Boyle Wang:

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.

For Clarence Murray 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) K210409

Device Name Disposable Surgical Face Mask

#### Indications for Use (Describe)

The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.

| 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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# K210409 510(k) Summary

510k number: K210409 Date: July 26, 2021 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

#### 1.0 Submitter's information

Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Contact: Mr. Junhui Zhu Phone Number: 86-530-7150111 Fax number: 86-530-7150111 Date of Preparation: Jul.26, 2021 Email: [e-mail]

#### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

#### 2.0 Device information

Trade name: Disposable Surgical Face Mask Common name: Surgical mask Classification name: Mask, Surgical Model(s): ZS-S, tie-on.

#### 3.0 Classification

Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel

#### 4.0 Predicate device information

Manufacturer: Xiantao Rayxin Medical Products Co., Ltd. Device: Disposable Surgical Face Mask 510(k) number: K153496

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#### 5.0 Indication for Use Statement

The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.

### 6.0 Device description

The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with tie on and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. During use, the tie on shall be tied over user head. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.

| Item | Specification(cm) | Tolerance(cm) |
|------------------------|-------------------|---------------|
| Length (L) x Width (H) | 17.5cm×9.5cm | ±5% |
| | 17.5cm×9.0cm | |
| | 17.0cm×9.0cm | |
| | 14.5cm×9.5cm | |
| Nose Piece Length | 10.5cm×0.3cm | ±5% |
| Ties | 40cm×1.0cm | ±5% |

The specification of the device as follows:

# 7.0 Technological Characteristic Comparison Table

| Table 1 - General Comparison | | | | |
|------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Item | Proposed device | Predicated device | Remark | |
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| Product name | Disposable Surgical Face Mask | Disposable Surgical Face Mask | - | |
| 510(k) No. | K210409 | K153496 | - | |
| Models | ZS-S, Tie-on. | Tie on, ear-loop, Flat Pleated, 3 layers | - | |
| Specification | 17.5cm×9.5cm | 17.5cm×9.5cm | - | |
| | 17.5cm×9.0cm | | | |
| | 17.0cm×9.0cm | | | |
| | 14.5cm×9.5cm | | | |
| Intended Use | The Disposable Surgical | The Surgical Face Masks | Same | |
| | | | | |
| | | Face Mask is intended to be<br>worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material. It is<br>intended for use in infection<br>control practices to reduce<br>the potential exposure to<br>blood and body fluids. This is<br>a single use, disposable<br>device(s), provided non<br>sterile. | are intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices to<br>reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non-sterile. | |
| | OTC use | Yes | Yes | Same |
| | Composite | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Same |
| | Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle layer | Melt blown polypropylene | Melt blown polypropylene | Same |
| Mat<br>erial | External layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose piece | Malleable polyethylene<br>wire | Malleable polyethylene<br>wire | Same |
| | Tie-on | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Color | Blue | Blue | Same |
| | Dimension (Length) | 17.5cm×9.5cm, ±5% | 17.5cm×9.5cm, ±1cm | * Gap 1 |
| | | 17.5cm×9.0cm, ±5% | | |
| | | 17.0cm×9.0cm, ±5% | | |
| | | 14.5cm×9.5cm, ±5% | | |
| | Sterility | Non-Sterile | Non-Sterile | Same |
| | Single Use | Yes | Yes | Same |
| | Sterile | No | No | Same |
| | ASTM F2100 Level | Level 3 | Level 2 | * Gap 2 |
| | Shelf life | 2 years | No shelf life claimed | * Gap 3 |
| | Biocompatibility | | | |
| Cytotoxicity | | Under the conditions of the<br>study, the subject device was<br>non-cytotoxic | Under the conditions of the<br>study, the predicate device<br>was non-cytotoxic | Same |
| Irritation | | Under the conditions of the<br>study, the subject device was<br>non-irritating | Under the conditions of the<br>study, the predicate device<br>was non-irritating | Same |
| | Sensitization | Under the conditions of the<br>study, the subject device was<br>non-sensitization | Under the conditions of the<br>study, the predicate device<br>was non-sensitization | Same |

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* Gap analysis:

Gap 1: the proposed device has 4 specifications, with lower dimension tolerance than the predicate device, the different specifications does not impact the surgical mask

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performance and safety, considering the stricter tolerance of proposed device, the difference does not bring additional risks to the device.

Gap 2: the proposed device has higher performance level (Level 3) higher than the predicate device, the higher performance does not bring additional risks to the device. Gap 3: the predicate device does not claim specific shelf life while the proposed device define its 2 years shelf life which is proved by its shelf life performance study, the clear shelf life does not bring additional risks to the product use.

#### 8.0 Summary of Non-Clinical Testing

The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.

| Items | Performance | Acceptance Criteria<br>(Level 3, ASTM<br>F2100-19) | Result |
|-------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------|--------|
| Bacterial filtration<br>efficiency (BFE) (%) | >98% | ≥98 | Pass |
| Different pressure<br>(mmH2O/cm²) | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
| Sub-micron particulate<br>filtration efficiency at 0.1<br>micron, % (PFE) | >98% | ≥98 | Pass |
| Resistance to penetration<br>by synthetic blood,<br>Minimum pressure in<br>mmHg for pass result | 31 of 32 test articles<br>passed at 160mmHg | 29 of 32 test articles<br>passed at 160mmHg | Pass |
| Flame spread | Class 1 | Class 1 | Pass |

#### Table 3 - Biocompatibility Testing

| Item | Proposed Device | Result |
|---------------|------------------------------------------------------------------|--------|
| Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device is nonsensitizing. | Pass |

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: 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

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devices— Part 10: Tests for irritation and skin sensitization.

# 9.0 Clinical Test Conclusion

No clinical study implemented for the Disposable Surgical Face Mask.

#### 10.0 Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210409, the Disposable Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153496.