Savewo ClassicMASK

K221957 · Savewo Limited · FXX · Sep 2, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221957
• Device Name: Savewo ClassicMASK
• Applicant: Savewo Limited
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. Savewo ClassicMASKs 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) and provided non-sterile.

Device Story

Savewo ClassicMASK is a 3-layered, flat-pleated, single-use, disposable surgical face mask. It consists of an outer spunbond polypropylene layer, a middle melt-blown polypropylene filtration layer, and an inner hydrophilic polypropylene/polyethylene non-woven layer. The device features ear loops and a metal nose strip to secure the mask over the user's mouth and face. It is intended for use in clinical settings by healthcare personnel or patients to provide a physical barrier against microorganisms, body fluids, and particulates. The mask is provided non-sterile and meets ASTM F2100-19 Level 3 performance specifications. It functions as a passive barrier; no active components, software, or algorithms are involved.

Clinical Evidence

Bench testing only. Performance verified against ASTM F2100-19 Level 3 requirements: BFE (≥99.9%), PFE (≥99.6% at 0.1 micron), differential pressure (<4.19 mmH2O/cm²), synthetic blood penetration resistance (160 mmHg), and flammability (Class 1). Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed the device is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

3-layer construction: outer spunbond polypropylene, middle melt-blown polypropylene, inner 50% polypropylene/50% polyethylene hydrophilic non-woven. Features: metal nose strip (75% polypropylene/25% iron), ear loops (80% polyamide/20% spandex). Dimensions: 175x95 mm. Performance: ASTM F2100-19 Level 3. Non-sterile.

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

• Single-use Surgical Mask (K200923)

Submission Summary (Full Text)

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September 2, 2022

Savewo Limited % Ivy Lai Regulatory Manager Long Jing Technology Ltd. 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong 0000 China

Re: K221957

Trade/Device Name: Savewo ClassicMASK Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 1, 2022 Received: July 5, 2022

Dear Ivy Lai:

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 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) K221957

Device Name Savewo ClassicMASK

Indications for Use (Describe)

Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Savewo ClassicMASKs 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) and 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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510(k) Submission

# 510(k) Summary

### 1 Date Prepared

06/30/2022

### 2 Submitter's Information

Name of Sponsor: Savewo Limited Address: 1/F & 2/F, 266-270 Texaco Road, Tsuen Wan, Hong Kong Contact Name: Melanie Choi Telephone No.: [phone] E-mail: [e-mail]

### 3 Trade Name, Common Name, Classification

Trade/Device Name: Savewo ClassicMASK Common Name: Surgical face mask Classification Name: Surgical apparel Review Panel: General and Plastic Surgery Product Code: FXX Device Classification: 2

- Identification of Predicate Device(s) 4 Predicate Device: Single-use Surgical Mask (K200923)
### 5 Description of the Device

Savewo ClassicMASK is a 3-layered mask. The outer layer is made of spunbond polypropylene with white color, the inner layer is made of hydrophilic polypropylene/polyethylene non-woven fabric, and the middle layer with filtration function is made of melt-blown polypropylene. The

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mask contains ear loops to secure the mask over the users' mouth and face and the metal nose strip over the top edge which secures the mask to stay firmly in place. Savewo ClassicMASK is single use, disposable, non-sterile and ASTM Level 3 certified.

### 6 Indication

Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Savewo ClassicMASKs 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) and provided non-sterile.

### 7 Comparison to the Predicate Device

Savewo ClassicMASK, the subject of this application, is compared with the predicate Device, Single-use Surgical Mask (K200923), in terms of indication, mechanism, design features, structure/material, and performance. The subject device and predicate devices claim Level 3 in accordance with ASTM F2100-19 standard.

The results are shown below in the Technological Characteristics Comparison Table:

| | Subject Device | Predicate Device | Comparison |
|--------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------|
| Manufacturer | Savewo Limited | BYD Precision<br>Manufacturer Co.Ltd. | |
| Trade Name | Savewo ClassicMASK | Single-use Surgical Mask | |
| 510(k) number | N/A | K200923 | -- |
| Device Class | 2 | 2 | Same |
| Product Code | FXX | FXX | Same |
| Device classification<br>Name | Surgical apparel | Surgical apparel | Same |
| Regulation number | 878.4040 | 878.4040 | Same |
| Intended Use/<br>Indications for Use | Savewo ClassicMASKs are<br>intended to be worn to<br>protect both patient and | The Single-use Surgical<br>Masks (Model: FE2311)<br>are intended to be worn | Same |

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# 510(k) Submission

| healthcare personnel from<br>transfer of<br>microorganisms, body<br>fluids, and particulate<br>material.<br>Savewo ClassicMASKs are<br>intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and<br>body fluids.<br>This is a single use,<br>disposable device(s) and<br>provided non-sterile. | | | | to protect both<br>thepatient and<br>healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids and<br>particulatematerial.<br>These face masks are<br>intended for use in<br>infection control<br>practices to reduce<br>thepotential exposure<br>to blood and body<br>fluids.<br>This is a single use,<br>disposable device(s),<br>provided non-sterile. | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Materials | | | | | | | |
| Outer cover web | Spunbond Polypropylene | Spunbond polypropylene | Same | | | | |
| Middle web | Melt-Blown Polypropylene | Melt-blown<br>polypropylene filter | Same | | | | |
| Inner cover web | 50% polypropylene + 50%<br>polyethylene Hydrophilic<br>non-woven fabric | Spunbond polypropylene | Different*¹ | | | | |
| Nose wire | 75% polypropylene + 25%<br>iron nose-strip | Metal Core Plastic | Different*1 | | | | |
| Ear loop | 80% polyamide + 20%<br>spandex ear-loop | Polyester | Different*1 | | | | |
| Design Features | | | | | | | |
| Colors | White | Blue | Different*2 | | | | |
| Style | Flat-pleated | Flat Pleated | Same | | | | |
| Multiple layers | 3 layers | 3 layers | Same | | | | |
| Single use | Yes | Yes | Same | | | | |
| Dimensions | 175x95 mm | 175x95 mm | Same | | | | |
| Sterility | | | | | | | |
| Sterile | Non-Sterile | Non-Sterile | Same | | | | |
| Biocompatibility | | | | | | | |
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Same | | | | |
| Sensitization/irritation | Non-sensitizing, Non-<br>irritating | Non-sensitizing, Non-<br>irritating | Same | | | | |
| Product barrier specification ASTM F2100 - Meets ASTM Level 3 | | | | | | | |
| Bacterial filtration<br>efficiency (BFE) (%)<br>ASTM F2101 | Passed at ≥98% | Passed at ≥98% | Same | | | | |
| Particulate filtration<br>efficiency (PFE) (%)<br>ASTM F2299 | Pass at ≥98% @ 0.1<br>micron | Pass at ≥98% @ 0.1<br>micron | Same | | | | |
| Differential pressure<br>(mmH2O/cm²)<br>MIL-M36954C | Passed at <6 mmH2O/cm² | Passed at <6 mmH2O/cm² | Same | | | | |
| Resistance to<br>penetration by<br>synthetic blood<br>(mmHg) | Passed at 160mm Hg | Passed at 160mm Hg | Same | | | | |

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## Savewo Limited Savewo ClassicMASK

510(k) Submission

| ASTM F1862 | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|------|
| Flammability<br>CFR 16 1610 | Class 1 | Class 1 | Same |
| *1: The differences in the materials of inner layer, nose wire and ear loop do not raise additional<br>questions for safety and effectiveness. Biocompatibility evaluation has been performed on the finished<br>device which includes all construction materials. Besides, the subject device conforms with ASTM F2100<br>standard and meets level 3 performance specifications. | | | |
| *2: The difference in the color does not raise additional questions for safety and effectiveness because<br>they are only used in the outer layer of the mask. Biocompatibility evaluation has been performed on<br>the finished device which includes all construction materials. | | | |

The Savewo ClassicMASK has same indications, same mechanism, similar materials, similar product design, same performance as the predicate devices. The Savewo ClassicMASK is substantially equivalent to the Singleuse Surgical Mask (K200923) as these products conform with ASTM F2100 standard and meet Level 3 performance specifications. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device.

### Non-Clinical Testing Summary 8

The proposed device was tested and conformed to the following 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.

| Item | Test Mothd/ Standard | Acceptance Criteria | Results |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------|---------|
| Cytotoxicity | ISO 10993-5:2009 - Biological<br>Evaluation of Medical Devices --<br>Part 5: Tests for in Vitro<br>Cytotoxicity | Non-Cytotoxic | Pass |
| Sensitization | ISO 10993-10:2010 - Biological<br>Evaluation of Medical Devices --<br>Part 10: Tests for Irritation and Skin<br>Sensitization | Non-sensitizing | Pass |
| Irritation | ISO 10993-10:2010 - Biological<br>Evaluation of Medical Devices --<br>Part 10: Tests for Irritation and Skin<br>Sensitization | Non-irritating | Pass |

#### Biocompatibility a)

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# 510(k) Submission

| Item | Test Method/ Standard | Acceptance<br>Criteria | Results |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bacterial<br>filtration<br>efficiency<br>(BFE) (%) | ASTM F2101-19 - Standard<br>Test Method for Evaluating<br>the Bacterial Filtration<br>Efficiency (BFE) of Medical<br>Face Mask Materials, Using<br>a Biological Aerosol of<br>Staphylococcus aureus | Passed at ≥<br>98% | 3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot 1: ≥99.9%<br>Lot 2: ≥99.9%<br>Lot 3: ≥99.9% |
| Particulate<br>filtration<br>efficiency<br>(PFE) (%) | ASTM F2299/F2299M-03 -<br>Standard Test Method for<br>Determining the Ini-tial<br>Efficiency of Materials<br>Used in Medical Face<br>Masks to Penetration by<br>Particulates Using Latex<br>Spheres | Pass at ≥98% | 3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot 1: ≥99.6%<br>Lot 2: ≥99.7%<br>Lot 3: ≥99.7% |
| Differential<br>pressure<br>(mmH2O/cm²) | MIL-M-36945C, Military<br>Specifications: Surgical<br>Mask, disposable | Passed at <6<br>mmH2O/cm² | 3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot 1: <4.11 mmH2O/cm²<br>Lot 2: <4.19 mmH2O/cm²<br>Lot 3: <4.08 mmH2O/cm² |
| Resistance to<br>penetration<br>by synthetic<br>blood<br>(mmHg) | ASTM F1862/F1862M-17 -<br>Standard Test Method for<br>Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood<br>(Horizontal Projection of<br>Fixed Volume at a Known<br>Velocity) | Passed at<br>160mm Hg | 3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot 1: 32 out of 32 Pass at 160<br>mmHg<br>Lot 2: 31 out of 32 Pass at 160<br>mmHg<br>Lot 3: 31 out of 32 Pass at 160<br>mmHg |
| Flammability | 16 CFR Part 1610 -<br>Standard for the<br>Flammability of Clothing<br>Textiles | Class 1 | 3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot 1: Class 1<br>Lot 2: Class 1<br>Lot 3: Class 1 |

### Performance test b)

#### Accelerated aging test a)

- . ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
### Transportation test b)

- . ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems

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### Conclusion 9

The conclusions drawn from the non-clinical tests demonstrate that the Savewo ClassicMASK is as safe, as effective, and performs as well as or better than the legally marketed predicate device Single-use Surgical Mask (K200923).