Procedure Mask, Surgical Mask

K202899 · Kenpax International Limited · FXX · May 20, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202899
• Device Name: Procedure Mask, Surgical Mask
• Applicant: Kenpax International Limited
• Product Code: FXX · General, Plastic Surgery
• Decision Date: May 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare 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

Single-use, three-layer, flat-folded face masks; available as ear-loop (procedure) or tie-on (surgical) styles. Construction: outer/inner layers of spunbond polypropylene; middle layer of meltblown polypropylene filter; polyethylene-coated steel nose wire. Used in clinical settings for infection control; worn by healthcare personnel and patients. Provides physical barrier against microorganisms, body fluids, and particulates. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100, ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration), ASTM F2101 (bacterial filtration), EN 14683 (differential pressure), and 16 CFR 1610 (flammability). Biocompatibility tested per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Three-layer construction: spunbond polypropylene (outer/inner), meltblown polypropylene (filter). Nose wire: polyethylene-coated steel. Ear loops: nylon/spandex or polyester. Tie-on: spunbond polypropylene. Flat-pleated design. Non-sterile. ASTM F2100 Level 1 and Level 3 performance specifications.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material; intended for infection control to reduce exposure to blood and body fluids. Single-use, disposable, non-sterile.

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, Ear Loops, Model 101B, 101G, 136B, 136G, 137B, 137G Surgical Face Mask, Tie-on, Model 145B, 145G, 143B, 138G, 138G, 142B, 142G, 151B, 151G (K133070)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized image of a bird or eagle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2021

Kenpax International Limited % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K202899

Trade/Device Name: Procedure Mask/Surgical Mask (Ear loops and Tie-on) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 8, 2021 Received: February 11, 2021

Dear Ivy 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 W. Murray III, Ph.D. 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) K202899

Device Name Procedure Mask/ Surgical Mask Ear loops and Tie-on

#### Indications for Use (Describe)

The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### KENPAX INTERNATIONAL LIMITED Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China

## 510(K) Summary K202899

Date of summary prepared: 2021-05-20

#### A. Applicant:

KENPAX INTERNATIONAL LIMITED Address: Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

US agent: Solomon Chen 17947 PASEO DEL SOL Chino Hills, CA, US 91709 Phone: [phone] Ext Email: [e-mail]

#### B. Device:

Trade Name: Procedure mask/ Surgical Mask Common Name: SURGICAL MASK Model: ear loops & Tie-on

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

### C. Predicate device:

# K133070 Surgical Face Mask, Ear Loops, Model 101B, 101G, 136B, 136G, 137B, 137G Surgical Face Mask, Tie-on, Model 145B, 145G, 143B, 138G, 138G, 142B, 142G, 151B, 151G BH Medical Products Co., Ltd.

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#### KENPAX INTERNATIONAL LIMITED Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China

### D. Indications for use of the device:

The Procedure Masks/ 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.

#### E. Device Description:

The Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter.

The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green.

The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter.

The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue.

The procedure masks are sold non-sterile and are intended to be single use, disposable device. The difference

| Product Model | Feature | Layers (components) | Nose Wire | Earloop | Colorant |
|---------------------------|------------------|---------------------|-----------------------------------|-----------|--------------------------------|
| 68-8506-G<br>ASTM Level 1 | Green<br>Earloop | Outer: 22gsm SPP | Polyethylene<br>Coated Steel Wire | Polyester | Green<br>masterbatch<br>PCG861 |
| | | Middle: 22gsm MB | | | |
| | | Inner: 22gsm SPP | | | |
| 68-8508-G<br>ASTM Level 3 | Green<br>Earloop | Outer: 25gsm SPP | Polyethylene<br>Coated Steel Wire | Polyester | Green<br>masterbatch<br>PCG861 |
| | | Middle: 25gsm MB | | | |
| | | Inner: 25gsm SPP | | | |
| 68-8536-B<br>ASTM Level 1 | Blue<br>Tie-on | Outer: 22gsmSPP | Polyethylene<br>Coated Steel Wire | 40gsm SPP | Blue<br>masterbatch<br>PCB1628 |
| | | Middle: 22gsmMB | | | |
| | | Inner: 22gsmSPP | | | |
| 68-8538-B<br>ASTM Level 3 | Blue<br>Tie-on | Outer: 25gsmSPP | Polyethylene<br>Coated Steel Wire | 40gsm SPP | Blue<br>masterbatch<br>PCB1628 |
| | | Middle: 25gsmMB | | | |
| | | Inner: 25gsmSPP | | | |

#### Detailed information of the four models please see below table.

#### F. Comparison with predicate device

The procedure masks/surgical masks are essentially the same as or similar to the predicate device in terms of the intended use, design and construction, performance characteristics.

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#

| Table 1 General Comparison | | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Device | Proposed Device | Predicate Device | Result |
| 510K # | K202899 | K133070 | |
| Manufacturer | KENPAX INTERNATIONAL LIMITED | BH Medical Products Co., Ltd. | |
| Model<br>Name | Procedure Mask/ Surgical Mask<br>Ear loops & tie-on | Surgical Face Mask, Ear Loops, Model<br>101B, 101G, 136B, 136G, 137B, 137G<br>Surgical Face Mask, Tie-on, Model 145B,<br>145G, 143B, 143G, 138B, 138G, 142B,<br>142G, 151B, 151G | Similar |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend Use/<br>Indications<br>for Use | The Procedure Masks/ Surgical Masks<br>are intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. These face masks<br>are intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and body<br>fluids. This is a single use, disposable<br>device(s), provided non-sterile. | The surgical face masks are intended to<br>be worn to protect both the patient<br>and healthcare personnel from transfer<br>of microorganisms, body fluids and<br>particulate material. These face masks<br>are intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and body<br>fluids. This is a single use, disposable<br>device(s), provided non-sterile. | Same |
| Materials | | | |
| Outer layer | Spunbond Polypropylene<br>Level 1: 22gsm<br>Level 3: 25gsm | Spunbond Polypropylene | Same |
| Inner layer | Spunbond Polypropylene<br>Level 1: 22gsm<br>Level 3: 25gsm | Spunbond Polypropylene | Same |
| Filter layer | Melt-blown Polypropylene<br>Level 1: 22gsm<br>Level 3: 25gsm | Meltblown Polypropylene | Same |
| Nose wire | Polyethylene Coated Steel Wire | Aluminum Wire | Different |
| Ear loops | Nylon, spandex | Polyester | Different |
| Tie-on | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Design<br>Features | Ear Loops, Tie-on | Ear Loops, Tie-On | Same |
| Mask style | Flat Pleated | Flat Pleated | Same |
| Color | Blue, green | Blue, Green | Same |
| Dimension<br>(Length) | 178±5mm | 3.5"+/-0.25"<br>4.2"+/-0.25" | Similar |
| Dimension<br>(Width) | 95±5mm | 6.8"+/-0.25" | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Biocompatibility | Non-cytotoxic, Non-sensitizing, non-irritating | Non-cytotoxic, Non-sensitizing, non-irritating | Same |
| Performance Testing (see Table 2) | | | |
| ASTM level | Level 1, Level 3 | Level 1, Level 2, Level 3 | Similar |
| Fluid<br>Resistance | Meet ASTM F1862-17 | Meet ASTM F1862-07 | similar |
| Particulate<br>Filtration<br>Efficiency | Meet ASTM F2299-17 | Meet ASTM F2299-03 | Similar |
| Bacterial<br>Filtration<br>Efficiency | Meet ASTM F2101-19 | Meet ASTM F2101-07 | Similar |
| Differential<br>Pressure | Meet EN 14683: 2019, Annex C | Meet MIL-M36945C | Different |
| Flammability | Meet 16 CFR 1610 | Meet 16 CFR 1610 | Similar |
| Biocompatibility | Non-cytotoxic, Non-sensitizing, non-irritating | Non-cytotoxic, Non-sensitizing, non-irritating | Same |

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# KENPAX INTERNATIONAL LIMITERNATIONAL LIMITED
Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China

### Table 2 Comparison of Performance testing

| Item | Proposed device (K202899) | | Predicate device (K133070) | Acceptance criteria (Level 1) | Result |
|-----------------------------------|----------------------------------------|----------------------------------------|-------------------------------------------------------------|-------------------------------|--------|
| | Model 68-8506-G | Model 68-8536-B | | | |
| Fluid Resistance | 32 out of 32 passed at 80 mmHg, 3 lots | 32 out of 32 passed at 80 mmHg, 3 lots | Meet the ASTM F2100 Requirements for Level 1 Classification | 29 out of 32 pass at 80 mmHg | PASS |
| Particulate Filtration Efficiency | 97.4%, 97.5%, 97.5% | 97.2%, 97.1%, 97.1% | Meet the ASTM F2100 Requirements for Level 1 Classification | ≥95% | PASS |
| Bacterial Filtration Efficiency | 99.9% 3 lots | 99.9% 3 lots | Meet the ASTM F2100 Requirements for Level 1 Classification | ≥95% | PASS |
| Differential Pressure | 2.9, 2.8, 2.7 mmH₂O/cm² | 3.7, 3.4, 3.7 mmH₂O/cm² | Meet the ASTM F2100 Requirements for Level 1 Classification | <5.0 | PASS |
| Flammability | Class 1 | Class 1 | Class 1 | Class 1 | PASS |

| Item | Proposed device (K202899) | | Predicate device<br>(K133070) | Acceptance criteria<br>(Level 3) | Result |
|------|---------------------------|-----------------|-------------------------------|----------------------------------|--------|
| | Model 68-8508-G | Model 68-8538-B | | | |

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KENPAX INTERNATIONAL LIMITED Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China

| Fluid<br>Resistance | 32 out of 32 passed<br>at 160 mmHg, 3 lots | 32 out of 32 passed<br>at 160 mmHg, 3 lots | Meet the ASTM F2100<br>Requirements for<br>Level 3 Classification | 29 out of 32 pass<br>at 160 mmHg | PASS |
|-----------------------------------------|--------------------------------------------|--------------------------------------------|-------------------------------------------------------------------|----------------------------------|------|
| Particulate<br>Filtration<br>Efficiency | 98.2%,<br>98.4%<br>98.4% | 98.4%,<br>98.4%,<br>98.3% | Meet the ASTM F2100<br>Requirements for Level<br>3 Classification | ≥98% | PASS |
| Bacterial<br>Filtration<br>Efficiency | 99.9%, 3 lots | 99.9%, 3 lots | Meet the ASTM F2100<br>Requirements for Level<br>3 Classification | ≥98% | PASS |
| Differential<br>Pressure | 3.4, 3.0, 3.0<br>mmH2O/cm² | 4.1, 3.4, 3.4<br>mmH2O/cm² | Meet the ASTM F2100<br>Requirements for Level<br>3 Classification | <6.0 | PASS |
| Flammability | Class 1 | Class 1 | Class 1 | Class 1 | PASS |

#### G. Summary of Non-Clinical Test

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with 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:

- > ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- > ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- > ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A EN 14683, Medical Face Masks—Requirements and Test Methods;
- > ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- > ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;

#### H. Summary of Clinical Test

No clinical study is included in this submission.

#### l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K133070.