← Product Code [FXX](/productcode/FXX) · K212610
# Surgical Face Mask (K212610)
_Foshan Nanhai Plus Medical Co, Ltd. · FXX · Jan 26, 2022 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K212610
## Device Facts
- **Applicant:** Foshan Nanhai Plus Medical Co, Ltd.
- **Product Code:** [FXX](/productcode/FXX.md)
- **Decision Date:** Jan 26, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Indications for Use
The Surgical face 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, provided non-sterile.
## Device Story
Surgical face mask; flat-pleated, three-layer sandwich structure; inner/outer layers polypropylene nonwoven; middle layer polypropylene melt-blown nonwoven; nosepiece galvanized iron wire with PE coating; attachment via spandex elastic ear loops or polypropylene nonwoven tie straps. Device acts as self-inhalation filter mask; filters air containing harmful substances before inhalation/exhalation. Used in clinical settings for infection control; worn by healthcare personnel and patients. Provides barrier protection against microorganisms, body fluids, and particulate aerosols. Single-use, disposable, non-sterile.
## Clinical Evidence
No clinical data. Bench testing only. Performance testing included Bacterial Filtration Efficiency (BFE), sub-micron particle filtration efficiency, differential pressure, flammability (Class 1), and synthetic blood penetration resistance (120 mmHg for Level 2; 160 mmHg for Level 3). Biocompatibility testing included cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), skin irritation (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). Simulated transportation testing per ASTM D4169 passed.
## Technological Characteristics
Three-layer polypropylene nonwoven construction; middle layer polypropylene melt-blown nonwoven. Nosepiece: galvanized iron wire with PE coating. Attachments: spandex elastic (ear loops) or polypropylene nonwoven (tie straps). ASTM F2100-19 Level 2 and Level 3 performance. Non-sterile. Latex-free. Dimensions: 17.5 cm x 9.5 cm.
## Regulatory 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 Masks (Ear loops and Tie-on) ([K160269](/device/K160269.md))
## Submission Summary (Full Text)
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January 26, 2022
Foshan Nanhai Plus Medical CO LTD % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K212610
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 21, 2021 Received: December 27, 2021
Dear Olivia Meng:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Clarence W. Murray, III, Ph.D. 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) K212610
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical face 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, provided non-sterile.
Level 2 Surgical Face Mask Models: Tie strap type: 522-001, 522-003, 522-005 Ear loop type: 522-002, 522-004, 522-006 Level 3 Surgical Face Mask Models: Tie strap type: 533-001, 533-003, 533-005 Ear loop type: 533-002, 533-004, 533-006
| 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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Image /page/3/Picture/0 description: The image shows the logo for Plus Medical. The logo features the letters "PM" in a bold, sans-serif font, with the letters stacked on top of each other. A red swoosh runs horizontally through the letters. Below the letters, the words "PLUS MEDICAL" are written in a smaller, sans-serif font.
# K212610
# 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
### 1. SUBMITTER
Foshan Nanhai Plus Medical CO LTD Shijiang Industrial Zone, Shatou, Jiujiang Town, Nanhai, Foshan City, Guangdong, China Phone: +86-757-86914198 Fax: +86-755-27343466
| Primary Contact Person: | Olivia Meng
Regulatory Affairs Manager
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Tel: (+86)-20-6231 6262
Fax: (+86)-20-8633 0253 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact Person: | Suyi Li
Regulatory Affairs Manager
Foshan Nanhai Plus Medical CO LTD
Phone: +86-757-86914198
Fax: +86-755-27343466 |
| Date prepared | Dec 19th , 2021 |
| 2. DEVICE | |
| Device Name: | Surgical face mask |
| Common name: | Mask, Surgical |
| Model: | 522-001, 522-002, 522-003, 522-004, 522-005, 522-006, 533-001, 533-002, 533-003, 533-004, 533-005, 533-006 |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | 2 |
| Product Code: | FXX |
### 3. PREDICATE DEVICE
K160269, Surgical Face Masks (Ear loops and Tie-on) This predicate has not been subject to a design-related recall.
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Image /page/4/Picture/0 description: The image shows the logo for Plus Medical. The logo features the letters 'PM' in a bold, sans-serif font, with the letters colored in a bright blue. A red swoosh or curved line runs horizontally through the middle of the letters, adding a dynamic element to the design. Below the letters, the words 'PLUS MEDICAL' are written in a smaller, sans-serif font, also in blue.
#### 4. DEVICE DESCRIPTION
The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use.
The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free.
lt is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
| Model# | Ear Type | ASTM F2100 Level |
|---------|-----------|------------------|
| 522-001 | Tie strap | |
| 522-002 | Ear loop | Level 2 |
| 522-003 | Tie strap | |
| 522-004 | Ear loop | |
| 522-005 | Tie strap | |
| 522-006 | Ear loop | |
| 533-001 | Tie strap | |
| 533-002 | Ear loop | Level 3 |
| 533-003 | Tie strap | |
| 533-004 | Ear loop | |
| 533-005 | Tie strap | |
| 533-006 | Ear loop | |
Twelve models are included in this submission, the differences listed below:
Six models including 522-001, 522-002, 522-004, 522-005, 522-005, 522-006 are level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- Bacterial filtration efficiency (BFE) ≥98%
- Sub-micron particle filtration efficiency ≥98%
- Different pressure: <6.0 mm H2O/cm2
- Flammability: class 1
- Resistance to penetration by synthetic blood: 120 mmHg
Six models including 533-001, 533-002, 533-003, 533-005, 533-006 are level 3 according to ASTM F2100-19. The main parameters of the product are listed as followed:
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Image /page/5/Picture/0 description: The image shows the logo for Plus Medical. The logo features the letters "PM" in a bold, blue font, with a red swoosh underlining the letters. Below the letters, the words "PLUS MEDICAL" are written in a smaller, black font.
- Bacterial filtration efficiency (BFE) ≥98%
- Sub-micron particle filtration efficiency ≥98%
- Different pressure: <6.0 mm H2O/cm²
- Flammability: class 1
- Resistance to penetration by synthetic blood: 160 mmHg
#### INDICATIONS FOR USE 5.
The Surgical face 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, provided non-sterile.
| Item | Proposed device | Predicate device | Comparison result | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------|
| Manufacturer | Foshan Nanhai Plus Medical CO LTD | San-M Package Co., Ltd. | NA | |
| 510K Number | K212610 | K160269 | NA | |
| Product Common Name | Surgical face mask | Surgical Face Masks (Ear loops and Tie-on) | NA | |
| Intended Use | The Surgical face 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, provided non-sterile. | The surgical face 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, provided non-sterile. | Same | |
| Mask style | Flat pleated | Flat pleated | Same | |
| Design feature | Ear loop, tie strap
Colors: white or blue
No visor option | Ear loop, tie-on
Colors: white or blue
Visor option: polyester | Similar | |
| Material of outer facing layer | Polypropylene nonwoven | Polypropylene | Same | |
| Material of middle layer | Polypropylene meltblown nonwoven | Polypropylene meltblown and polypropylene spunbond | Similar | |
| Material of inner facing layer | Polypropylene nonwoven | Polypropylene | Same | |
| Nosepiece | Galvanized iron wire wrapped with polyethylene(PE) | Polypropylene coated steel wire | Similar | |
| Attachment | Ear loops: Spandex elastic
Tie strap: Polypropylene
nonwoven | Ear loops: Polyester, polyurethane
Side tapes: Polyester spunbond
(ear loops mask only)
Tie tapes: Polypropylene
spunbond or polyester spunbond | Similar | |
| Dimension
(Length × Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm
18.0 cm × 9.0 cm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Single use | Yes | Yes | Same | |
| ASTM F 2100
level | Level 2
Level 3 | Level 1
Level 2
Level 3 | Similar | |
| Flammability | For 3 non-consecutive lots,
32 out of 32 pass.
Level 2: Class 1
Level 3: Class 1 | Level 1: Class 1
Level 2: Class 1
Level 3: Class 1 | Similar | |
| Bacterial
Filtration
Efficiency | For 3 non-consecutive lots,
32 out of 32 pass.
Level 2: average at 99.66%
Level 3: average at 99.58% | Level 1: > 98%
Level 2: > 98%
Level 3: > 99% | Similar | |
| Differential
Pressure | For 3 non-consecutive lots,
32 out of 32 pass.
Level 2: 4.4 mm $H_2O/cm^2$
Level 3: 5.06 mm $H_2O/cm^2$ | Level 1: pass at 2.0 mm $H_2O/cm^2$
Level 2: pass at 1.6 mm $H_2O/cm^2$
Level 3: pass at 2.5 mm $H_2O/cm^2$ | Similar | |
| Sub-Micron
Particle Filtration
Efficiency | For 3 non-consecutive lots,
32 out of 32 pass.
Level 2: average at 99.54%
Level 3: average at 99.67% | Level 1: 99.6%
Level 2: 99.6%
Level 3: 99.7% | Similar | |
| Resistance to
Penetration by
Synthetic Blood | For 3 non-consecutive lots,
≥29 out of 32 pass
(which met the requirements).
Level 2: at 120 mmHg
Level 3: at 160 mmHg | Level 1: pass at 80 mmHg
Level 2: pass at 120 mmHg
Level 3: pass at 160 mmHg | Similar | |
| Biocompatibility | | | | |
| Cytotoxicity | Under the conditions of the
study, show potential cytotoxicity. | Under the conditions of the study,
not cytotoxic. | Different | |
| Irritation | Under the conditions of the
study, not an irritant. | Under the conditions of the study,
not an irritant. | Same | |
| Sensitization | Under conditions of the study,
not a sensitizer. | Under conditions of the study, not
a sensitizer. | Same | |
| Acute systemic
toxicity | Under the conditions of the
study, no systemic toxicity from
the device. | -- | Similar | |
| Test item | Test purpose | Acceptance criteria | Results | |
| Performance
test | Flammability | Testing the characteristics of a
material that pertain to its relat
ive ease of ignition and relative
ability to sustain combustion. | Class 1
ASTM F2100 | Pass |
| | Bacterial Filtration
Efficiency | Testing the effectiveness of
medical face mask material in
preventing the passage of
aerosolized bacteria. | Level 2: ≥ 98%
ASTM F2100 | Pass |
| | Different Pressure,
mm H2O/cm² | Measuring the pressure of
dropping across a medical face
mask material. | Level 2: < 6.0
ASTM F2100 | Pass |
| | Sub-Micron
Particle Filtration
Efficiency | Testing the efficiency of the
filter material in capturing
aerosolized particles smaller
than one micron. | Level 2: ≥ 98%
ASTM F2100 | Pass |
| | Resistance to
Penetration by
synthetic blood | Testing the efficiency of
resistance to penetration by
synthetic blood. | Level 2: pass at
120 mmHg
ASTM F2100 | Pass |
| Biocompatibi
lity | Cytotoxicity | Determining the cytotoxicity of
proposed device. | Grade ≤ 2
ISO 10993-5 | Fail |
| | Sensitization | Determining whether the
proposed device has
sensitization potential. | Sensitization
classification grade < 3
ISO 10993-10 | Pass |
| | Skin Irritation | Determining whether the
proposed device has irritation
potential. | Reaction score is 1,0 or
less
ISO 10993-10 | Pass |
| | Acute systemic
toxicity | Determining whether the
proposed device has systemic
toxicity potential. | Less than 2 animals
appear clinical
abnormal and body
weight loss ≤ 10%
ISO 10993-11 | Pass |
| Test item | | Test purpose | Acceptance criteria | Results |
| Performance
test | Flammability | Testing the characteristics of a
material that pertain to its relati
ve ease of ignition and relative a
bility to sustain combustion. | Class 1
ASTM F2100 | Pass |
| | Bacterial Filtration
Efficiency | Testing the effectiveness of
medical face mask material in
preventing the passage of
aerosolized bacteria. | Level 3: ≥ 98%
ASTM F2100 | Pass |
| | Different Pressure,
mm H2O/cm² | Measuring the pressure of
dropping across a medical face
mask material. | Level 3: < 6.0
ASTM F2100 | Pass |
| | Sub-Micron
Particle Filtration
Efficiency | Testing the efficiency of the
filter material in capturing
aerosolized particles smaller
than one micron. | Level 3: ≥ 98%
ASTM F2100 | Pass |
| | Resistance to
Penetration by
synthetic blood | Testing the efficiency of
resistance to penetration by
synthetic blood. | Level 3: pass at
160 mmHg
ASTM F2100 | Pass |
| Biocompatibi
lity | Cytotoxicity | Determining the cytotoxicity of
proposed device. | Grade ≤ 2
ISO 10993-5 | Fail |
| | Sensitization | Determining whether the
proposed device has
sensitization potential. | Sensitization
classification grade < 3
ISO 10993-10 | Pass |
| | Skin Irritation | Determining whether the
proposed device has irritation
potential. | Reaction score is 1,0 or
less
ISO 10993-10 | Pass |
| | Acute systemic
toxicity | Determining whether the
proposed device has systemic
toxicity potential. | Less than 2 animals
appear clinical
abnormal and body
weight loss ≤ 10%
ISO 10993-11 | Pass |
| Simulated transportation | | Determining the ability of
shipping units to withstand the
distribution environment. | No damage on
packaging and
products after DC 13
procedure of ASTM
D4169 | Pass |
### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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Image /page/6/Picture/0 description: The image contains a logo for Plus Medical. The logo features the letters "PM" in a bold, blue font, with a red swoosh underlining the letters. Below the letters, the words "PLUS MEDICAL" are written in a smaller, sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for Plus Medical. The logo features the letters 'PM' in a bold, blue font, with a red swoosh underlining the letters. Below the letters, the words 'PLUS MEDICAL' are written in a smaller, black font.
The differences between the Surgical face mask and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Surgical face mask should perform as intended in the specified use conditions.
## 7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
### Level 2 product:
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Image /page/8/Picture/0 description: The image shows a logo for Plus Medical. The logo features the letters 'PM' in a bold, blue font, with a red swoosh-like shape running horizontally through the letters. Below the letters, the words 'PLUS MEDICAL' are written in a smaller, black font.
### Level 3 product:
### 8. SUMMARY of CLINICAL TESTING
Clinical testing is not applicable to the subject device.
### 9. CONCLUSION
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
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**Source:** [https://fda-staging.innolitics.com/device/K212610](https://fda-staging.innolitics.com/device/K212610)
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