← Product Code [FXX](/productcode/FXX) · K210815
# Disposable Face Mask (K210815)
_Biobase Scientific (Shandong) Co., Ltd. · FXX · May 13, 2021 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K210815
## Device Facts
- **Applicant:** Biobase Scientific (Shandong) Co., Ltd.
- **Product Code:** [FXX](/productcode/FXX.md)
- **Decision Date:** May 13, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Indications for Use
The Disposable 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
Disposable, three-layer, flat-pleated face mask; features ear loops (spandex/nylon) and malleable nose clip (iron wire/polyethylene). Inner/outer layers: spun-bond polypropylene; middle layer: melt blown polypropylene. Used in clinical settings for infection control; protects wearer and patient from fluid/particulate transfer. Single-use; non-sterile; blue color; 175mm x 95mm dimensions.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F2100-2019, ASTM F1862/F1862M-17, ASTM F2299/F2299M-03, and EN 14683:2019. Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
## Technological Characteristics
Three-layer construction: spun-bond polypropylene (inner/outer), melt blown polypropylene (middle). Nose clip: iron wire/polyethylene. Ear loops: spandex/nylon. Dimensions: 175mm x 95mm. Performance: ASTM F2100-2019 Level 2. Biocompatibility: ISO 10993-5, ISO 10993-10. Flammability: 16 CFR Part 1610 Class I.
## 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
- Disposable Medical Surgical Face Masks ([K202211](/device/K202211.md))
## Submission Summary (Full Text)
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May 13, 2021
Biobase Scientific (Shandong) Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 China
Re: K210815
Trade/Device Name: Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 15, 2021 Received: March 18, 2021
Dear Diana Hong:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
Clarence w. Murray, III, Ph.D. Acting Assistant Director Sterility Device Team DHT4A: Division of General 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K210815 Device Name Disposable Face Mask
Indications for Use (Describe)
The Disposable 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.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
> Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The
assigned 510(k) Number: K210815
- 1. Date of Preparation: 05/06/2021
- 2. Sponsor Identification
### Biobase Scientific (Shandong) Co., Ltd.
NO.1777 Dazheng Road, High-Tech District, Jinan City, Shandong Province, China. Establishment
Registration Number: 3016747986.
Contact Person: Qingxiang Hou Position: RA Specialist Tel: +86-531-81219858 Fax: +86-531-81219804 Email: 17806167195@163.com
- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
# Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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#### 4. Identification of Proposed Device
Trade Name: Disposable Face Mask Common Name: Surgical Face Mask Model: BK-DSFM Size: 175mm×95mm
Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
Indication for use:
The Disposable 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 Description:
The Disposable Face Mask is single use, three-layer, flat-pleated mask with ear loops and nose clip. The inner and outer layers of the mask are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The ear loops are made of spandex and nylon. The nose clip is a malleable iron wire covered by polyethylene. Users can adjust the nose clip according to the shape of the nose and fix the mask on the bridge of the nose to prevent the mask from falling off. The Disposable Face Mask is blue and provided non-sterile.
#### 5. Identification of Predicate Device
510(k) Number: K202211 Product Name: Disposable Medical Surgical Face Masks
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- Summary of Technological Characteristics 6.
Provided below is the technological characteristic comparing the subject device and the predicate device.
| ITEM | Subject Device K210815 | Predicate Device K202211 | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | The Disposable Face Mask is
intended to be worn to protect both
the patient and healthcare
personnel from transfer of
microorganisms, body fluids and
particulate material. The face
mask is intended for use in
infection control practices to
reduce potential exposure to blood
and body fluids. The face mask is
a single use, disposable
device, provided non-sterile. | The Disposable Medical 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(s),
provided non-sterile. | Same |
| Design feature | Ear loop | Ear loop | Same |
| Color | Blue | Blue | Same |
| Dimension | 175mm×95mm | 175mm×95mm | Same |
| Level | Level 2 | Level 2 | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Fluid resistance | 32 out of 32 per lot pass at 120
mmHg, 3 non-consecutive lots
tested | 32 out of 32 per lot pass at 120
mmHg, 3 non-consecutive lots
tested | Same |
| Particulate
Filtration
Efficiency | 3 non-consecutive lots tested,
using a sample size of 32/lot.
Lot 1: 99.30%
Lot 2: 99.46%
Lot 3: 99.47% | 3 non-consecutive lots tested,
using a sample size of 32/lot.
Lot 1:99.68%
Lot 2:99.56%
Lot 3:99.81% | Different |
Table 1 Comparison of Disposable Face Mask
Page 3 of 6
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| 510(k) Summary | | | | |
|---------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------|--|
| | 3 non-consecutive lots tested, using a sample size of 32/lot. | 3 non-consecutive lots tested, using a sample size of 32/lot. | | |
| Bacterial
Filtration
Efficiency | Lot 1: 99.40% | Lot 1:99.9% | Different | |
| | Lot 2: 99.45% | Lot 2:99.9% | | |
| | Lot 3: 99.46% | Lot 3:99.9% | | |
| | 3 non-consecutive lots tested, using a sample size of 32/lot.
Lot 1: $2.05 mm H_2O/cm^2$ | 3 non-consecutive lots tested, using a sample size of 32/lot.
Lot 1: $3.6 mm H_2O/cm^2$ | Different | |
| Differential Pressure | Lot 2: $1.95 mm H_2O/cm^2$ | Lot 2: $3.6 mm H_2O/cm^2$ | | |
| | Lot 3: $2.03 mm H_2O/cm^2$ | Lot 3: $3.7 mm H_2O/cm^2$ | | |
| | Class 1, 3 non-consecutive lots | Class 1, 3 non-consecutive lots | Same | |
| Flammability | tested, using a sample size of
32/lot. | tested, using a sample size of
32/lot. | | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | |
| Patient Contacting Material | | | | |
| Outer facing layer | Spun-bond polypropylene | Spun-bond nonwoven fabric | | |
| Middle layer | Melt blown polypropylene filter | Melt blown non-woven fabric | | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond nonwoven fabric | Different | |
| Nose clip | Malleable polyethylene wire and
iron | PE and iron wire | | |
| Ear loop | Spandex and nylon | Spandex and nylon | | |
| Biocompatibility | | | | |
| Cytotoxicity | ISO 10993-5 and ISO 10993-10; | ISO 10993-5 and ISO 10993-10; | | |
| | Under the conditions of the study, | Under the conditions of the study, | | |
| Sensitization | the proposed device extract was | the proposed device extract was | | |
| | determined to be non-cytotoxic, | determined to be non-cytotoxic, | Same | |
| | non-sensitizing, and | non-sensitizing, and | | |
| Irritation | non-irritating. | non-irritating. | | |
| | | | | |
#### 7. 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
Page 4 of 6
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### 510(k) Summary
Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- > ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
- > ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ハ ASTM F2100-2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- > EN 14683: 2019 Medical face masks- Requirements and test methods
- > ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
| No. | Performance
Test | Sample
Size | Test
Meth | Acceptance
Criteria | Test Result | | | Evidence |
|-----|------------------------------|----------------|----------------------------------|-----------------------------|----------------------------------|----------------------------------|----------------------------------|-----------------------|
| | | | | | Lot #1:
20070721 | Lot #2:
20071021 | Lot #3:
20072221 | Reports: |
| 1 | Bacterial
Filtration
n | 32 | ASTM
F2100-19 | Level 2: >98% | Min:
99.03%
Avg:
99.40% | Min:
99.22%
Avg:
99.45% | Min:
99.27%
Avg:
99.46% | 041 to 043;
Passed |
| 2 | Differential
Pressure | 32 | Annex C,
EN
14683:
2019 | Level 2: <6.0
mm H2O/cm² | Max: 2.55
Avg: 2.05 | Max: 2.75
Avg: 1.95 | Max: 2.86
Avg: 2.03 | 044 to 046;
Passed |
### Table 1: Summary of Performance Testing
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| 510(k) Summary | | | | | | | |
|----------------|------------------------------|-----------------------------|-------------------|----------------------------------|----------------------------------|----------------------------------|-----------------------|
| 3 | Flammability | 16 CFR
Part 1610 | Level 2: Class I | Class I | Class I | Class I | 047 to 049;
Passed |
| 4 | Particulate
Filtration | F2299/F2
299M-03 | Level 2: >98% | Min:
99.24%
Avg:
99.50% | Min:
99.25%
Avg:
99.46% | Min:
99.33%
Avg:
99.47% | 050 to 052;
Passed |
| 5 | Resistance to
Penetration | ASTM
F1862/F1
826M-17 | Level 2: 120 mmHg | Pass at
120
mmHg | Pass at
120
mmHg | Pass at
120
mmHg | 053 to 055;
Passed |
## Table 2: Biocompatibility Test Results
| Test | Standard | Report | Result | | | | |
|----------------------------|-------------------|---------------|-------------------------------------------|--|--|--|--|
| In Vitro Cytotoxicity Test | ISO 10993-5-2009 | 2020-0451-001 | Passed: No Cytotoxicity Observed | | | | |
| Skin Sensitization
Test | ISO 10993-10:2010 | 2020-0451-002 | Passed: No Skin
Sensitization Observed | | | | |
| Skin irritation Test | ISO 10993-10:2010 | 2020-0451-003 | Passed: No Skin
irritation Observed | | | | |
#### 8. Clinical Test Conclusion
No clinical study is included in this submission.
#### 9. 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 cleared under K202211.
---
**Source:** [https://fda-staging.innolitics.com/device/K210815](https://fda-staging.innolitics.com/device/K210815)
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