(56 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.
No.
The intended use states that the device protects from microorganisms, body fluids, and particulate material in infection control practices, rather than treating or preventing a disease or condition in a patient.
No
A diagnostic device is used to identify or analyze a disease or condition. This device, a face mask, is intended to protect against the transfer of microorganisms and fluids, which is a PREVENTATIVE measure, not a diagnostic one.
No
The device description clearly outlines physical components (three-layer mask, ear loops, nose clip) and the performance studies focus on material properties and physical performance, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical construction of the mask, materials used, and how it is worn. There is no mention of reagents, test strips, or any components used to analyze a biological sample.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, pressure, flammability, resistance to penetration) and biocompatibility. These are relevant to a barrier device, not a diagnostic test.
- Key Metrics: The key metrics measured (Bacterial Filtration Efficiency, Differential Pressure, etc.) are related to the mask's ability to filter and provide a barrier, not to the accuracy of a diagnostic result.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This face mask does not perform any such function.
N/A
Intended Use / 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.
Product codes
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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
- 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
Summary of Performance Testing:
- Bacterial Filtration: Sample Size 32, Test Method ASTM F2100-19, Acceptance Criteria Level 2: >98%. Test Results: Lot #1: Min: 99.03%, Avg: 99.40%; Lot #2: Min: 99.22%, Avg: 99.45%; Lot #3: Min: 99.27%, Avg: 99.46%. Passed.
- Differential Pressure: Sample Size 32, Test Method Annex C, EN 14683: 2019, Acceptance Criteria Level 2: 98%. Test Results: Lot #1: Min: 99.24%, Avg: 99.50%; Lot #2: Min: 99.25%, Avg: 99.46%; Lot #3: Min: 99.33%, Avg: 99.47%. Passed.
- Resistance to Penetration: Sample Size 32, Test Method ASTM F1862/F1826M-17, Acceptance Criteria Level 2: 120 mmHg. Test Results: Pass at 120 mmHg for all 3 lots. Passed.
Biocompatibility Test Results:
- In Vitro Cytotoxicity Test: Standard ISO 10993-5-2009. Result: Passed: No Cytotoxicity Observed.
- Skin Sensitization Test: Standard ISO 10993-10:2010. Result: Passed: No Skin Sensitization Observed.
- Skin Irritation Test: Standard ISO 10993-10:2010. Result: Passed: No Skin Irritation Observed.
No clinical study is included in this submission.
Key Metrics
Bacterial Filtration Efficiency (BFE):
Lot 1: 99.40%
Lot 2: 99.45%
Lot 3: 99.46%
Differential Pressure:
Lot 1: 2.05 mm H2O/cm²
Lot 2: 1.95 mm H2O/cm²
Lot 3: 2.03 mm H2O/cm²
Particulate Filtration Efficiency:
Lot 1: 99.30%
Lot 2: 99.46%
Lot 3: 99.47%
Flammability: Class I
Fluid resistance: Pass at 120 mmHg
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
1
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
2
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)
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3
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
-
- Date of Preparation: 05/06/2021
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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
5
- 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
6
| 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
7
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: 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.