(86 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device description indicates and its intended use is to protect from microorganisms and fluids, not to treat or diagnose a disease or condition.
No
The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (spunbond polypropylene, meltblown polypropylene filter, elastic ear loops, nose clip) and performance testing related to material properties and physical barriers, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Surgical Mask Function: The description clearly states the surgical mask is intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Testing on Samples: The device description and performance studies focus on the physical properties and filtration capabilities of the mask itself (resistance to penetration, filtration efficiency, breathability, flammability). There is no mention of the mask being used to test or analyze biological samples.
Therefore, based on the provided information, the surgical mask is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 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, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.
Resistance to Penetration by Synthetic blood 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)
Purpose: The test was performed in accordance with ASTM F1862-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) to evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids.
Acceptance Criteria: No penetration at 120 mmHg
Results: Pass at 120mmHg
Bacterial Filtration Efficiency 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
Purpose: The test was performed in accordance with ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, using a Biological Aerosol of Staphylococcus aureus to determine the bacterial filtration efficiency (BFE) of the test article.
Acceptance Criteria: >=98%
Results: Average 99.9%
Particulate Filtration Efficiency 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
Purpose: The test was performed in accordance with ASTM F2299-03 (Reapproved 2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres, to determine the Particle Filtration Efficiency.
Acceptance Criteria: >=98%
Results: Average 98.8%
Differential Pressure EN 14683:2019 Medical face masks-Requirements and test methods
Purpose: The test was performed in accordance with EN 14683:2019 Medical face masks-Requirements and test methods, to determine the differential pressure.
Acceptance Criteria:
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2021
Bain Medical Equipment (Guangzhou) Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China
Re: K203524
Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 10, 2020 Received: December 1, 2020
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
1
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 CAPT Elizabeth Claverie, M.S. 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
2
Indications for Use
510(k) Number (if known) K203524
Device Name Surgical Masks
Indications for Use (Describe)
The 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, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
-
- Date of Preparation: 01/29/2021
-
- Sponsor Identification
Bain Medical Equipment (Guangzhou) Co., Ltd.
No.10 Juncheng Road, Eastern Area, Economic & Technological Development District, Guangzhou, China, 510760
Establishment Registration Number: 3013217742.
Contact Person: Mu Fangzhen Position: Management Representative Tel: +86-20-66856868 ext.287 Fax: +86-20-32067500 Email: mufangzhen@baingz.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Surgical Masks Common Name: Surgical Face Mask Size: 17.5cm×9.5cm
Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
Indication for use:
The 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, provided non-sterile.
Device Description:
The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.
- ર. Identification of Predicate Device
510(k) Number: K153496 Product Name: Disposable Surgical Face Mask
6. Summary of Non-Clinical Testing
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.
5
K203524
| Name of the Test
| Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Resistance to Penetration | |||
| by Synthetic blood | |||
| 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) | The test was performed in | ||
| accordance with ASTM | |||
| F1862-17 Standard Test | |||
| Method for Resistance of | |||
| Medical Face Masks to | |||
| Penetration by Synthetic | |||
| Blood (Horizontal | |||
| Projection of Fixed Volume | |||
| at a Known Velocity) to | |||
| evaluate the effectiveness of | |||
| the test sample from | |||
| possible exposure to blood | |||
| and other body fluids | No penetration at | ||
| 120 mmHg | Pass at | ||
| 120mmHg | |||
| Bacterial Filtration | |||
| Efficiency | |||
| 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 | The test was performed in | ||
| accordance with ASTM | |||
| F2101-19 Standard Test | |||
| Method for Evaluating the | |||
| Bacterial Filtration | |||
| Efficiency (BFE) of Medical | |||
| Face Mask Materials, using | |||
| a Biological Aerosol of | |||
| Staphylococcus aureus to | |||
| determine the bacterial | |||
| filtration efficiency (BFE) of | |||
| the test article. | ≥98% | Average 99.9% | |
| Particulate Filtration | |||
| Efficiency | |||
| 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 | The test was performed in | ||
| accordance with ASTM | |||
| F2299-03 (Reapproved |
- Standard Test Method
for Determining the Initial
Efficiency of Materials Used
in Medical Face Masks to
Penetration by Particulates
Using Latex Spheres, to
determine the Particle
Filtration Efficiency | ≥98% | Average 98.8% |
| Differential Pressure
EN 14683:2019 Medical
face masks-
Requirements and test
methods | The test was performed in
accordance with EN
14683:2019 Medical face
masks-Requirements and
test methods, to determine
the differential pressure. |