(245 days)
Not Found
No
The device description and performance testing focus solely on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.
No
The device is a disposable surgical face mask intended for protection from transfer of microorganisms, blood, and body fluids, not for treating a disease or condition.
No
Explanation: The device is a face mask intended for protection against the transfer of microorganisms and particulates, and its performance metrics relate to filtration and material safety, not diagnosis.
No
The device description clearly outlines a physical, three-layer mask made of non-woven and melt-blown materials, with ear loops and a nose piece. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware devices. There is no mention of software components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is for protecting both patients and healthcare personnel from the transfer of microorganisms, blood, body fluids, and particulates. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, breathability, flammability) and biocompatibility. These are relevant to a barrier device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This surgical face mask does not perform any such function.
N/A
Intended Use / Indications for Use
Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.
Product codes
FXX
Device Description
The subject device is a three-layer and flat-pleated mask. The mask materials consist of non-woven/ outer layer (polypropylene spunbond), melt blown/ filter layer (polypropylene melt-blown) and non-woven/ inner layer (polypropylene spunbond). Each mask contains the ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece to provide a firm fit over the nose.
The subject device is a single-use, disposable device, 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)
Performance Testing summary:
- Fluid Resistance Performance: Test Method ASTMF1862/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) according to ASTM F2100: 2019. Acceptance Criteria: Fluid resistant claimed at 160 mm Hg. Test Results/Verdict: PASS.
- Particulate Filtration Efficiency Performance: Test Method ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres according to ASTM F2100: 2019. Acceptance Criteria: >= 98%. Test Results/Verdict: PASS.
- Bacterial Filtration Efficiency Performance: Test Method ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100: 2019. Acceptance Criteria: >= 98%. Test Results/Verdict: PASS.
- Differential Pressure (Delta-P): Test Method EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100: 2019. 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 shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Guangdong Bida Medical Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District, Guang Guangzhou, Guangdong 510700 China
Re: K202387
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 23, 2021 Received: March 29, 2021
Dear Cassie Lee:
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,
Ryan Ortega, PhD 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202387
Device Name Disposable Surgical Face Mask (Model: MS001)
Indications for Use (Describe)
Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide 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."
3
510(k) Summary of K202387
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary: April 20, 2021
2. Submitter's Information
510(k) Owner's Name: Guangdong Bida Medical Technology Co., Ltd. Establishment Registration Number: Applying Address: No.2, Xingfeng Rd, Shangsha Zhenxing District, Chang'an Town, Dongguan City, Guangdong Province, China Post Code: 523843 Contact name: Zhang Rong Tel: +86-134 3749 2306 E-mail: coco@rohsin.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@glomed-info.com
US Consultant Agent:
Company Name: UGK-LVM United Inc Address: 6547 N Academy Blvd, #2266 Colorado, Springs CO 80918, USA Contact Person: Jimmy Phone: 001-323-5104660 Email: us-agent@glomed-info.com
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: Disposable Surgical Face Mask
Report by Guangdong Bida Medical Technology Co., Ltd.
4
Sponsor: Guangdong Bida Medical Technology Co., Ltd. Disposable Surgical Face Mask (Model: MS001) Subject Device: 510(k) Number K202387
Model Name: MS001 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
Predicate Device Information 4.
Predicate Device 1:
Sponsor: San-M Package Co. Ltd. Trade Name: Surgical Face Masks (Ear loops and Tie-on) Classification Name: Mask, Surgical 510(K) Number: K160269 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
Predicate Device 2:
Sponsor: 3M Health Care Trade Name: 3MTM Hight Fluid-Resistant Procedure Mask Classification Name: Mask, Surgical 510(K) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlatory Class: II
Intended Use / Indications for Use 5.
Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.
6. Device Description
Report by Guangdong Bida Medical Technology Co., Ltd.
5
| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |
The subject device is a three-layer and flat-pleated mask. The mask materials consist of non-woven/ outer layer (polypropylene spunbond), melt blown/ filter layer (polypropylene melt-blown) and non-woven/ inner layer (polypropylene spunbond). Each mask contains the ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece to provide a firm fit over the nose.
The subject device is a single-use, disposable device, provided non-sterile.
7. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Company | Guangdong Bida | |||
| Medical | ||||
| Technology Co., | ||||
| Ltd. | SAN-M PACKAGE CO., | |||
| LTD. | 3M Health Care | -- | ||
| 510 (k) | K202387 | K160269 | K191355 | -- |
| Trade Name | Disposable Surgical | |||
| Face Mask | Surgical Face Masks | |||
| (Ear loops and Tie-on) | 3MTM Hight | |||
| Fluid-Resistant | ||||
| Procedure Mask | -- | |||
| Classification | ||||
| Name | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Class II | Same |
| Product Code | FXX | FXX | FXX | Same |
| Intended use | Disposable Surgical | |||
| Face Mask is | ||||
| intended to be worn | ||||
| to protect both | ||||
| patients and | ||||
| healthcare | ||||
| personnel from | ||||
| transfer of | ||||
| microorganisms, | ||||
| blood and body | ||||
| fluids, and | ||||
| particulates | 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 | 3MTM Hight | |||
| Fluid-Resistant | ||||
| Procedure Mask is | ||||
| 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 | Same |
6
| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| face masks are | ||||
| intended for use in | ||||
| infection control | ||||
| practices to reduce | ||||
| the potential | ||||
| exposure to blood | ||||
| and body fluids. | ||||
| The face mask is | ||||
| single use, | ||||
| disposable devices | ||||
| provide non-sterile. | This is a single-use, | |||
| disposable device, | ||||
| provided non-sterile. | practices to reduce the | |||
| potential exposure to | ||||
| blood and body fluids. | ||||
| This is a single use, | ||||
| disposable device, | ||||
| provided non-sterile. | ||||
| Materials | ||||
| Outer facing | ||||
| layer | Polypropylene | |||
| Spunbond | Polypropylene | Polypropylene | ||
| Spunbond, green | Similar | |||
| Note 4 | ||||
| Middle filter | ||||
| layer | Polypropylene Melt | |||
| blown | - Polypropylene | |||
| spunbond |
- Polypropylene
meltblown | Polypropylene
Meltblown, white | Similar
Note 4 |
| Inner facing
layer | Polypropylene
Spunbond | Polypropylene | Polyethylene
Thermal-bonded, white | Similar
Note 4 |
| Nose piece | Polyethylene
coated iron wire | Polyethylene coated
steel wire | Polyethylene Coated
Steel Wire | Similar
Note 4 |
| Ear loops | Spandex | Polyester, polyurethane | Spandex elastic cord
(polyurethane core
with polyethylene
terephthalate /nylon
cover) | Different
Note 1 |
| Design
features | Color: Blue,
Ear loops, | Colors: white or blue
Visor option: polyester | Color: Green (Outer)
Tie Strings and Ear
loops | Different
Note 2 |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | Same |
| Dimensions | 17.5 cm x 9.5 cm | - Length: 90 ± 3 mm;
Width: 175 ± 5 mm; - Length: 90 ± 3 mm
Width:
180 ± 5 mm | -Length: 6.9" ± 0.2"
-Width: 3.5" ± 0.3" | Different
Note 2 |
| OTC use | Yes | Yes | Yes | Same |
Report by Guangdong Bida Medical Technology Co., Ltd.
7
| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number: | K202387 |
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, | |||
| Disposable | Single Use, Disposable | Single Use, | ||
| Disposable | Same | |||
| Performance | ||||
| Testing | Level 3 | Level 1; Level 2; Level 3 | Level 3 | Same |
| Fluid | ||||
| Resistance | ||||
| Performance | Pass at 160 mm Hg | For Level 3: | ||
| Pass at 160 mm Hg | Passed at 160mm Hg | Same | ||
| Particulate | ||||
| Filtration | ||||
| Efficiency | ≥98% | For Level 3: | ||
| Pass at 99.7% | Passed at ≥98% @ | |||
| 0.1micron | Same | |||
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ≥ 98% | For Level 3: | ||
| Pass at >99% | Passed at ≥98% | Same | ||
| Differential | ||||
| Pressure | 24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: |
| Test Item | Test Method | Proposed device | Result |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5: 2009 Biological | ||
| evaluation of medical devices- | |||
| Part 5: Tests for in vitro | |||
| cytotoxicity | Under the conditions of the study, the | ||
| subject device extract was | |||
| determined to be non-cytotoxic. | PASS | ||
| Irritation | ISO 10993-10: 2010 Biological | ||
| evaluation of medical | |||
| devices-Part 10: Tests for | |||
| irritation and skin sensitization | Under the conditions of the study, the | ||
| subject device non-polar and polar | |||
| extracts were determined to be | |||
| non-irritating. | PASS | ||
| Sensitization | ISO 10993-10: 2010 Biological | ||
| evaluation of medical | |||
| devices-Part 10: Tests for | |||
| irritation and skin sensitization | Under the conditions of the study, the | ||
| subject device non-polar and polar | |||
| extracts were determined to be | |||
| non-sensitizing. | PASS |
10
Summary of Clinical Performance Test 9.
No clinical study is included in this submission.
10. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device K202387 is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K160269 and K191355.