(245 days)
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.
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.
This document is a 510(k) summary for a Disposable Surgical Face Mask. The information provided is primarily focused on the non-clinical performance and biocompatibility testing of the device to demonstrate substantial equivalence to previously cleared predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance Performance (mmHg) | Claimed at 160 mm Hg | PASS (at 160 mm Hg) |
| Particulate Filtration Efficiency Performance (%) | ≥ 98% | PASS |
| Bacterial Filtration Efficiency Performance (%) | ≥ 98% | PASS |
| Differential Pressure (Delta-P) (mm H2O/cm²) | < 6.0 mm H2O/cm² | PASS |
| Flammability Class | Class 1 | PASS (Class 1) |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Irritation | Non-irritating | Non-irritating |
| Sensitization | Non-sensitizing | Non-sensitizing |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the individual performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability) or the biocompatibility tests (Cytotoxicity, Irritation, Sensitization). The testing methods are referenced (e.g., ASTM F1862/F1862M-17, ASTM F2299-03, ASTM F2101-14, EN 14683: 2019, 16 CFR Part 1610, ISO 10993-5: 2009, ISO 10993-10: 2010), which would typically define the sample sizes used for such tests.
The data provenance is not mentioned in terms of country of origin or whether the data was retrospective or prospective, as these are non-clinical (laboratory) tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device and testing. The "ground truth" for non-clinical performance and biocompatibility of a surgical face mask is established by validated standardized test methods and their predefined acceptance criteria, not by expert consensus or interpretations of images/data by human experts.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies when interpreting subjective outcomes or discrepancies among multiple readers/experts. For these non-clinical tests, the results (e.g., pass/fail, numerical values) are objective outcomes of the specified test methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. This document describes a surgical face mask, which is not a diagnostic device.
6. Standalone (Algorithm Only) Performance:
Not applicable. There is no algorithm or AI component in a Disposable Surgical Face Mask. The device is a physical product, and its performance is measured through direct laboratory testing.
7. Type of Ground Truth Used:
The ground truth for the device's performance is established by the standardized test methods and their predetermined acceptance criteria outlined in the referenced standards (e.g., ASTM F2100: 2019, ISO 10993 series). These standards define what constitutes a "PASS" for each characteristic (e.g., ≥98% for PFE, <6.0 mm H2O/cm² for Differential Pressure).
8. Sample Size for the Training Set:
Not applicable. There is no "training set" for this device. Training sets are relevant for machine learning algorithms, which are not part of a surgical face mask.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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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
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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,
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
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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)
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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.
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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.
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| 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 ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Company | Guangdong BidaMedicalTechnology Co.,Ltd. | SAN-M PACKAGE CO.,LTD. | 3M Health Care | -- |
| 510 (k) | K202387 | K160269 | K191355 | -- |
| Trade Name | Disposable SurgicalFace Mask | Surgical Face Masks(Ear loops and Tie-on) | 3MTM HightFluid-ResistantProcedure Mask | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Class II | Same |
| Product Code | FXX | FXX | FXX | Same |
| Intended use | Disposable SurgicalFace Mask isintended to be wornto protect bothpatients andhealthcarepersonnel fromtransfer ofmicroorganisms,blood and bodyfluids, andparticulates | The surgical face masksare intended to be wornto protect both thepatient and healthcarepersonnel from transferof microorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure to | 3MTM HightFluid-ResistantProcedure Mask isintended to be worn toprotect both the patientand healthcarepersonnel fromtransfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended for | Same |
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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| face masks areintended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids.The face mask issingle use,disposable devicesprovide non-sterile. | This is a single-use,disposable device,provided non-sterile. | practices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device,provided non-sterile. | ||
| Materials | ||||
| Outer facinglayer | PolypropyleneSpunbond | Polypropylene | PolypropyleneSpunbond, green | SimilarNote 4 |
| Middle filterlayer | Polypropylene Meltblown | - Polypropylenespunbond- Polypropylenemeltblown | PolypropyleneMeltblown, white | SimilarNote 4 |
| Inner facinglayer | PolypropyleneSpunbond | Polypropylene | PolyethyleneThermal-bonded, white | SimilarNote 4 |
| Nose piece | Polyethylenecoated iron wire | Polyethylene coatedsteel wire | Polyethylene CoatedSteel Wire | SimilarNote 4 |
| Ear loops | Spandex | Polyester, polyurethane | Spandex elastic cord(polyurethane corewith polyethyleneterephthalate /nyloncover) | DifferentNote 1 |
| Designfeatures | Color: Blue,Ear loops, | Colors: white or blueVisor option: polyester | Color: Green (Outer)Tie Strings and Earloops | DifferentNote 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 mmWidth:180 ± 5 mm | -Length: 6.9" ± 0.2"-Width: 3.5" ± 0.3" | DifferentNote 2 |
| OTC use | Yes | Yes | Yes | Same |
Report by Guangdong Bida Medical Technology Co., Ltd.
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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number: | K202387 |
| Elements ofComparison | 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 |
| PerformanceTesting | Level 3 | Level 1; Level 2; Level 3 | Level 3 | Same |
| FluidResistancePerformance | Pass at 160 mm Hg | For Level 3:Pass at 160 mm Hg | Passed at 160mm Hg | Same |
| ParticulateFiltrationEfficiency | ≥98% | For Level 3:Pass at 99.7% | Passed at ≥98% @0.1micron | Same |
| BacterialFiltrationEfficiency | ≥ 98% | For Level 3:Pass at >99% | Passed at ≥98% | Same |
| DifferentialPressure | <6.0 mm H2O/cm2 | For Level 3:Pass at 2.5 mm H2O/cm2 | Passed at <5 mmH2O/cm2 | DifferentNote 3 |
| Flammability | Class 1 | Class 1 | Class 1 | Same |
| Biocompatibility | ||||
| Cytotoxicity | Under theconditions of thestudy, the subjectdevice wasnon-cytotoxic. | Under the conditions ofthe study, the subjectdevice wasnon-cytotoxic. | Non-cytotoxic | Same |
| Irritation | Under theconditions of thestudy, the subjectdevice wasnon-irritating. | Under the conditions ofthe study, the subjectdevice wasnon-irritating. | Non-irritating | Same |
| Sensitization | Under theconditions of thestudy, the subjectdevice was non-sensitizing. | Under the conditions ofthe study, the subjectdevice was non-sensitizing. | Non-sensitizing | Same |
Comparison in Detail(s):
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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |
Note 1:
Although the "Nose piece" and "Ear loop" of subject device is a little different from the predicate devices, but they all met the ASTM F2100 and ISO 10993 standards required. So, the differences between the subject device and the predicate devices will not affect the safety and effectiveness.
Note 2:
Although the "Design features" and "Dimensions" of subject device is a little different from predicate devices, but they all met the ASTM F2100 and ISO 10993 standards required. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
Note 3:
Although the "Differential Pressure" of subject device is a little different from predicate devices, but they all met the ASTM F2100 standard required. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
Note 4:
Although the materials in "Outer facing layer", "Middle filter layer" and "Nose piece" of subject device is a little different from predicate devices, but they all met the ISO 10993 series standard requirements. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
8. Summary of Non-Clinical Performance Testing
Performance Testing summary:
| PerformanceCharacteristics | Test Method | AcceptanceCriteria | TestResults/Verdict |
|---|---|---|---|
| Fluid ResistancePerformance(mmHg) | ASTM F1862/F1862M-17 StandardTest Method for Resistance ofMedical Face Masks to Penetrationby Synthetic Blood (HorizontalProjection of Fixed Volume at aKnown Velocity) according to ASTMF2100: 2019 | Fluid resistantclaimed at 160mm Hg | PASS |
| ParticulateFiltration EfficiencyPerformance (%) | ASTM F2299-03 Standard TestMethod for Determining the InitialEfficiency of Materials Used inMedical Face Masks to Penetrationby Particulates Using Latex | ≥ 98% | PASS |
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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|---|---|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |
| Spheres according to ASTMF2100: 2019 | |||
|---|---|---|---|
| Bacterial FiltrationEfficiencyPerformance (%) | ASTM F2101-14 Standard TestMethod for Evaluating the BacterialFiltration Efficiency (BFE) ofMedical Face Mask Materials,Using a Biological Aerosol ofStaphylococcus aureus accordingto ASTM F2100: 2019 | ≥ 98% | PASS |
| DifferentialPressure (Delta-P)(mm H2O/cm²) | EN 14683: 2019, Annex C Medicalface masks - Requirements andtest methods according to ASTMF2100: 2019 | <6.0 mmH2O/cm² | PASS |
| Flammability classClass 1 | 16 CFR Part 1610 Standard for theFlammability of Clothing accordingto ASTM F2100: 2019 | Class 1 | PASS |
Biocompatibility Testing Summary:
According to ISO 10993-1: 2018, the nature of body contact for the subject device is the Surface Device category, Skin Contact, and duration of the contact is Prolonged (>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 Biologicalevaluation of medical devices-Part 5: Tests for in vitrocytotoxicity | Under the conditions of the study, thesubject device extract wasdetermined to be non-cytotoxic. | PASS |
| Irritation | ISO 10993-10: 2010 Biologicalevaluation of medicaldevices-Part 10: Tests forirritation and skin sensitization | Under the conditions of the study, thesubject device non-polar and polarextracts were determined to benon-irritating. | PASS |
| Sensitization | ISO 10993-10: 2010 Biologicalevaluation of medicaldevices-Part 10: Tests forirritation and skin sensitization | Under the conditions of the study, thesubject device non-polar and polarextracts were determined to benon-sensitizing. | PASS |
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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.
§ 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.