(231 days)
The surgical face mask(Model: Flat Ear Loop/CN102) are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These 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.
The surgical face mask is pleated three-layer mask. The inner and outer layers are made of spun-bond polypropylene. The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue15:3 /CAS number:147-14-8), which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the surgical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the surgical face mask is in the middle layer of surgical face mask to allow the user to fit the surgical face mask around their noses, which is made of malleable aluminum wire coated with polypropylene resin.All of the material used in the construction of the new masks are being used in currently marketed devices.
The dimensions of each surgical face mask are length 175±10 mm and width 90±10 mm,The dimensions of nose piece is length 110±10 mm, and the ear loop is length 180±20 mm. The surgical face mask are sold non-sterile and are intended to be single use,disposable devices.
The document describes the non-clinical tests performed to demonstrate that the Crown Name Disposable Hygiene Products Fty., Ltd. Surgical face mask (Model: Flat Ear Loop/CN102) meets the acceptance criteria for a Level 2 surgical mask according to ASTM F2100.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item (Performance Level 2) | Acceptance Criteria (Level 2) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) ASTM F2101-19 | BFE ≥ 98% | Lot A: 99.89%, Lot B: 99.89%, Lot C: 98.87% | Pass |
| Differential Pressure (Delta-P) EN 14683:2019, Annex C | Delta-P < 6.0 mm H₂O/cm² | Lot A: 3.3 mm H₂O/cm², Lot B: 3.3 mm H₂O/cm², Lot C: 3.3 mm H₂O/cm² | Pass |
| Sub-micron Particulate Filtration Efficiency (PFE) at 0.1 micron ASTM F2299 | PFE ≥ 98% | Lot A: 98.36%, Lot B: 98.49%, Lot C: 98.43% | Pass |
| Resistance to Penetration by Synthetic Blood ASTM F1862 | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Pass |
| Flame Spread 16 CFR Part 1610 | Class 1: Burn time ≥ 3.5 seconds | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Device is non-cytotoxic | Pass |
| Irritation (ISO 10993-10:2010) | Non-irritating | Device is non-irritating | Pass |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | Device is non-sensitizing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (BFE, Delta-P, PFE, Synthetic Blood Resistance, Flame Spread):
- Sample Size: 3 non-consecutive lots were tested. For each lot, a sample size of 32 devices (or samples from devices) was used.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that "non-clinical tests were conducted." Given the context of a 510(k) submission, these are typically laboratory-based, prospective performance tests conducted by the manufacturer or a contracted lab.
For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization):
- Sample Size: Not explicitly stated, but typically these tests involve standardized in-vitro or in-vivo (animal) models, not human subjects, and follow specific protocols for sample numbers.
- Data Provenance: Similar to performance tests, these are laboratory-based, prospective tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical mask, and its performance is evaluated through standardized non-clinical laboratory tests against established numerical criteria (e.g., BFE %, PFE %, pressure resistance). There is no "ground truth" derived from expert interpretation in the way there would be for an AI diagnostic device evaluating medical images. The acceptance criteria are objective performance measures.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The results are quantitative measurements against predefined criteria, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI diagnostic device, and no human-in-the-loop studies were performed or are relevant for a surgical mask.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device. The tests performed assess the physical and filtration properties of the mask itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective, standardized laboratory test methods (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE, ASTM F1862 for synthetic blood resistance, EN 14683 for differential pressure, 16 CFR Part 1610 for flammability, and ISO 10993 for biocompatibility). The results are quantitative measurements compared against predefined regulatory and standard criteria for a Level 2 surgical mask.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
July 21, 2021
Crown Name Disposable Hygiene Products Fty., Ltd. Ying Fang Manager Chengbei Industrial Zone, Zhucheng Ave, Xinzhou District Wuhan, Hubei 431400 China
Re: K203534
Trade/Device Name: Surgical face mask (Model: Flat Ear Loop/CN102) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 8, 2021 Received: April 21, 2021
Dear Ying Fang:
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. 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
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Indications for Use
510(k) Number (if known) K203534
Device Name
Surgical face mask (Model: Flat Ear Loop/CN102)
Indications for Use (Describe)
The surgical face mask(Model: Flat Ear Loop/CN102) are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These 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.
| 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
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR
807.92.
The assigned 510(k) Number: K203534
Summary Prepared Date:July 7, 2021
1. Submitter Information
Sponsor Name: Crown Name Disposable Hygiene Products Fty., Ltd.
Address: Chengbei Industrial Zone,Zhucheng Ave,Xinzhou District,Wuhan,Hubei,
431400,CHINA.
- Contact Person (including title): Ying Fang (Manger) �
- ◆ Phone:+86-27-82761940
- ◆ Fax: +86-27-82761339
- ◆ E-mail :eric-shi2020@outlook.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical face mask |
| Trade Name: | Surgical face mask (Model: Flat Ear Loop/ CN102) |
| Classification Name: | Mask,Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
Predicate Device Information 3.
Predicate Device
| Sponsor: | Wuhan Dymex Healthcare Co., Ltd |
|---|---|
| Common Name: | Surgical Face Mask |
| Trade Name: | Surgical Face Mask |
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| 510(k) number: | K182515 |
|---|---|
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | ============================================================================================================================================================================== |
4. Device Description
The surgical face mask is pleated three-layer mask. The inner and outer layers are made of spun-bond polypropylene. The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue15:3 /CAS number:147-14-8), which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the surgical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the surgical face mask is in the middle layer of surgical face mask to allow the user to fit the surgical face mask around their noses, which is made of malleable aluminum wire coated with polypropylene resin.All of the material used in the construction of the new masks are being used in currently marketed devices.
The dimensions of each surgical face mask are length 175±10 mm and width 90±10 mm,The dimensions of nose piece is length 110±10 mm, and the ear loop is length 180±20 mm. The surgical face mask are sold non-sterile and are intended to be single use,disposable devices.
5. Intended Use / Indications for Use
The surgical face mask(Model: Flat Ear Loop/CN102) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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.
6. Comparison with predicate device
Table 1 General Comparison
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Crown Name Disposable Hygiene Products Fty., Ltd. Sponsor: Subject Device: Surgical face mask,Model:Flat Ear loop/CN102
| Elements ofComparison | Subject Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | Crown Name DisposableHygiene Products Fty., Ltd. | Wuhan Dymex HealthcareCo., Ltd | -- | |
| Product Name | Surgical face mask | Surgical Face Mask | -- | |
| K Number | K203534 | K182515 | -- | |
| Product Code | FXX | FXX | Same | |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Intended use/Indications for Use | The Surgical face mask(Model:Flat Ear Loop/CN102) isindicated as a protective noseand mouth covering forhealthcare workers andpatients involved in medicaland surgical procedures. Themask is indicated in anyprocedure or situation wherethere is a risk ofmicroorganism, body fluid andparticulate aerosol transfer. Theproduct is a singleuse,disposable device(s),provided non-sterile. | The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile. | Same | |
| Mask style | Flat pleated, 3 layers. | Flat pleated, 3 layers. | Same | |
| Design feature | Ear loop | Ear loop | Same | |
| Material | Outerfacinglayer | spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middlelayer | Melt blown polypropylene filter | Melt blown polypropylenefilter | Same | |
| Innerfacinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nosepiece | Outer plastic, inner aluminumwire | Malleable polyethylene wire | DifferentNote 1 | |
| Earloops | Spandex | Spandex | Same | |
| Color | Blue | Yellow | DifferentNote 1 | |
| Dimension (Width) | 17.5cm±1.0cm | 17.5cm±0.2cm | Different Note 2 | |
| Dimension (Length) | 9.0cm±1.0cm | 9.5cm±0.2cm | Different Note 2 | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100Level | Level 2 | Level 2 | Same | |
| Fluid resistancePerformanceASTM F1862 | Level 2:32 out of 32 pass at120mmHg,3non-consecutivelots tested. | 32 out of 32 pass at 120 mmHg | Similar | |
| Particle FiltrationEfficiencyASTM F2299 | 3 non-consecutive lots tested,using a sample size of 32/lot.Level 2:Lot A: 98.36%Lot B: 98.49%Lot C: 98.43% | 98.46% | Similar Note 3 | |
| Bacterial FiltrationEfficiencyASTM F2101 | 3 non-consecutive lots tested,using a sample size of 32/lot.Level 2:Lot A: 99.89%Lot B: 99.89%Lot C: 98.87% | 98.7% | Similar Note 3 | |
| FlammabilityClass16 CFR 1610 | Class1, 3 non-consecutive lotstested,using a sample size of32/lot. | Class 1Non Flammable | Similar | |
| DifferentialPressure(Delta –P) | 3 non-consecutive lots tested,using a sample size of 32/lot.Level 2:Lot A: 3.3 mm H2O/cm²Lot B: 3.3 mm H2O/cm²Lot C: 3.3 mm H2O/cm²(EN 14683:2019,Annex C) | 4.2mmH2O/cm²(MIL-M-36954C) | Similar Note 3 | |
| Biocompatibility | ISO10993-5 andISO10993-10;Under theconditions of the studiesemployed, the device isnon-cytotoxic, non-sensitizing,and non-irritating. | ISO10993-5 andISO10993-10;Under the conditions of thestudies employed, thedevice is non-cytotoxic,non-sensitizing, andnon-irritating. | Same |
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The materials of the current nose piece and the colors were different from the predicate device.
The biocompatibility evaluation test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.
Note 2
Compare with the predicate and reference device, the different of the physical feature or size does not affect the intended use of the subject device.
Note 3
For the Performance testing, the test results are not identical to each other, but they are similar and they both meet the requirement of Level 2 medical mask according to the ASTM F 2100.
7. Summary of Non-Clinical Tests Performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications as to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
-
ASTM F2299-03(2017), Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
-
EN 14683:2019,Annex C.Method for determination of breathability (differential pressure)
-
ASTM F1862/ASTM F1862M-17, Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
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-
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
-
16 CFR Part 1610, Standard for the flammability of clothing textiles.
-
ISO 10993-5:2009, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Table 2:Performance Testing
| Test item(Performance Level 2) | Proposed device | Acceptance criteria(Level 2) | Testresults |
|---|---|---|---|
| Bacterialfiltrationefficiency (BFE)ASTM F2101-19 | 3 non-consecutive lots tested,using a sample size of 32/lot.Level 2:Lot A: 99.89%Lot B: 99.89%Lot C: 98.87% | BFE≥98%. | Pass |
| Differential pressure,(Delta-P)EN 14683:2019,Annex C | 3 non-consecutive lots tested,using a sample size of 32/lot.Level 2:Lot A: 3.3 mm H₂O/cm²Lot B: 3.3 mm H₂O/cm²Lot C: 3.3 mm H₂O/cm² (EN14683:2019,Annex C) | Delta-P<6.0H₂O/cm² | Pass |
| Sub-micron particulatefilltration efficiency at 0.1micron.ASTM F2299 | 3 non-consecutive lots tested,using a sample size of 32/lot.Level 2:Lot A: 98.36%Lot B: 98.49%Lot C: 98.43% | PFE≥98%. | Pass |
| Resistance topenetration by syntheticblood ASTM F1862 | Level 2:32 out of 32 pass at120mmHg,3non-consecutivetested. | 29 out of 32 pass at120mmHg | Pass |
| Flame spread16 CFR Part 1610 | Class1,3 non-consecutivetested,using a sample size of32/lot | Class 1:Burntime≥3.5 seconds | Pass |
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Results:All tests were passed.
Biocompatibility evaluation and test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and
ISO10993-1:2018 supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- ハ In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
-
Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices —Part 10: Tests for irritation and skin sensitization
-
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices-
Part 10: Tests for irritation and skin sensitization.
| Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device isnoncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device isnonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device isnonsensitizing | Pass |
8. Summary of Clinical Performance Test
No clinical study is included in this submission.
9. Final Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Surgical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Surgical Face Masks (K182515).
§ 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.