(231 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended to protect against transfer of microorganisms and fluids; it does not provide therapeutic treatment.
No
The surgical face mask is clearly described as being "intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." It functions as a barrier or protective device, not one that gathers or analyzes data for diagnosis.
No
The device description clearly outlines a physical, multi-layer surgical face mask made of materials like polypropylene and aluminum wire, with performance studies focused on filtration efficiency, pressure, and resistance to penetration, all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical construction of a face mask, not a device designed to analyze biological samples.
- Performance Studies and Key Metrics: The performance studies and metrics (BFE, Delta-P, PFE, synthetic blood penetration, flame spread) are related to the physical filtration and barrier properties of the mask, not to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
- 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.
Performance Testing for Level 2:
- Bacterial filtration efficiency (BFE) ASTM F2101-19: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot A: 99.89%, Lot B: 99.89%, Lot C: 98.87%. Pass.
- Differential pressure, (Delta-P) EN 14683:2019, Annex C: 3 non-consecutive lots tested, using a sample size of 32/lot. 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 filltration efficiency at 0.1 micron. ASTM F2299: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot A: 98.36%, Lot B: 98.49%, Lot C: 98.43%. Pass.
- Resistance to penetration by synthetic blood ASTM F1862: Level 2: 32 out of 32 pass at 120mmHg, 3 non-consecutive tested. Pass.
- Flame spread 16 CFR Part 1610: Class1, 3 non-consecutive tested, using a sample size of 32/lot. Pass.
Biocompatibility evaluation:
- In vitro Cytotoxicity Test per ISO 10993-5:2009: Noncytotoxic. Pass.
- Skin Sensitization Tests per ISO 10993-10:2010: Nonsensitizing. Pass.
- Skin Irritation Tests per ISO 10993-10:2010: Nonirritating. Pass.
All tests were passed. No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
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. 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) 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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3
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 |
4
| 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
5
Crown Name Disposable Hygiene Products Fty., Ltd. Sponsor: Subject Device: Surgical face mask,Model:Flat Ear loop/CN102
| Elements of
| Comparison | Subject Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | Crown Name Disposable | |||
| Hygiene Products Fty., Ltd. | Wuhan Dymex Healthcare | |||
| Co., Ltd | -- | |||
| Product Name | Surgical face mask | Surgical Face Mask | -- | |
| K Number | K203534 | K182515 | -- | |
| Product Code | FXX | FXX | Same | |
| Regulation | ||||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Intended use/ | ||||
| Indications for Use | The Surgical face mask(Model: | |||
| Flat Ear Loop/CN102) is | ||||
| indicated as a protective nose | ||||
| and mouth covering for | ||||
| healthcare workers and | ||||
| patients involved in medical | ||||
| and surgical procedures. The | ||||
| mask is indicated in any | ||||
| procedure or situation where | ||||
| there is a risk of | ||||
| microorganism, body fluid and | ||||
| particulate aerosol transfer. The | ||||
| product is a single | ||||
| use,disposable device(s), | ||||
| provided non-sterile. | 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 blood and body | ||||
| fluids. 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 | Outer | |||
| facing | ||||
| layer | spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Middle | ||||
| layer | Melt blown polypropylene filter | Melt blown polypropylene | ||
| filter | Same | |||
| Inner | ||||
| facing | ||||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose | ||||
| piece | Outer plastic, inner aluminum | |||
| wire | Malleable polyethylene wire | Different | ||
| Note 1 | ||||
| Ear | ||||
| loops | Spandex | Spandex | Same | |
| Color | Blue | Yellow | Different | |
| Note 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 F2100 | ||||
| Level | Level 2 | Level 2 | Same | |
| Fluid resistance | ||||
| Performance | ||||
| ASTM F1862 | Level 2:32 out of 32 pass at | |||
| 120mmHg,3non-consecutive | ||||
| lots tested. | 32 out of 32 pass at 120 mmHg | Similar | ||
| Particle Filtration | ||||
| Efficiency | ||||
| 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% | 98.46% | Similar Note 3 | ||
| Bacterial Filtration | ||||
| Efficiency | ||||
| ASTM 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 | ||
| Flammability | ||||
| Class | ||||
| 16 CFR 1610 | Class1, 3 non-consecutive lots | |||
| tested,using a sample size of | ||||
| 32/lot. | Class 1 | |||
| Non Flammable | Similar | |||
| Differential | ||||
| Pressure(Delta –P) | 3 non-consecutive lots tested, | |||
| using a sample size of 32/lot. | ||||
| Level 2: | ||||
| Lot A: 3.3 mm H2O/cm² | ||||
| Lot B: 3.3 mm H2O/cm² | ||||
| Lot C: 3.3 mm H2O/cm² | ||||
| (EN 14683:2019,Annex C) | 4.2mmH2O/cm² | |||
| (MIL-M-36954C) | Similar Note 3 | |||
| Biocompatibility | ISO10993-5 and | |||
| ISO10993-10;Under the | ||||
| conditions of the studies | ||||
| employed, the device is | ||||
| non-cytotoxic, non-sensitizing, | ||||
| and non-irritating. | ISO10993-5 and | |||
| ISO10993-10; | ||||
| Under the conditions of the | ||||
| studies employed, the | ||||
| device is non-cytotoxic, | ||||
| non-sensitizing, and | ||||
| non-irritating. | Same |
6
7
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)
8
-
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) | Test
results |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------|
| Bacterial
filtration
efficiency (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/cm²
Lot B: 3.3 mm H₂O/cm²
Lot C: 3.3 mm H₂O/cm² (EN
14683:2019,Annex C) | Delta-P
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 is | |
| noncytotoxic. | Pass | |
| Irritation | Under the conditions of the study, the device is | |
| nonirritating. | Pass | |
| Sensitization | Under the conditions of the study, the device is | |
| nonsensitizing | 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).