(40 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The Surgical Face Masks are blue color, four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer, second facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.
The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the second facing layer is made of nylon single way filting net, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.
The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.
The document describes the acceptance criteria and the results of non-clinical tests for a Surgical Face Mask (HNFM0304) to demonstrate its substantial equivalence to a predicate device (K212097).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria for Level 3 Barrier (as per ASTM F2100) | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥98% | Passed (≥98%) |
| Differential Pressure (EN 14683:2019 Annex C) | Determine breathability of the mask | <6.0 mmH2O/cm² | Passed (<6.0 mmH2O/cm²) |
| Sub-micron Particulate Filtration Efficiency (ASTM F2299-17) | Measure initial particle filtration efficiency | ≥98% | Passed (≥98%) |
| Resistance to Penetration Synthetic Blood (ASTM F1862-17) | Evaluate the resistance to penetration by small volume of synthetic blood | 29 out of 32 pass at 160 mmHg | Passed (32 out of 32 pass at 160 mmHg) |
| Flammability (16 CFR Part 1610-2008) | Response of materials to heat and flame | Class I | Passed (Class I) |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Biological effect | Non-cytotoxic | Passed (Non-cytotoxic) |
| Biocompatibility: Sensitization (ISO 10993-10) | Biological effect | Non-sensitizing | Passed (Non-sensitizing) |
| Biocompatibility: Irritation (ISO 10993-10) | Biological effect | Negligibly irritating | Passed (Negligibly irritating) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for individual mechanical and filtration tests (e.g., number of masks tested for BFE). However, for Resistance to Penetration by Synthetic Blood, the result explicitly states "32 out of 32 pass at 160 mmHg," indicating a sample size of 32 masks for this specific test.
For Biocompatibility Testing, the document mentions a "biocompatibility evaluation for the Surgical Face Mask was conducted," implying that the testing was performed on the device materials. The specific number of samples (e.g., cell cultures, animal subjects) for cytotoxicity, sensitization, and irritation tests is not provided in this summary.
The data provenance is from non-clinical tests conducted in line with international standards (ASTM, EN, ISO) and FDA guidance for surgical masks. The country of origin of the data is not explicitly mentioned but is presumably related to the manufacturer (Shanghai Hua En Industrial Co Ltd, China) or contracted testing laboratories. The document describes these as non-clinical tests, not retrospective or prospective human studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes non-clinical performance and biocompatibility testing, not clinical studies involving expert interpretation or "ground truth" establishment in the context of medical image analysis or diagnostic performance. The ground truth for these tests is defined by the objective measurement criteria of the respective standards (e.g., percentage filtration, pressure drop, cell viability).
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. The tests are objective measurements against predefined criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical surgical face mask, not an AI algorithm or a software device.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established by objective measurement against predefined criteria specified in recognized international standards (e.g., ASTM F2100, EN 14683, ISO 10993). For example:
- Filtration Efficiency: Measured percentage of particles/bacteria blocked.
- Differential Pressure: Measured pressure drop across the material.
- Synthetic Blood Resistance: Observation of penetration at a specific pressure.
- Biocompatibility: In vitro (cytotoxicity) and in vivo (sensitization, irritation) laboratory test results against established biological response criteria.
8. The Sample Size for the Training Set
This information is not applicable. The document describes testing of a physical medical device (surgical face mask), not a machine learning model, so there is no training set in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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June 6, 2022
Shanghai Hua En Industrial CO LTD % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K221222
Trade/Device Name: Surgical Face Mask (HNFM0304) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 27, 2022 Received: April 27, 2022
Dear Ivy Wang:
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.
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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K221222
Device Name Surgical Face Mask (HNFM0304)
Indications for Use (Describe)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided nonsterile.
| Type of Use (Select one or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
(As requirement by 21 CFR 807.92)
Date prepared: 1st, June, 2022
A. Applicant:
Name: SHANGHAI HUA EN INDUSTRIAL CO LTD Address: #30, NO988 HUI JI ROAD, XUANQIAO TOWN, PUDONG,SHANGHAI CHINA 201314 Contact: Lisa Zhao Title: General Manager Tel: +86- 15618875177 Email: lisa.zhao@hnind.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device: Trade Name: Surgical Face Mask Model: HNFM0304
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device: K212097 Disposable medical surgical mask Hebei Titans Hongsen Medical Technology Co., Ltd
D. Indications for use of the device:
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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Surgical Face Masks are blue color, four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer, second facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.
The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the second facing layer is made of nylon single way filting net, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.
The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.
F. Non-clinical Test Conclusion
The Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
| Test Methodology | Purpose | Acceptance Criteria for Level3 Barrier | Result |
|---|---|---|---|
| Bacterial FiltrationEfficiencyASTM F2101 | Measure bacterial filtrationefficiency | ≥98% | Passed |
| Differential Pressure(mmH2O/cm²)EN 14683:2019Annex C | Determine breathability ofthe mask | <6.0 mmH2O/cm² | Passed |
| Sub-micronParticulate FiltrationEfficiency ASTMF2299-17 | Measure initial particlefiltration efficiency | ≥98% | Passed |
| Resistance to | Evaluate the resistance to | 29 out of 32 pass at 160 mmHg | Passed |
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K221222 Page 3 of 5
SHANGHAI HUA EN INDUSTRIAL CO LTD #30, N0988 HUI JI ROAD, XUANQIAO TOWN, PUDONG,SHANGHAI CHINA 201314
| PenetrationSynthetic BloodASTM F1862-17 | by penetrationsmall volume of syntheticblood | by impact of | ||
|---|---|---|---|---|
| Flammability16 CFR Part1610-2008 | Response of materials toheat and flame | Class I | Passed |
Biocompatibility Testing
The biocompatibility evaluation for the Surgical Face Mask was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Surgical Face Mask is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.
| Biocompatibility Evaluation | ||||
|---|---|---|---|---|
| Biological Effect | Standard | Result | ||
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Passed |
| 2 | Sensitization | ISO 10993-10 | Non-sensitizing | Passed |
| 3 | Irritation | ISO 10993-10 | Negligibly irritating | Passed |
G. Summary of Technological Characteristics
Table 1 Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | - | K212097 | - |
| Manufacturer | SHANGHAI HUA EN INDUSTRIAL CO LTD | Hebei Titans Hongsen Medical Technology Co., Ltd | - |
| Product Name | Surgical Face Mask | Disposable medical surgical mask | Similar |
| Level | Level 3 | Level 3 | Same |
| Product Code | FXX | FXX | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications foruse | The Surgical Face Mask is intended to be worn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids andparticulate material. The Surgical FaceMask is intended for use in infectioncontrol practices to reduce the potentialexposure to blood and body fluids. This asingle use, disposable device(s), provided | The Disposable medical surgical mask isintended to be worn to protect both thepatient and healthcare personnel from thetransfer of microorganisms, body fluids,and particulate material. The surgicalmask is intended for use in infectioncontrol practices to reduce the potentialexposure to blood and body fluids. Thisis a single-use, disposable device(s),provided non-sterile. | Same |
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SHANGHAI HUA EN INDUSTRIAL CO LTD #30, NO988 HUI JI ROAD, XUANQIAO TOWN, PUDONG,SHANGHAI CHINA 201314
| non-sterile. | |||
|---|---|---|---|
| Design Feature | Ear loops, flat pleated, 4 layers | Ear loops, flat pleated, 3 layers | Different |
| Color | Blue | Blue | Same |
| Dimension | Length: 180 $\pm$ 5mmWidth: 95 $\pm$ 5mm | 17.5 $\pm$ 5% cm9.5 $\pm$ 5%cm | Similar |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Material | |||
| Outer facinglayer | spun-bond polypropylene | polypropylene spunbond fabric | Same |
| Second facinglayer | nylon single way filting net | N/A | Different |
| Middle layer | melt blown polypropylene | polypropylene meltblown fabric | Same |
| Inner facinglayer | spun-bond polypropylene | polypropylene spunbond fabric | Same |
| Nose clip | polypropylene wrapped aluminium | polypropylene coated steel wire | Different |
| Ear loops | Nylon, spandex | Nylon, spandex | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
Table 2 Performance Characteristic Comparison
| Item | Proposed Device | Predicate Device | ASTM F2100Requirements | Comparison |
|---|---|---|---|---|
| ASTM F2100 Level | Level 3 | Level 3 | Level 3 | Same |
| Bacterial FiltrationEfficiency | ≥98% | ≥99% | ≥98% | Similar |
| Differential Pressure(mmH2O/cm²) | <6.0 mmH2O/cm² | <4.9 mmH2O/cm² | <6.0 mmH2O/cm² | Similar |
| Sub-micron ParticulateFiltration Efficiency | ≥98% | ≥99% | ≥98% | Similar |
| Resistance to Penetrationby Synthetic Blood | 32 out of 32 pass at160 mmHg | 32 out of 32 pass at 160 mmHg | 29 out of 32 pass at160 mmHg | Same |
| Flammability | Class I | Class I | Class I | Same |
Difference Analysis:
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-
The proposed device has different layer number than the predicate device. The additional second facing layer of the proposed device is designed to improve filtration efficiency, which will not cause safety and effectiveness concerns.
-
The material of nose clip of the proposed device is different to the predicate device. However, biocompatibility test has been performed on the final form of the proposed device according to ISO 10993-5 and ISO 10993-10 and the results do not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
H. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. 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 Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
-
ISO 10993-05:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- A EN 14683, Medical Face Masks - Requirements and Test Methods
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
-
ASTM F2299. Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles
Clinical Test Conclusion I.
No clinical study is included in this submission.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K212097.
§ 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.