(140 days)
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.
The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Galvanized iron wire. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and performance of a Surgical Face Mask (K222483), not an AI-powered diagnostic device. Therefore, the questions related to AI/algorithm performance (such as MRMC studies, standalone performance, training set details, ground truth for training data, expert qualifications, and adjudication methods for specific diagnoses) are not applicable to this submission.
However, I can extract and present the acceptance criteria and study results for this medical device based on the non-clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | Demonstrate resistance to liquid penetration | Level 1: 29 samples out of 32 pass (AQL 4%) at 80mmHg | Pass: 32 out of 32 pass at 80 mmHg (3 lots) |
| Level 2: 29 samples out of 32 pass (AQL 4%) at 120mmHg | Pass: 32 out of 32 pass at 120 mmHg (3 lots) | ||
| Level 3: 29 samples out of 32 pass (AQL 4%) at 160mmHg | Pass: 32 out of 32 pass at 160 mmHg (3 lots) | ||
| Particulate Filtration Efficiency (ASTM F2299) | Demonstrate particulate filtration | Level 1: ≥95% | Pass: Average 98.24% |
| Level 2: ≥98% | Pass: Average 98.75% | ||
| Level 3: ≥98% | Pass: Average 99.67% | ||
| Bacterial Filtration Efficiency (ASTM F2101) | Demonstrate bacterial filtration | Level 1: ≥95% | Pass: Average 99.18% |
| Level 2: ≥98% | Pass: Average 99.20% | ||
| Level 3: ≥98% | Pass: Average 99.21% | ||
| Differential Pressure (Delta P) (EN 14683 Annex C) | Demonstrate breathability | Level 1: ≤ 5.0 mmH2O/cm² (ASTM F2100 implies this for Level 1, though not explicitly stated in table against EN 14683) | Pass: Average 3.75 mmH2O/cm² |
| Level 2: ≤ 6.0 mmH2O/cm² | Pass: Average 4.25 mmH2O/cm² | ||
| Flammability (16 CFR 1610) | Demonstrate flame resistance | Class I Pass | Pass: Class I |
| Cytotoxicity (ISO 10993-5) | Demonstrate cytotoxic biocompatibility | Under the conditions of the study, the device is non-cytotoxic. | Pass: Under the conditions of the study, the device is non-cytotoxic. |
| Skin Irritation (ISO 10993-10) | Demonstrate non-irritability | Under the conditions of the study, the device is non-irritating. | Pass: Under the conditions of the study, the device is non-irritating. |
| Skin Sensitization (ISO 10993-10) | Demonstrate non-sensitization | Under the conditions of the study, the device is non-sensitizing. | Pass: Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
- Synthetic Blood Penetration: "32 samples out of 32 pass" and "3 lots" are mentioned. This suggests at least 32 samples per lot were tested, across 3 lots.
- Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure): The sample size for these specific tests is not explicitly stated, but averages are provided, indicating multiple samples were tested for each.
- Biocompatibility (Cytotoxicity, Skin Irritation, Skin Sensitization): The sample size is not explicitly stated.
- Data Provenance: Not specified, but generally, such tests are conducted by certified testing laboratories commissioned by the manufacturer, Hubei Woozon Healthcare Co.,Ltd., located in China. These are non-clinical in vitro/in vivo tests on the device materials, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document pertains to the performance testing of a physical medical device (surgical face mask) against established industry standards. There is no diagnostic algorithm or ground truth to be established by experts in the context of this submission. The "ground truth" here is adherence to specified technical standards (e.g., minimum filtration efficiency, maximum differential pressure).
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. Test results are determined by objective measurements per standard protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
This is not applicable. This submission concerns a physical medical device, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm for this device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance is defined by established international and national standards (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, ISO 10993 series, EN 14683 Annex C, 16 CFR 1610). The device is tested against these predefined criteria, and its performance is measured directly against those benchmark values.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical medical device undergoing performance testing.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 4, 2023
Hubei Woozon Healthcare Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai, Shanghai 200120 China
Re: K222483
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 22, 2022 Received: December 5, 2022
Dear Boyle 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.
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 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,
Brent Showalter -S
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) K222483
Device Name Surgical Face Mask
Indications for Use (Describe)
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.
| 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) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: Hubei Woozon Healthcare Co.,Ltd. Address: Nongfeng Road, Nonwoven Fabric Industrial Park, Wangzhou Avenue, Pengchang Town, Xiantao City, Hubei, China. Tel: +86-728-3280667 Contact: Li Chunlin Date of Preparation: Aug.8, 2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
| Trade name: | Surgical Face Mask |
|---|---|
| Common name: | Surgical Face Mask |
| Classification name: | Surgical Face Mask |
| Model: | Ear-loop Type |
3.0 Classification
| Production code: | FXX |
|---|---|
| Regulation number: | 21CFR 878.4040 |
| Classification: | Class II |
| Panel: | Surgical Apparel |
4.0 Predicate Device Information
| Manufacturer: | Anhui Tiankang Medical Technology Co., Ltd. |
|---|---|
| Device: | Surgical Face Mask |
| 510(k) number: | K212368 |
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5.0 Device Description
The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Galvanized iron wire. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
6.0 Indication for Use Statement
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.
| Table 1 General Comparison | |||
|---|---|---|---|
| Item | Subject Device | Predicate DeviceK212368 | Remark |
| Product Name | Surgical Face Mask | Surgical Face Mask | -- |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Intended Use&Indications for use | 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 ininfection 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 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 ininfection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | Same |
| Design features | Ear Loops, | Ear loop, Tie-On. | Different |
7.0 Comparison to the Predicate Device
| Table 1 General Comparison |
|---|
| ---------------------------- |
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| Mask Styles | 3 layers | 3 layers | Analysis 1 | ||
|---|---|---|---|---|---|
| Material | Outer facing layer | Polypropylene | Spun-bond polypropylene | SimilarAnalysis 1 | |
| Middle layer | Melt-blown cloth(polypropylene) | Melt blownpolypropylene filter | Same | ||
| Inner Facing layer | Polypropylene | Spun-bond polypropylene | Similar | ||
| Nose piece | Galvanized iron wire | PP coated steel wire | DifferentAnalysis 1 | ||
| Ear loops | Plolyester silk& Polyurethane filament | Ear loops: Nylon andspandex;Ties: PP nonwoven | DifferentAnalysis 1 | ||
| Color | Blue | Blue | Same | ||
| Dimension | Length: 175±4mmWidth: 95±4mm | Length: 175±5mmWidth: 95±2.85mm | SimilarAnalysis 2 | ||
| OTC use | Yes | Yes | Same | ||
| Single Use | Yes | Yes | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| ASTM F2100 Level | Level 1Level 2Level 3 | Level 1Level 2Level 3 | Same | ||
| Biocompatibility | CytotoxicityISO10993-5 | Non-cytotoxic under theconditions of the study | Non-cytotoxic under theconditions of the study | Same | |
| Skin IrritationISO10993-10 | Non-irritating under theconditions of the study | Non-irritating under theconditions of the study | Same | ||
| SkinSensitizationISO10993-10 | Non-sensitizer under theconditions of the study | Non-sensitizer under theconditions of the study | Same |
Analysis 1: The two devices have some difference in design features and materials, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectiveness of device.
Analysis 2: The two devices share same dimensions otherwise the tolerance is different, the little deviation in tolerance does not raise additional questions for safety and effectiveness of device.
8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
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ISO 10993-5: 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
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);
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, stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
16 CFR 1610, Standard for the Flammability of clothing textiles;
| Item | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| SyntheticBloodPenetrationASTMF1862 | Demonstrateresistanceto liquidpenetration | 29 samples out of 32pass (AQL 4%)Level 1 pass at 80mmHg | Pass32 out of 32 pass at 80 mmHg, 3 lots |
| 29 samples out of 32pass (AQL 4%)Level 2 pass at120mmHg | Pass32 out of 32 pass at 120 mmHg, 3 lots | ||
| 29 samples out of 32pass (AQL 4%)Level 3 pass at160mmHg | Pass32 out of 32 pass at 160 mmHg, 3 lots | ||
| ParticulateFiltrationEfficiencyASTMF2299 | Demonstrateparticulatefiltration | Level 1 pass at $≥95%$ | PassAverage 98.24% |
| Level 2 pass at $≥98%$ | PassAverage 98.75% | ||
| Level 3 pass at $≥98%$ | PassAverage 99.67% | ||
| BacterialFiltrationEfficiencyASTMF2101 | Demonstratebacterialfiltration | Level 1 pass at $≥95%$ | PassAverage 99.18% |
| Level 2 pass at $≥98%$ | PassAverage 99.20% | ||
| Level 3 pass at $≥98%$ | PassAverage 99.21% | ||
| DifferentialPressure | Demonstratebreathability | Level 1 pass at $≤ 5.0$ mmH2O/cm² | PassAverage 3.75 mmH2O/cm² |
Table 2 - Performance Testing
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| (Delta P)EN 14683Annex C | Level 2 pass at ≤ 6.0mmH2O/cm² | PassAverage 4.25 mmH2O/cm² |
|---|---|---|
| Flammability16 CFR 1610 | Demonstrate flame resistance | Class IPass |
Table 3 - Biocompatibility Testing
| Item | Purpose | Subject Device | Results |
|---|---|---|---|
| CytotoxicityISO 10993-5 | Demonstrate cytotoxicbiocompatibility | Under the conditions of thestudy, the device isnon-cytotoxic. | Pass |
| Skin IrritationISO10993-10 | Demonstratenon irritability | Under the conditions of thestudy, the device isnon-irritating. | Pass |
| SkinSensitizationISO10993-10 | Demonstratenon sensitization | Under the conditions of thestudy, the device isnon-sensitizing | Pass |
9.0 _Clinical Test Conclusion
No clinical study is included in this submission.
10.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K212368.
§ 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.