(169 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 composed of mask body, nose clip and ear loops. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex. The size of the Surgical Face Mask is 17.5*9.5cm with tolerance ± 5% cm, the length of the ear loopis 16cm, and the length of the nose clip should no less than 8.0cm. The outer layer of Surgical Face Mask will be provided in blue, the inner layer of the Surgical Face Mask will be provided in white. The Surgical Face Mask will be provided non-sterile and is intended to be single use.
The document describes the non-clinical performance testing of a Surgical Face Mask (Trade/Device Name: Surgical Face Mask, Model: TY123, K212059) to demonstrate its substantial equivalence to a legally marketed predicate device (K182514).
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Subject device Performance | Acceptance Criteria (Level 2) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | No penetration at 120 mmHg | No penetration at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | >99.16% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | 99.9% | ≥ 98% | Pass |
| Differential Pressure (Delta P) EN 14683 Annex C | <5.3mmH2O/cm² | <6.0mmH2O/cm² | Pass |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Pass |
Biocompatibility tests (Cytotoxicity, Irritation, Sensitization according to ISO 10993-5 and ISO 10993-10) also concluded that the device is non-cytotoxic, non-irritating, and non-sensitizing, which aligns with the predicate device's characteristics.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of masks tested for fluid resistance, filtration efficiency, etc.). The provenance of the data is from non-clinical laboratory testing, not human patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the context of patient data. These are laboratory test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is established by standardized laboratory test results against predefined performance metrics, not by expert interpretation of medical images or clinical data.
4. Adjudication method for the test set
Not applicable. The tests are objective laboratory measurements, not subjective evaluations 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 a medical device (surgical face mask) clearance, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is based on established international and national standards for medical face masks and biological evaluation of medical devices. These standards define the acceptable physical and biological performance characteristics. Examples of standards used include ASTM F2100, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, 16 CFR 1610, ISO 10993-5, and ISO 10993-10.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence. This is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
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December 17, 2021
Zhongshan Saifute Labor Protective Articles CO., LTD Qionghua Ke General Manager No.7, Xihuan 4th road, Southern District Zhongshan, Guangdong 528400 China
Re: K212059
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 5, 2021 Received: November 15, 2021
Dear Qionghua Ke:
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,
For Clarence W. Murray III, PhD 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) K212059
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 persomel 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 K212059
A. Applicant Information:
| Name: | ZHONGSHAN SAIFUTE LABOR PROTECTIVE ARTICLES CO., LTD |
|---|---|
| Address: | NO.7, XIHUAN 4TH ROAD, SOUTHERNDISTRICT, ZHONGSHAN, GUANGDONG, CHINA 528400 |
Contact Person: Qionghua Ke +86-13802652169 Tel: Mail: ke.qionghua1@gmail.com
Date of Preparation: December 7, 2021
B. Device Information:
| Trade Name: | Surgical Face Mask |
|---|---|
| Common Name: | Surgical Face Mask |
| Model(s): | TY123 |
Regulatory Information
Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate Device Information:
K182514 SURGICAL FACE MASK The predicate has not been subject to a design-related recall.
D. Device Description:
The Surgical Face Mask is composed of mask body, nose clip and ear loops. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.
The size of the Surgical Face Mask is 17.5*9.5cm with tolerance ± 5% cm, the length of the ear loopis 16cm, and the length of the nose clip should no less than 8.0cm.
The outer layer of Surgical Face Mask will be provided in blue, the inner layer of the Surgical Face Mask will be provided in white. The Surgical Face Mask will be provided non-sterile and is intended to be single use.
E. Indications for use:
The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel
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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 | ||||
|---|---|---|---|---|
| Device | Subject Device (K212059) | Predicate Device (K182514) | Result | |
| Manufacturer | ZHONGSHANSAIFUTELABORPROTECTIVEARTICLES CO., LTD | Xiantao Zhibo Non-wovenProducts Co., Ltd | - | |
| Product Name | Surgical Face Mask | SURGICAL FACE MASK | Similar | |
| Model | TY123 | --- | - | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| Indicationsfor use | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsandparticulate material. Theseface masks are intended for usein infection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsandparticulate material. Theseface masks are intended for usein infection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s),provided non-sterile. | Same | |
| Material | Outerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middlelayer | Melt blown non-woven fabric | Melt blown polypropylene filter | Same |
F. Comparison of Technological Characteristics
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| Spun-bond polypropylene | Spun-bond polypropylene | Same | |
|---|---|---|---|
| Inner layer | Iron wire | Malleable aluminum wire | Different |
| Nose clip | Spandex | Polyester | Different |
| Ear loops | Blue | White | Different |
| Color | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same |
| Design Feature | $17.5 \pm 5%$ | $17.5cm \pm 1cm$ | Similar |
| Dimension (Length) | $9.5cm \pm 5%$ | $9.5cm \pm 1cm$ | Similar |
| Dimension (Width) | Yes | Yes | Same |
| OTC use | Non-Sterile | Non-Sterile | Same |
| Sterility | Single Use, Disposable | Single Use, Disposable | Same |
| Use | Level 2 | Level 2 | Same |
| ASTM F2100 level | Non-cytotoxic, non-sensitizing, and non-irritating | Non-cytotoxic, non-sensitizing, and non-irritating | Same |
| BiocompatibilityISO 10993-5/ISO 10993-10 |
The difference in the materials does not raise additional questions for safety and effectiveness.
G. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as same 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:
- A 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 A
- 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);
-
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;
- A 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.
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| Table 2 - Summary of Performance Testing | |
|---|---|
| ------------------------------------------ | -- |
| Item | Subject device | AcceptanceCriteria (level 2) | Result |
|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862 | No penetrationat 120 mmHg | No penetration at120 mmHg | Pass |
| Particulate FiltrationEfficiencyASTM F2299 | >99.16% | ≥ 98% | Pass |
| Bacterial FiltrationEfficiencyASTM F2101 | 99.9% | ≥ 98% | Pass |
| Differential Pressure (DeltaP)EN14683Annex C | <5.3mmH2O/cm² | <6.0mmH2O/cm² | Pass |
| Flammability 16CFR 1610 | Class 1 | Class 1 | Pass |
Table 3 Summary of Biocompatibility Testing
| Tests | Subject Device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Same |
| Irritation | Under the conditions of the study, the device is non-irritating. | Same |
| Sensitization | Under the conditions of the study, the device is non-sensitizing. | Same |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
Based on the non-clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, K182514.
§ 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.