(86 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 Masks are single use, three-layer, flat –folded masks with ear loops/tie coverall and nose clamp. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of Nylon and spandex and the ties are made of polypropylene nonwoven. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PP coated steel wire. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold non- sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study that proves the device meets those criteria for a Surgical Face Mask (K212368) manufactured by Anhui Tiankang Medical Technology Co., Ltd.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Synthetic Blood Penetration ASTM F1862 | Demonstrate resistance to liquid penetration | ≥ 29 samples out of 32 pass (AQL 4%) - Level 1: pass at 80mmHg - Level 2: pass at 120mmHg - Level 3: pass at 160mmHg | Pass |
| Particulate Filtration Efficiency ASTM F2299 | Demonstrate particulate filtration | 29 out of 32 pass - Level 1: pass at ≥95% - Level 2: pass at ≥98% - Level 3: pass at ≥98% | Pass |
| Bacterial Filtration Efficiency ASTM F2101 | Demonstrate bacterial filtration | 29 out of 32 pass - Level 1: pass at ≥95% - Level 2: pass at ≥98% - Level 3: pass at ≥98% | Pass |
| Differential Pressure (Delta P) EN 14683 Annex C | Demonstrate breathability | 29 out of 32 pass - Level 1: pass at ≤ 5.0 mmH₂0/cm² - Level 2: pass at ≤ 6.0 mmH₂0/cm² - Level 3: pass at ≤ 6.0 mmH₂0/cm² | Pass |
| Flammability 16 CFR 1610 | Demonstrate flame resistance | Class I | Pass |
| Cytotoxicity ISO 10993-5 | Demonstrate cytotoxic biocompatibility | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| Skin Irritation ISO 10993-10 | Demonstrate non-irritability | Under the conditions of the study, the device is non-irritating. | Pass |
| Skin Sensitization ISO 10993-10 | Demonstrate non-sensitization | Under the conditions of the study, the device is non-sensitizing. | Pass |
2. Sample size used for the test set and the data provenance
The sample sizes for the functional performance tests (Synthetic Blood Penetration, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure) were 32 samples for each test. For these tests, the acceptance criteria are generally "≥ 29 samples out of 32 pass".
The document does not explicitly state the country of origin for the studies, nor if they were retrospective or prospective. However, given that these are non-clinical performance tests for a device submitted to the FDA by a company in China, it is highly likely that the tests were conducted in a laboratory setting, potentially in China or a certified testing facility elsewhere. They are by nature prospective tests, performed specifically to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the described studies are non-clinical performance tests of a physical product (surgical face mask), not diagnostic or interpretative studies requiring human expert ground truth.
4. Adjudication method for the test set
This information is not applicable for these types of mechanical and biological compatibility tests. The results are typically objectively measured by instruments or laboratory methods.
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
There was no MRMC study conducted. This document describes the performance testing of a physical medical device (surgical face mask), not an AI-powered diagnostic tool.
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 algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on objective measurements and chemical/biological assays as defined by recognized international and national standards (ASTM, EN, ISO, CFR). For example:
- Synthetic Blood Penetration: Measured resistance to fluid penetration at specific pressures.
- Particulate/Bacterial Filtration Efficiency: Measured percentage of particles/bacteria filtered.
- Differential Pressure: Measured breathability in mmH₂0/cm².
- Flammability: Determined by specific flame resistance classifications.
- Biocompatibility (Cytotoxicity, Skin Irritation, Sensitization): Determined by laboratory assays evaluating cellular responses or skin reactions under specified conditions.
8. The sample size for the training set
This information is not applicable as the described device is a physical product and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the described device is a physical product and not an AI/machine learning model.
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October 24, 2021
Anhui Tiankang Medical Technology Co., Ltd. Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, Shanghai 200122 China
Re: K212368
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 30, 2021 Received: July 30, 2021
Dear Eva Li:
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,
For 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 Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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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Anhui Tiankang Medical Technology Co.,Ltd. No. 228 Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China
510(k) Summary
510(k) Number: K212368 A.
B. Sponsor
Anhui Tiankang Medical Technology Co.,Ltd. Address: No. 228 Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China Contact Person: Zhang Yong Tel: +86-13705505106
C. Date Prepared: September 23, 2021
D. Submission Correspondent
Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
Subject Device E.
Trade Name: Surgical Face Mask Model(s):
| Model# | Description |
|---|---|
| WKKZ.R.LEVEL1-001 | Ear loop, Flat pleated, 3 layers |
| WKKZ.R.LEVEL2-001 | |
| WKKZ.R.LEVEL3-001 | |
| WKKZ.J.LEVEL1-001 | |
| WKKZ.J.LEVEL2-001 | |
| WKKZ.J.LEVEL3-001 | |
| WKKZ.J.LEVEL1-001 | Tie-on, Flat pleated, 3 layers |
| WKKZ.J.LEVEL2-001 | |
| WKKZ.J.LEVEL3-001 |
Regulatory Information Classification Name: Mask, Surgical Classification: Class II Product code: FXX Regulation Number: 878.4040 Regulation Name: Surgical Apparel
F. Predicate device:
K110455 Kimberly-Clark KC100 Mask Kimberly-Clark
G. 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 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.
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Anhui Tiankang Medical Technology Co.,Ltd.
No. 228 Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China
H. Device Description:
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops/tie coverall and nose clamp.
The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of Nylon and spandex and the ties are made of polypropylene nonwoven.
The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PP coated steel wire.
The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold non- sterile and are intended to be single use, disposable devices.
l. Comparison of Technological Characteristics
| Table 1 General Comparison | ||||
|---|---|---|---|---|
| Device | Proposed Device | Predicate Device | Comparison | |
| Manufacturer | Anhui Tiankang MedicalTechnology Co.,Ltd. | Kimberly-Clark | ||
| 510(K) number | K212368 | K110455 | ||
| Model Name | Surgical Face Mask | Kimberly-Clark KC100 Mask | Similar | |
| Classification | Class II Device, FXX(21 CFR878.4040) | Class II Device, FXX(21 CFR878.4040) | Same | |
| Indications For Use | The Surgical Face Masks areintended 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 potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile. | The Kimberly-Clark KC100Procedure Mask(s) is intendedto be worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. TheKimberly-Clark KC100 ProcedureMask(s) is a single use,disposable devices, providednon- sterile. | Same | |
| Description | Ear loop, Tie-On, Flatpleated, 3 layers | Ear Loops, Tie-On, FlatPleated, 3 layers | Same | |
| Outer facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Middlelayer | Melt blownpolypropylene filter | Melt blown polypropylenefilter | Same | |
| Innerfacing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Material | Noseclamp | PP coated steel wire | N/A | Different |
| Ear loops | Nylon and spandex;PP nonwoven | Polyester/lycra knitted | Different | |
| Ties | ||||
| Color | Blue | Variety (include blue) | Similar |
Table 1 General Comparison
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Anhui Tiankang Medical Technology Co.,Ltd. No. 228 Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China
| (length) | ||||
|---|---|---|---|---|
| Dimension(width) | $95 \pm 2.85mm$ | $102 \pm 19mm$ | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single use, Disposable | Single use, Disposable | Same | |
| ASTM F2100Level | Level 1Level 2Level 3 | Level 1 | Similar | |
| Biocompatibility | CytotoxicityISO 10993-5 | Non-cytotoxic under theconditions of the study | Non-cytotoxic under theconditions of the study | Same |
| SkinSensitivity ISO10993-10 | Non-sensitizer under theconditions of the study | Non-sensitizer under theconditions of the study | Same | |
| Skin IrritationISO 10993-10 | Non-irritating under theconditions of the study | Non-irritating under theconditions of the study | Same |
The proposed device has different material of nose clamp and ear loop/ties to the predicate device, but the material has been tested and the test results shown that the material differences do not affect device performance. The subject device conducted testing to demonstrate compliance with ASTM F2100 with the different models meeting the Level 1, Level 2, and Level 3 criteria, while the predicate device met the ASTM F2100 Level 1 criteria.
J. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject 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:
| Item | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Synthetic BloodPenetrationASTM F1862 | Demonstrate resistanceto liquid penetration | ≥ 29 samples out of32 pass (AQL 4%)Level 1 pass at 80mmHgLevel 2 pass at 120mmHgLevel 3 pass at 160mmHg | Pass |
| ParticulateFiltrationEfficiency ASTMF2299 | Demonstrateparticulate filtration | 29 out of 32 passLevel 1 pass at ≥95%Level 2 pass at ≥98%Level 3 pass at ≥98% | Pass |
| BacterialFiltrationEfficiency ASTMF2101 | Demonstrate bacterialfiltration | 29 out of 32 passLevel 1 pass at ≥95%Level 2 pass at ≥98%Level 3 pass at ≥98% | Pass |
| DifferentialPressure(Delta P)EN 14683 AnnexC | Demonstratebreathability | 29 out of 32 passLevel 1 pass at≤ 5.0 mmH₂0/cm²Level 2 pass at≤ 6.0 mmH₂0/cm²Level 3 pass≤ 6.0 mmH₂0/cm² | Pass |
| Flammability16 CFR 1610 | Demonstrate flameresistance | Class I | Pass |
| CytotoxicityISO 10993-5 | Demonstrate cytotoxicbiocompatibility | Under the conditions of the study, the device isnon-cytotoxic. | Pass |
| Skin IrritationISO 10993-10 | Demonstrate non-irritability | Under the conditions of the study, the device isnon-irritating. | Pass |
Table 2: Non-clinical performance testing
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Anhui Tiankang Medical Technology Co.,Ltd.
No. 228 Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China
| SkinSensitizationISO 10993-10 | Demonstrate non-sensitization | Under the conditions of the study, the device isnon-sensitizing | Pass |
|---|---|---|---|
| --------------------------------------- | ------------------------------- | --------------------------------------------------------------------- | ------ |
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);
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;
16 CFR 1610, Standard for the Flammability of clothing textiles;
Summary of Clinical Performance Tests K.
No clinical study is included in this submission.
L. Conclusion
Based on the nonclinical tests performed, the subject Surgical Face Masks are as safe, as effective, and perform as well as or better than the legally marketed predicate device, Kimberly-Clark KC100 Mask cleared under K110455.
§ 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.