(116 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 sterile.
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops 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 ear loops are held in place over the users' mouth and nose by two ear loops welded to the facemask. The loops are made of Nylon and spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold sterilized and are intended to be single use, disposable devices.
The provided text describes the non-clinical performance testing for a surgical face mask (Trade Name: Surgical Face Mask, Model: Earloop17.5*9.5cm, K212264) to demonstrate its substantial equivalence to a predicate device (Kimberly-Clark KC100 Mask, K110455).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 2 acceptance criteria for medical face masks.
| Item | Acceptance Criteria (Level 2) | Result of LOT-WK20201006 | Result of LOT-WK20201204 | Result of LOT-WK20201208 |
|---|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Differential Pressure (Delta P) (EN 14683 Annex C, ASTM F2100-19) | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class I | Class I | Class I | Class I |
Additionally, biocompatibility tests were conducted:
| Item | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity | Non-Cytotoxic | No cytotoxic potential. |
| Irritation | Non-Irritating | The Primary Irritation Indexes for the test article extracts were both calculated to be 0.0 |
| Sensitization | Non-Sensitizing | Not considered a sensitizer |
2. Sample Size and Data Provenance
- Sample Sized used for the test set:
- For Bacterial Filtration Efficiency (BFE), Particulate Filtration Efficiency (PFE), and Differential Pressure (Delta P): AQL 4% (exact number not specified, but this refers to Acceptable Quality Level sampling plans).
- For Synthetic Blood: 32 masks (Pass = ≥ 29 passing, Fail = ≤ 2 passing).
- For Flammability: All samples (number not specified, but the criteria states 3.5 seconds or more burn time is acceptable).
- For Biocompatibility: Not specified, but standard tests were performed (Cytotoxicity, Irritation, Sensitization).
- Data Provenance: The device manufacturer, Nantong Taiweishi Medical Technology Co., Ltd., is located in Nantong City, Jiangsu Province, China. The tests are non-clinical lab tests, not human data. The nature of these tests suggests they were conducted prospectively as part of the device development and submission process.
3. Number of Experts and Qualifications for Ground Truth
This submission pertains to a surgical face mask, which relies on standardized physical and biological performance tests rather than expert interpretation of medical images or clinical outcomes. Therefore, there are no medical experts (e.g., radiologists) involved in establishing ground truth in the traditional sense of medical imaging AI. The "ground truth" is defined by the established ASTM and EN standards and their specific test methodologies.
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based, quantitative, and standardized. There is no human adjudication process involved in these performance tests.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical device (surgical face mask), not an AI-assisted diagnostic tool. Therefore, no MRMC study was performed or is relevant.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical device, not an algorithm. The performance data presented is the "standalone" performance of the manufactured mask under the specified test conditions.
7. Type of Ground Truth Used
The ground truth is based on established industry standards and test methodologies for medical face masks, specifically:
- ASTM F2100 (Standard Specification for Performance of Materials Used in Medical Face Masks)
- ASTM F1862 (Resistance to Penetration by Synthetic Blood)
- EN 14683 (Medical Face Masks-Requirements and Test Methods)
- ASTM F2101 (Bacterial Filtration Efficiency)
- ASTM F2299 (Particulate Filtration Efficiency)
- 16 CFR 1610 (Flammability)
- ISO 10993 series for Biocompatibility (Cytotoxicity, Irritation, Sensitization)
8. Sample Size for the Training Set
Not applicable. This is a physical device requiring manufacturing and quality control, not an AI model requiring a "training set" in the machine learning sense. The tests are for product performance verification.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as above). The "ground truth" for the performance of the manufactured masks is established through the adherence to and results from the specified standard tests.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 13, 2021
Nantong Taiweishi 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: K212264
Trade/Device Name: Surgical Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 12, 2021 Received: October 12, 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 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,
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)
Device Name
Indications for Use (Describe)
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
A. Applicant
Nantong Taiweishi Medical Technology Co., Ltd. Address: Taihangshan Road, New District, Economic Development Zone, Rudong County, Nantong City, Jiangsu Province, China 226400 Contact Person: Zhang Xuewen Tel: 0086-18761789767 Fax: 0086-513-68923222 Date Prepared: November 8, 2021
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
B. Device
Trade Name: Surgical Face Mask
Model(s):
| Model# | Description |
|---|---|
| Earloop17.5*9.5cm | Ear loop, Flat pleated, 3 layers |
Regulatory Information
Classification Name: Surgical Mask Common Name: Surgical Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K110455 Kimberly-Clark KC100 Mask Kimberly-Clark
D. 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
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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 sterile.
E. Device Description:
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops 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 ear loops are held in place over the users' mouth and nose by two ear loops welded to the facemask. The loops are made of Nylon and spandex.
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene.
The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold sterilized and are intended to be single use, disposable devices.
F. Technological Characteristics Comparison
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | NantongTaiweishiMedical Technology Co.,Ltd. | Kimberly-Clark | |
| 510(K) number | K212264 | K110455 | |
| Model Name | Surgical Face Mask | Kimberly-Clark KC100 Mask | Similar |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Intenduse/Indicationsfor Use | The Surgical Face Masksare intended to be wornto protect both thepatient and healthcarepersonnel from transferof microorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided 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 exposure toblood and body fluids. TheKimberly-Clark KC100 ProcedureMask(s) is a single use,disposable devices, providednon-sterile. | Same |
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Nantong Taiweishi Medical Technology Co., Ltd. Taihangshan Road, New District, Economic Development Zone, Rudong County, Nantong City, Jiangsu Province, China 226400
| Description | Ear loop, Flat pleated, 3layers | Ear Loops, Tie-On, Flat Pleated,3 layers | Similar | |
|---|---|---|---|---|
| Material | Outerfacinglayer | Spun-bond polypropylene | Different*1 | |
| Middlelayer | Melt blownpolypropylene filter | nonwoven polyester blends andpolypropylene materials. | ||
| Innerfacinglayer | Spun-bond polypropylene | |||
| Nose clip | Polypropylene | nonwoven polyester | Different*1 | |
| Ear loops | Nylon, Spandex | knitted polyester/lycra ornonwoven polyester. | Different*1 | |
| Color | Blue | Variety (include blue) | Similar | |
| Dimension(length) | $175 \pm 5%(mm)$ | $165 \pm 19mm$ | Similar | |
| Dimension(width) | $95 \pm 5%(mm)$ | $102 \pm 19mm$ | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Sterile | Non-Sterile | Different*2 | |
| Use | Single use, Disposable | Single use, Disposable | Same | |
| ASTM F2100Level | Level 2 | Level 1 | Similar*3 | |
| Biocompatibility | Non-CytotoxicNon-IrritatingNon-Sensitizing | Non-CytotoxicNon-IrritatingNon-Sensitizing | Same |
*1 Different Discussion:
The proposed device has different material of mask body, nose clip and ear loop to the predicate device.
*2 Different Discussion:
The proposed device is sterile, the predicated device is non-sterile. The proposed device was implemented the performance test and biocompatibility test on the sterilized device.
*3 Similar Discussion:
The proposed device passes the Level 2 Acceptance Criteria, the predicate device passes the level 1 Acceptance Criteria. The test and the acceptance is following:
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| ASTM F2100-19 | ||
|---|---|---|
| Level 1 | Level 2 | |
| BFE% ASTM F2101 | $\ge$ 95 | $\ge$ 98 |
| PFE% ASTM 2299 | $\ge$ 95 | $\ge$ 98 |
| Synthetic BloodASTM 1862 | Pass at 80 mmHg | Pass at 120 mmHg |
| Differential pressureEN 14683 | <5.0 mmH20/cm2 | <6.0 mmH20/cm2 |
| Flammability16CFR Part 1610 | Class 1 | Class 1 |
| Sampling: | ||
| AQL 4% for BFE, PFE, Delta P; 32 masks for Synthetic Blood( Pass= $\ge$ 29 passing, | ||
| Fail= $\le$ 2passing | ||
| Flammability: all samples burn time is 3.5 seconds or more ACCEPTABLE (3.5 sec is | ||
| a pass |
G. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. 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 Face Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In A Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For A Irritation And Skin Sensitization
A 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);
A EN 14683, Medical Face Masks-Requirements and Test Methods;
A 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 latexspheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
- A ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices
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| Item | AcceptanceCriteria(level 2) | Result of LOT-WK20201006 | Result of LOT-WK20201204 | Result of LOT-WK20201208 |
|---|---|---|---|---|
| Synthetic BloodPenetrationASTM F1862 | 29 out of 32pass at120mmHg | 32 out of 32 passat 120mmHg | 32 out of 32 passat 120mmHg | 32 out of 32 passat 120mmHg |
| ParticulateFiltrationEfficiency ASTMF2299 | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Bacterial FiltrationEfficiency ASTMF2101 | ≥98% | ≥99% | ≥99% | ≥99.9% |
| DifferentialPressure(Delta P)EN 14683 Annex CASTM F2100-19 | <6.0mmH20/cm² | <6.0 | <6.0 | <6.0 |
| Flammability 16CFR 1610(*IBE=Test articleignited, butextinguished) | Class I | Class I | Class I | Class I |
Table 2-performance Testing
Table3 Biocompatibility Testing
| Item | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditionsof the study, thedevice is non-cytotoxic. | Non-Cytotoxic | No cytotoxic potential. |
| Irritation | Under the conditionsof the study, thedevice is non-irritating. | Non-Irritating | The Primary Irritation Indexes forthe test article extracts were bothcalculated to be 0.0 |
| Sensitization | Under the conditionsof the study, thedevice is non-sensitizing | Non-Sensitizing | Not considered a sensitizer |
H. Summary of Clinical Performance Test
No clinical study is included in this submission.
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I. Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as 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.