(116 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
Surgical face masks are protective barriers intended for infection control, not for treating a disease or condition.
No
The device is a surgical face mask intended to protect against transfer of microorganisms and fluids, not to diagnose a condition.
No
The device description clearly outlines physical components (three-layer mask, ear loops, nose clamp) and materials (polypropylene, Nylon, spandex). The performance studies focus on physical properties and filtration efficiency, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask and its components. There is no mention of reagents, assays, or any components used to test samples from the human body.
- Performance Studies and Key Metrics: The performance studies focus on the physical and filtration properties of the mask (BFE, PFE, blood penetration, differential pressure, flammability). These are relevant to its barrier function, not to diagnosing a condition or analyzing a sample.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any such function.
Therefore, the Surgical Face Masks described are considered a medical device with a barrier function, not an In Vitro Diagnostic device.
N/A
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 in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided sterile.
Product codes
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 latexspheres;
- 16 CFR 1610, Standard for the Flammability of clothing textiles;
- 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
Performance results for three lots (LOT-WK20201006, LOT-WK20201204, LOT-WK20201208) were provided for:
- Synthetic Blood Penetration ASTM F1862: All 32 out of 32 samples passed at 120mmHg for all lots (Acceptance Criteria: 29 out of 32 pass at 120mmHg).
- Particulate Filtration Efficiency ASTM F2299: >=99% for all lots (Acceptance Criteria: >=98%).
- Bacterial Filtration Efficiency ASTM F2101: >=99% for all lots (Acceptance Criteria: >=98%).
- Differential Pressure(Delta P) EN 14683 Annex C ASTM F2100-19:
§ 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.
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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
1
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
4
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 | Nantong | ||
| Taiweishi | |||
| Medical 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 (21 | ||
| CFR878.4040) | Class II Device, FXX (21 | ||
| CFR878.4040) | Same | ||
| Intend | |||
| 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 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 Kimberly-Clark KC100 | ||
| Procedure Mask(s) is 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. The | |||
| Kimberly-Clark KC100 Procedure | |||
| Mask(s) is a single use, | |||
| disposable devices, provided | |||
| non-sterile. | Same |
5
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, 3
layers | Ear Loops, Tie-On, Flat Pleated,
3 layers | Similar |
|-----------------------|--------------------------|----------------------------------------------------|-----------------------------------------------------------|-------------|
| Material | Outer
facing
layer | Spun-bond polypropylene | | Different1 |
| | Middle
layer | Melt blown
polypropylene filter | nonwoven polyester blends and
polypropylene materials. | |
| | Inner
facing
layer | Spun-bond polypropylene | | |
| | Nose clip | Polypropylene | nonwoven polyester | Different1 |
| | Ear loops | Nylon, Spandex | knitted polyester/lycra or
nonwoven polyester. | Different1 |
| 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 | Different2 |
| Use | | Single use, Disposable | Single use, Disposable | Same |
| ASTM F2100
Level | | Level 2 | Level 1 | Similar*3 |
| Biocompatibility | | Non-Cytotoxic
Non-Irritating
Non-Sensitizing | Non-Cytotoxic
Non-Irritating
Non-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 Blood | ||
| ASTM 1862 | Pass at 80 mmHg | Pass at 120 mmHg |
| Differential pressure | ||
| EN 14683 |