(20 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a surgical mask intended for protection and infection control, not for treating or curing a medical condition.
No
The device, a surgical mask, is intended to protect from transfer of microorganisms and particulate material, and is not used to diagnose a medical condition.
No
The device description clearly outlines a physical product (surgical masks) made of various non-woven fabrics and includes performance studies related to material properties and filtration, not software functionality.
No, 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 and materials of the mask, which are designed for filtration and barrier protection.
- Performance Studies: The performance studies focus on metrics related to filtration efficiency, fluid resistance, breathability, flammability, and biocompatibility. These are all relevant to the physical barrier function of a mask, not to diagnosing a condition or analyzing a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This surgical mask does not perform such a function.
N/A
Intended Use / Indications for Use
The Surgical 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/ sterile.
Product codes
FXX
Device Description
The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Face Masks are manufactured with three layers. The outer layer is made of spunbonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of polypropylene (PP) fabric.
The Surgical Masks are single use, disposable device, provided non-sterile/sterile.
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 / Not Found
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
Non clinical performance tests were conducted to verify that the proposed device met all design specifications.
Study Type: Non-clinical performance tests
Sample Size: Not specified for all tests, but for Fluid Resistance Performance, 32 out of 32 units passed.
AUC: Not Found
MRMC: Not Found
Standalone performance:
- Fluid Resistance Performance (ASTM F1862M-17): 32 out of 32 pass at 120mmHg
- Particulate Filtration Efficiency (ASTM F2299): 95.8~96.8%
- Bacterial Filtration Efficiency (ASTM F2101-19): 98.3~99.2%
- Differential Pressure (EN 14683:2019 Annex C): 3.7~3.8 mmH2O/cm²
- Flammability (16 CFR 1610): non flammable
Key Results: The proposed device complies with the listed standards and met all design specifications.
Key Metrics
- Fluid Resistance Performance: 32 out of 32 passed at 120mmHg
- Particulate Filtration Efficiency: 95.8~96.8%
- Bacterial Filtration Efficiency: 98.3~99.2%
- Differential Pressure: 3.7~3.8 mmH2O/cm²
- Flammability: non flammable
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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September 8, 2020 Hunan Heng Chang Pharmaceutical Co., Ltd. % Shelley Li Director Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai. 200071 China
Re: K202354
Trade/Device Name: Surgical Mask-Model Number CW01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2020 Received: August 19, 2020
Dear Shelley 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,
For CAPT Elizabeth Claverie, M.S. 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) K202354
Device Name Surgical Mask
Indications for Use (Describe)
The Surgical 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/ sterile.
Type of Use (Select one or both, as applicable)
| Registration Use (Part 21 CFR 201.2 Subject to Review) | Over-The-Counter Use (21 CFR 201.2 Subject to Review) |
|---|---|
| --------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------- |
_ | 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: K202354
I Submitter
Hunan Heng Chang Pharmaceutical Co., Ltd.
Floor 2, 3, 102 of Building 16, Standard Plant of Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Kaifu District, Changsha 410000, China
Contact person: Tao Jingfeng Position: QC Manager Tel.: ++86-18774961605 E-mail: taojingfeng@hcyy.com
Preparation date: Aug. 27, 2020
II Proposed Device
| Trade Name of Device: | Surgical Mask |
|---|---|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |
| 510(k) Number: | K202354 |
III Predicate Devices
| 510(k) Number: | K153496 |
|---|---|
| Trade name: | Disposable Surgical Face Mask |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | Xiantao Rayxin Medical Product Co., Ltd |
IV Device description
The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Face Masks are manufactured with three layers. The outer layer is made of spunbonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer
1
4
contact with face is made of polypropylene (PP) fabric.
The Surgical Masks are single use, disposable device, provided non-sterile/sterile.
V Indication for use
The Surgical 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/sterile.
| Item | Proposed device
(K202354) | Predicate device
(K153496) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Surgical Mask | Disposable Surgical Face
Mask |
| Product Code | FXX | FXX |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 |
| Class | Class II | Class II |
| Mask style | Flat-pleated, ear loop, 3
layers | Flat-pleated, ear loop, tie-on,
3 layers |
| Indication for use | The Surgical 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/ sterile. | The Disposable 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. |
| Material | Inner
Spun-bond polypropylene | Spun-bond polypropylene |
VI Comparison of technological characteristics with the predicate devices
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| layer | |||
|---|---|---|---|
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | |
| Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | |
| Ear loop | Spandex + Polyester | Polyester | |
| Nose piece | malleable polyethylene | Malleable aluminum wire | |
| Color | Blue | blue | |
| Length | $17.5 cm±5%$ | $17.5±1cm$ | |
| Width | $9.5 cm±5%$ | $9.5±1cm$ | |
| OTC use | Yes | Yes | |
| sterile | Non-sterile, sterile | Non-sterile | |
| Sterilization method | EO | / | |
| Single for use | Yes | Yes | |
| ASTM F2100 Level | Level 1 | Level 2 | |
| Biocompatibility | Confirm to the requirements of ISO 10993 series standards | Confirm to the requirements of ISO 10993 series standards |
VII Summary of Non-Clinical Testing
Non clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the following standards:
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F1862M- | |||
| 17 | Fluid Resistance | ||
| Performance | 29 out of 32 pass | ||
| at 120mmHg | 32 out of 32 pass | ||
| at 120mmHg | |||
| ASTM F2299 | Particulate Filtration | ||
| Efficiency | ≥95% | 95.8~96.8% | |
| ASTM F2101-19 | Bacterial Filtration | ||
| Efficiency | ≥95% | 98.3~99.2% |
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| EN 14683:2019
Annex C | Differential
Pressure |