(169 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
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate materials, which is a preventive function, not a therapeutic one.
No
The intended use of the surgical face mask is to protect against the transfer of microorganisms, body fluids, and particulate materials, not to diagnose a condition.
No
The device description and performance studies clearly indicate a physical surgical face mask made of materials like polypropylene, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the surgical face mask's intended use is to protect against the transfer of microorganisms, body fluids, and particulate materials by being worn on the face. It acts as a physical barrier.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. It does not provide diagnostic information based on biological samples.
The information provided describes a physical barrier device used for personal protection, not a diagnostic tool.
N/A
Intended Use / Indications for Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
Product codes
FXX
Device Description
The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
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
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 tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Test Methodology: Fluid Resistance Performance (ASTM F1862). Results: Lot 1: 32 Out of 32 pass at 160 mmHg; Lot 2: 32 Out of 32 pass at 160 mmHg; Lot 3: 32 Out of 32 pass at 160 mmHg. Pass.
Test Methodology: Particulate Filtration Efficiency (ASTM F2299). Results: Lot 1:99.8%; Lot 2:99.9%; Lot 3: 99.9%. Pass.
Test Methodology: Bacterial Filtration Efficiency (ASTM F2101). Results: Lot 1: > 99.9%; Lot 2: > 99.9%; Lot 3: > 99.9%. Pass.
Test Methodology: Differential Pressure (EN 14683:2019). Results: Lot 1: 3.4 mmH20/cm²; Lot 2: 3.5 mmH20/cm²; Lot 3: 3.3 mmH20/cm². Pass.
Test Methodology: Flammability (16 CFR 1610). Results: Lot 1: Class 1; Lot 2: Class 1; Lot 3: Class 1. Pass.
Test Methodology: Cytotoxicity. Results: Under the conditions of the study, non-cytotoxicity effect.
Test Methodology: Irritation. Results: Under the conditions of the study, non-irritation.
Test Methodology: Sensitization. Results: Under the conditions of the study, non-sensitization.
No clinical tests were performed.
Key Metrics
Fluid Resistance Performance: 32 Out of 32 pass at 160 mmHg (for each of 3 lots).
Particulate Filtration Efficiency: 99.8% (Lot 1), 99.9% (Lot 2 and 3).
Bacterial Filtration Efficiency: > 99.9% (for all 3 lots).
Differential Pressure: 3.4 mmH20/cm² (Lot 1), 3.5 mmH20/cm² (Lot 2), 3.3 mmH20/cm² (Lot 3).
Flammability: Class 1 (for all 3 lots).
Cytotoxicity: Non-Cytotoxic.
Irritation: Non-irritation.
Sensitization: Non-sensitization.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2021
Lucky Textile Industrial(Wuxi) Co.,Ltd. Grace Tai General Manager Assistant No.10 Zhuqiao Road, Yixing Economic and Technological Development Zone , Yixing, Jiangsu, China Yixing, Jiangsu 214200 China
Re: K203756
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 8, 2021 Received: May 13, 2021
Dear Grace Tai:
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 Acting 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) K203756
Device Name Disposable Surgical Mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 601 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 601 Subpart C) |
__ 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
510(k) Number: K203756 Date Prepared: June 10,2021
1.Submission Sponsor
| Manufacturer information | |
|---|---|
| Company: Lucky Textile Industrial(Wuxi) Co.,Ltd. | |
| Company address: No.10 Zhuqiao Road, Yixing | |
| Economic and Technological Development | |
| Zone, Yixing, Jiangsu, China. | |
| Contact person: Grace Tai | |
| Phone: +86-510-80192890 | |
| Fax: / | |
| E-mail: lqsy@luckytextiles.cn |
2. Submission correspondent
| Name | Lucky Textile Industrial(Wuxi) Co.,Ltd. |
|---|---|
| Address/Post Code | No.10 Zhuqiao Road, Yixing Economic and |
| Technological Development Zone , Yixing, Jiangsu, China. | |
| Phone No. | +86-510-80192890 |
| Contact Person | Grace Tai |
| lqsy@luckytextiles.cn |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Surgical Mask |
| Model: | |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4040 |
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4. Legally Marketed Predicate Device
| Trade Name | Surgical face mask |
|---|---|
| Regulation number | 21 CFR 878.4040 |
| Regulation class | II |
| Regulation name | Surgical face mask |
| 510(k) Number | K203756 |
| Product Code | FXX |
| Manufacturer | Lucky Textile Industrial(Wuxi) Co.,Ltd. |
5. Device Description
The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
6. Intended Use/ Indications for Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
7. Technological characteristics comparison
| Comparison
item | Subject Device: Disposable
Surgical Mask(K203756) | Predicate Device: Single-
use Surgical Mask
(K200847) | Comments |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Product
Code | FXX | FXX | Same |
| Regulation
Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Use
(OTC/RX) | OTC | OTC | Same |
| Intended
Use & | When properly worn, the
surgical face masks are
intended to protect both
patient and healthcare
workers from transfer of
microorganisms, body fluids
and particulate materials.
This device is non sterile and
for single use only. | When properly worn, the
surgical face masks are
intended to protect both
patient and healthcare
workers from transfer of
microorganisms, body
fluids and airborne
particles. This device is
non-sterile and for
single use only. | Same |
| Comparison
item | Subject Device: Disposable
Surgical Mask (K203756) | Predicate Device: Single-
use Surgical Mask
(K200847) | Comments |
| Indications
for Use | When properly worn, the surgical face masks are
intended to protect both patient and healthcare
workers from transfer of microorganisms, body
fluids and particulate materials. This device is
non sterile and for single use only. | When properly worn, the surgical face masks are
intended to protect both patient and healthcare
workers from transfer of microorganisms, body
fluids and airborne particles. This device is
non-sterile and for single use only. | |
| Design
feature | 3 Ply, Ear Loops,
Flat-Pleated Style | 3 Ply, Ear Loops, Flat-
Pleated Style | Same |
| Usage | Single use | Single use | Same |
| Color | Blue | White | Different
Issue 1
Similar |
| Size | $9.5cm \pm 0.5cm$ (Width)
$17.5cm \pm 0.5cm$ (Length) | $9.0cm \pm 0.5cm$ (Width)
$17.5cm \pm 0.5cm$ (Length) | Issue 2 |
| Sterilization
Status | Non-sterile | Non-sterile | Same |
| Material | Outer layer:
Spun-bond polypropylene | Outer layer:
Spun-bond polypropylene | Same |
| | Middle layer:
Melt blown polypropylene
filter | Middle layer:
Melt blown polypropylene
filter | Same |
| | Inner layer:
Spun-bond polypropylene | Inner layer:
Spun-bond polypropylene | Same |
| | Nose piece:
Single Galvanize
Wire, Coated By PE | Nose piece:
Single Galvanize Wire,
Coated By PE | Same |
| Comparison
item | Subject Device: Disposable
Surgical Mask(K203756) | Predicate Device: Single-
use Surgical Mask
(K200847) | Comments |
| | Ear-Piece: Spandex | Ear-Piece: not made with
natural rubber latex | Same |
| ASTM F
2100 Level | Level 3 | Level 2 | Issue 3 |
| Fluid
Resistance
Performance
ASTM F
1862-13 | Lot 1: 32 Out of 32 pass at 160
mmHg
Lot 2: 32 Out of 32 pass at 160
mmHg
Lot 3: 32 Out of 32 pass at 160
mmHg | 30 Out of 32 pass at 120
mmHg | Different
Issue 4 |
| Particulate
Filtration
Efficiency
ASTM F
2299 | Lot 1:99.8%
Lot 2:99.9%
Lot 3: 99.9% | 99.9% | Same |
| Bacterial
Filtration
Efficiency
ASTM F
2101 | Lot 1: > 99.9%
Lot 2: > 99.9%
Lot 3: > 99.9% | > 99.9% | Same |
| Differential
Pressure
(Delta P) EN
14683:2019+
AC : 2019 | Lot 1: 3.4 mmH20/cm²
Lot 2: 3.5 mmH20/cm²
Lot 3: 3.3 mmH20/cm² | 3.0 mmH20/cm² | Same |
| Flammability
16CFR 1610 | Lot 1: Class 1
Lot 2: Class 1
Lot 3: Class 1 | Class 1 | Same |
| Cytotoxicity | Comply with ISO 10993-5
Non cytotoxic | Comply with ISO 10993-5
Non cytotoxic | Same |
| Irritation | Comply with ISO 10993-10
Non irritating | Comply with ISO 10993-
10
Non irritating | Same |
| Sensitization | Comply with ISO 10993-10
Non sensitizing | Comply with ISO 10993-
10
Non sensitizing | Same |
5
6
Discuss of Comments:
7
lssue 1: The composition of colorants are Phthalocyanine Blue BGS (CAS No.147-14-8) and Pigment Violet 23 (CAS No. 6358-30-1), we provided the MSDS of color additive used in our manufacturing process.
lssue 2: The width dimension of subject is a little longer than that of predicate device, this difference does not affect the safety and effectiveness.
lssue 3: Subject device comply with ASTM F 2100 Level 3, and we have done corresponding performance tests.
lssue 4:The test result of Fluid Resistance Performance meets the requirement of ASTM F 2100 Level 3.
8. Summary of Non-clinical Testing
Non-clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Standards: List as Applicable
- ASTM F2100-19 Standard Specification For Performance of Materials used in Medical Face Masks.
- ASTM F1862-13 Standard Test Method For Resistance of Medical Face Masks to Penetration by Synthetic Blood.
- ASTM F2299-03 Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR 1610 Standard For The Flammability Of Clothing Textiles.
- 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.
8
| Test Methodology | Purpose | Acceptance
Criteria | Results |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance
Performance
(ASTM F1862) | The test method is used to
evaluate the resistance of
medical face masks to
penetration by the impact of a
small volume(~2 mL) of high-
velocity stream of synthetic
blood. The pass/fail
determinations are based on
visual detection of synthetic
blood penetration. | 29 Out of 32 pass at
160 mmHg | Lot 1: 32 Out of 32
pass at 160 mmHg
Lot 2: 32 Out of 32
pass at 160 mmHg
Lot 3: 32 Out of 32
pass at 160 mmHg
Pass |
| Particulate Filtration
Efficiency
(ASTM F2299) | The purpose of this test
method is to measure the initial
partical filtration efficiency of
materials using monodispersed
aerosols containing suspended
latex spheres particulates of
0.1μm diameter. | ≥ 98% | Lot 1:99.8%
Lot 2:99.9%
Lot 3: 99.9%
Pass |
| Bacterial Filtration
Efficiency
(ASTM F2101) | The purpose of this test
method is to determine the
bacterial filtration efficiency of
the mask as specified in ASTM
F2101. | ≥ 98% | Lot 1: > 99.9%
Lot 2: > 99.9%
Lot 3: > 99.9%
Pass |
| Differential Pressure
(EN 14683:2019) | The purpose of this test s to
measure the differential
pressure between the inside
and outside of the mask. |