(45 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties and material composition of a standard surgical face mask. There is no mention of AI or ML in the intended use, device description, or performance evaluation.
No.
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, primarily for infection control. It is not designed to treat or prevent a specific disease or condition in a therapeutic manner.
No
This device, a surgical face mask, is intended for protection from transfer of microorganisms and fluids, not for the diagnosis of any medical condition. Its function is to provide a barrier.
No
The device description clearly outlines a physical product made of materials like polypropylene and aluminum wire, intended for physical protection. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. It's a physical barrier for infection control.
- Device Description: The description details the physical construction and materials of the mask.
- Performance Studies: The performance studies focus on the mask's barrier properties (filtration efficiency, resistance to penetration) and safety (biocompatibility, flame spread). These are all related to its function as a physical barrier.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This surgical face mask does not interact with or analyze any such specimens.
The device described is a surgical face mask, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The surgical face mask is green color, and Flat Pleated type mask, utilizing Tie-On way for wearing, and it has a Nose Piece design for fitting the facemask around the nose. 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 a melt-blown polypropylene filter. The model of the proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spunbond polypropylene. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The surgical face masks are sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Surgical Face Mask, non-sterile, tie on met all requirements of related international standards, including biocompatibility and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing:
Standards include:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks (Scope: Performance)
- ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) (Scope: Performance: Fluid Resistance Performance)
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus (Scope: Performance: Bacterial Filtration Efficiency (BFE))
- ASTM F2299-2003 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres (Scope: Performance: Particulate Filtration Efficiency (PFE))
- ASTM F2100-19 EN14683: 2019 Annex C (Scope: Performance: Differential Pressure (Delta P))
- 16 CFR 1610 (Scope: Performance: Flammability)
Biocompatibility:
Standards include:
- ISO10993-1:2009 Biological evaluation of medical devices--Part 1: Evaluation and testing (Scope: Biocompatibility)
- ISO10993-5:2009 Biological Evaluation of Medical Devices - Part 5 Tests for In Vitro Cytotoxicity. (Scope: Biocompatibility)
- ISO10993-10:2002/Amd. 1:2006(E) Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity (Scope: Biocompatibility)
Key Results:
All tests (BFE, PFE, Differential Pressure, Resistance to penetration by synthetic blood, Flame Spread) for the subject device showed "Pass" results, meeting or exceeding the acceptance criteria for a Level 2 Mask.
Biocompatibility tests (In Vitro Cytotoxicity, Skin Sensitization, Skin Irritation) also showed "Pass" results, indicating the device is non-cytotoxic, non-sensitizing, and non-irritating.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial Filtration Efficiency (BFE, %) ASTM F2101: ≥ 98% (Subject device), ≥ 98% (Acceptance Criteria for Level 2 Mask)
- Particulate Filtration Efficiency (PFE, at 0.1µm, %) ASTM F2299: ≥ 98% (Subject device), ≥ 98% (Acceptance Criteria for Level 2 Mask)
- Differential Pressure (Delta P, mm H2O/cm2) ASTM F2100-19 EN 14683:2019, Annex C:
§ 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.
0
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 25, 2020
Jiangxi 3L Medical Products Group Co., Ltd % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K202277
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 7, 2020 Received: T
Dear Charles Mack:
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.
1
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 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 (OS) 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 Elizabeth F. Claverie-Williams, MS 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
2
Indications for Use
510(k) Number (if known)
Device Name Surgical Face Mask
Indications for Use (Describe)
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a logo with the letters "3L" in a large, bold font in the center of a blue globe. The text "LOVE THE EARTH. LOVE THE PEACE. LOVE LIVES" is arranged around the top of the globe. Two olive branches are at the bottom of the globe, forming a semi-circle.
K202277 510(k) SUMMARY
| Preparation Date: | September 24, 2020 |
|---|---|
| Manufacturer's Name and Address: | Jiangxi 3L Medical Products Group Co., Ltd No.599, Huoju Street, High-tech Development Zone, Nanchang City, Jiangxi Province, China 330029 |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Surgical Face Mask |
| Common Name(s): | Surgical Face Mask |
| Regulation Name(s): | mask, surgical |
| Regulation Number(s): | 21CFR878.4040 |
| Product Code: | FXX |
| Device Class: | Class II |
| Predicate Device: | Xiantao Rayxin Medical Products Co., Ltd. Disposable Surgical Face Mask K153496 |
4
Device Description:
The surgical face mask is green color, and Flat Pleated type mask, utilizing Tie-On way for wearing, and it has a Nose Piece design for fitting the facemask around the nose. 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 a melt-blown polypropylene filter. The model of the proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spunbond polypropylene. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The surgical face masks are sold non-sterile and are intended to be single-use, disposable devices.
This product contains no components made with natural rubber latex.
Intended Use / Indications for Use
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The face mask is 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.
5
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device | Surgical Face Mask | Disposable Surgical Face Mask | N/A |
| Model | Tie on | Ear Loop and Tie-On | Identical |
| Manufacturer | JIANGXI 3L MEDICAL PRODUCTS GROUP | ||
| CO., LTD | Xiantao Rayxin Medical Products Co., Ltd. | N/A | |
| 510(k) | K202277 | K153496 | N/A |
| Indication for Use | The Surgical Face Mask is intended to be | ||
| worn to protect both the patient and | |||
| healthcare personnel from the transfer of | |||
| microorganisms, body fluids and particulate | |||
| material. The face mask is 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 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. | Identical | ||
| OTC or Prescription | OTC | OTC | Identical |
| Product Code | FXX | FXX | Identical |
| Classification | Class 2, CFR878.4040 | Class 2, CFR878.4040 | Identical |
| Material: | |||
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Identical |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Identical |
| Tie-on: | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Colorant | Polypropylene (PP) masterbatch | Polypropylene (PP) masterbatch | Identical |
| Design features | Color: Green | ||
| Tie on | Color: Blue | ||
| Tie on | The proposed device | ||
| and the predicate | |||
| devices are | |||
| biocompatible and | |||
| conform to ISO 10993 | |||
| series standards | |||
| Mask Style | Flat Pleated | Flat Pleated | Identical |
| Features | Subject Device | Predicate Device | Comparison |
| Specification | |||
| and Dimension | Length: 17.5cm±1cm | ||
| Width: 9.5cm±1cm | Length: 17.5cm±1cm | ||
| Width: 9.5cm±1cm | Identical | ||
| Sterility | Non-sterile | Non-sterile | Identical |
| Usage | Disposable, Single-Use | Disposable, Single-Use | Identical |
| Performance | |||
| Testing (ASTM F2100- |
-
| Level 2 | Level 2 | Identical |
| Fluid Resistance
Performance ASTM
F1862 | ≥ 120 mmHg | 32 out of 32 passes at 120mmHg | Meet ASTM F2100-19
Requirements for Level 2
Classification |
| Particulate Filtration
Efficiency ASTM
F2299 | ≥ 98% | Average 98.46% | Meet ASTM F2100-19
Requirements for Level 2
Classification |
| Bacterial Filtration
Efficiency ASTM
F2101 | ≥ 98% | Average 98.70% | Meet ASTM F2100-19
Requirements for Level 2
Classification |
| Differential Pressure
(Delta
P) EN 14683:2019,
Annex C | 3.0 mm H2O/cm² | 4.2 mm H2O/cm² | Meet ASTM F2100-19
Requirements for Level 2
Classification |
| Flammability 16 CFR
1610 | Class 1
Non-Flammable | Class 1
Non-Flammable | Identical |
| Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | Identical |
Comparison of Technological Characteristics with the Predicate Device
6
Discussion:
There is a little difference in performance test results and the predicate device. Both the submitted device and the predicate omply with the same performance standards. The minor differences in the technological characteristics do not raise and the subject device.
The proposed device and the predicate device are biocompatible and conform to the same ISO 10993 series standards.
Therefore, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.
7
Performance Testing
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Surgical Face Mask, non-sterile, tie on met all requirements of related international standards, including biocompatibility and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
Table of Conformity to Standards
| Standards | Scope |
|---|---|
| ASTM F2100-19 | |
| Standard Specification for Performance of Materials Used in Medical | |
| Face Masks | Performance |
| ASTM F1862/F1862M-17 | |
| Standard Test Method for Resistance of Medical Face Masks to | |
| Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at | |
| a Known Velocity | Performance: |
| Fluid Resistance | |
| Performance | |
| ASTM F2101-19 | |
| Standard Test Method for Evaluating the Bacterial Filtration Efficiency | |
| (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of | |
| Staphylococcus aureus | Performance: |
| Bacterial Filtration | |
| Efficiency (BFE) | |
| ASTM F2299-2003 | |
| Standard Test Method for Determining the Initial Efficiency of Materials | |
| Used in Medical Face Masks to Penetration by Particulates Using Latex | |
| Spheres | Performance: |
| Particulate Filtration | |
| Efficiency (PFE) | |
| ASTM F2100-19 | |
| EN14683: 2019 Annex C | Performance: |
| Differential Pressure | |
| (Delta P) | |
| 16 CFR 1610 | Performance: |
| Flammability | |
| ISO10993-1:2009 | |
| Biological evaluation of medical devices--Part 1: Evaluation and testing | Biocompatibility |
| ISO10993-5:2009 | |
| Biological Evaluation of Medical Devices - Part 5 Tests for In Vitro | |
| Cytotoxicity. | Biocompatibility |
| ISO10993-10:2002/Amd. 1:2006(E) | |
| Biological Evaluation of Medical Devices - Part 10: Tests for Irritation | |
| and Delayed-Type Hypersensitivity | Biocompatibility |
8
| Test | Subject device | Acceptance Criteria
for Level 2 Mask | Test Result |
|-------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------|-------------|
| Bacterial Filtration
Efficiency (BFE, %)
ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Particulate Filtration
Efficiency (PFE, at 0.1µm,
%) ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure
(Delta P, mm H2O/cm2)
ASTM F2100-19
EN 14683:2019, Annex C |