(77 days)
Not Found
No
The device description and testing focus solely on the physical properties and performance of a surgical face mask, with no mention of AI or ML capabilities.
No
A surgical mask is a protective barrier designed to prevent the transfer of microorganisms and fluids, not to provide therapeutic treatment or achieve a therapeutic effect.
No
Explanation: The provided text explicitly states the device is a "Surgical Face Mask," intended for protection and infection control by acting as a barrier. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly outlines the physical components of a surgical face mask made of various materials (polypropylene, nylon, spandex, galvanized iron wire coated by PE), indicating it is a hardware device.
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 by being worn on the face. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Testing: The testing described focuses on the physical performance of the mask (filtration efficiency, fluid resistance, flammability) and biocompatibility (cytotoxicity, irritation, sensitization). These are not tests related to diagnosing a condition or analyzing a biological sample.
- Lack of IVD Characteristics: IVD devices typically involve analyzing samples like blood, urine, tissue, etc., to detect or measure specific substances or characteristics for diagnostic purposes. This mask does not perform any such analysis.
The device is a surgical face mask, which is a type of medical device used for infection control, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Surgical Face Mask (Non-sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.
The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.
The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
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 specification. 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 Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
- A ISO 10993-05:2009 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
- 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)
- A 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 Latex Spheres
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles
Performance testing and biocompatibility testing results:
- Bacterial Filtration Efficiency ASTM F2101: Measure bacterial filtration efficiency. Acceptance Criteria for Level 3 Barrier: >=98%. Result: Passed (3 non-consecutive lots tested, using a sample size of 32/lot; Lot 1: >=98%, Lot 2: >=98%, Lot 3: >=98%).
- Differential Pressure (mmH2O/cm squared) EN 14683:2019 Annex C: Determine breathability of the mask. Acceptance Criteria for Level 3 Barrier: =98%. Result: Passed (3 non-consecutive lots tested, using a sample size of 32/lot; Lot 1: >=98%, Lot 2: >=98%, Lot 3: >=98%).
- Resistance to Penetration by Synthetic Blood ASTM F1862-17: Evaluate the resistance to penetration by impact of small volume of synthetic blood. Acceptance Criteria for Level 3 Barrier: 29 out of 32 pass at 160 mmHg. Result: Passed (3 non-consecutive lots tested, using a sample size of 32/lot; 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).
- Flammability 16 CFR Part 1610-2008: Response of materials to heat and flame. Acceptance Criteria for Level 3 Barrier: Class I. Result: Passed (3 non-consecutive lots tested, using a sample size of 32/lot; Lot 1: Class 1, Lot 2: Class 1, Lot 3: Class 1).
- Cytotoxicity: Assess the potential risk of cytotoxicity of mask material. Acceptance Criteria for Level 3 Barrier: Non-cytotoxic. Result: Pass (Under the condition of this study, the device has no potential toxicity).
- Irritation: Assess the potential risk of irritation of mask material. Acceptance Criteria for Level 3 Barrier: Negligibly irritating. Result: Under the condition of this study, the device is negligibly irritating.
- Sensitization: Assess the potential risk of sensitization of mask material. Acceptance Criteria for Level 3 Barrier: Non-sensitizing. Result: Under the conditions of the study, the device is non-sensitizing.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for test results related to Bacterial Filtration Efficiency, Particulate Filtration Efficiency, and Synthetic Blood Penetration Resistance.
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 20, 2022
Xiantao Junhui Plastic Products Co., Ltd. % Ms. Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co., Ltd. 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K221976
Trade/Device Name: Surgical Face Mask (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 5, 2022 Received: July 5, 2022
Dear Ms. Wang:
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 (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 Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Surgical Face Mask (Non-sterile)
Indications for Use (Describe)
The Surgical Face Mask (Non-sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This 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)
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3
510(K) Summary
(As requirement by 21 CFR 807.92)
Date prepared: 15th, June, 2022
A. Applicant:
Name: XIANTAO JUNHUI PLASTIC PRODUCTS CO., LTD. Address: No. 3, Babu Industrial Park, Pengchang Town, Xiantao City, HUBEI, CHINA Contact: Fiona Tian Title: Sales Manager Tel: +86-15027285720 Email: fiona@xtjhslzp.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Surgical Face Mask (Non-sterile) Model: Flat type/over-the-ear
Regulatory Information Common Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation: 21 CFR 878.4040 - Surgical apparel
C. Identification of Primary Predicate device:
K211827 Zhejiang Lanhine Medical Products LTD. Trade Name: Level 3 Fluid Resistant Procedure/Surgical Mask Common Name: Surgical Face Mask Model(s): 15604F, 15704F
4
XIANTAO JUNHUI PLASTIC PRODUCTS CO., LTD. No. 3, Babu Industrial Park, Pengchang Town, Xiantao City, HUBEI, CHINA
Regulatory Information: Common Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation: 21 CFR 878.4040 - Surgical apparel
D. Indications for use of the device:
The Surgical Face Mask (Non-sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.
The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.
The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
F. Comparison of technological characteristics with the predicate device
The Surgical Face Masks are essentially the same as or similar to the predicate device in terms of the indications for use, design and construction, performance characteristics. Provided below table 1 is a comparison of the proposed device with the predicate device.
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | - | K211827 | - |
| Manufacturer | XIANTAO JUNHUI PLASTIC | ||
| PRODUCTS CO., LTD. | Zhejiang Lanhine Medical Products LTD. | - | |
| Product Name | Surgical Face Mask (Non-sterile) | Level 3 Fluid Resistant | |
| Procedure/Surgical Mask | Similar | ||
| Level | Level 3 | Level 3 | Same |
Table 1 Comparison of Proposed and Predicate Devices
5
XIANTAO JUNHUI PLASTIC PRODUCTS CO., LTD. No. 3, Babu Industrial Park, Pengchang Town, Xiantao City, HUBEI, CHINA
| Product Code | FXX | FXX | Same |
|---|---|---|---|
| Regulation | |||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications | |||
| for | |||
| use | The Surgical Face Mask (Non-sterile) is | ||
| intended to be worn to protect both the | |||
| patient and healthcare personnel from | |||
| transfer of microorganisms, body fluids | |||
| and particulate material. The Surgical Face | |||
| Mask is intended for use in infection | |||
| control practices to reduce the potential | |||
| exposure to blood and body fluids. This a | |||
| single use, disposable device(s), provided | |||
| non-sterile. | The Level 3 Fluid Resistant | ||
| Procedure/Surgical Masks (model: | |||
| 15604F, 15704F) 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 | |||
| a single use, disposable device(s), | |||
| provided non-sterile. | Same | ||
| Design Feature | Ear loops, flat pleated, 3 layers | Ear loops, tie-on, flat pleated, 3 layers | Similar |
| Color | Blue | Blue | Same |
| Dimension | $175 \pm 5mm$ | ||
| $95 \pm 5mm$ | $17.5cm \pm 0.5cm$ | ||
| $9.5cm \pm 0.5cm$ | Same | ||
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Material | |||
| Outer layer | Spun-bonded non-woven fabric | ||
| (polypropylene) | Non-woven fabric | ||
| (Polypropylene) | Same | ||
| Middle layer | Polypropylene melt-blown non-woven | ||
| fabric | Melton blown fabric | ||
| (Polypropylene) | Same | ||
| Inner layer | Spun-bonded non-woven fabric | ||
| (polypropylene) | Non-woven fabric | ||
| (Polypropylene) | Same | ||
| Nose clip | Galvanized iron wire coated by PE | Polypropylene coating iron | Different |
| Ear loops | Nylon and spandex | Polyurethane | Different |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
Difference Analysis:
The proposed device has same intended use, structure, parameter and performance with the predicate device. The materials of inner layer, middle layer and outer layer of the proposed device are also the same as those of the predicate device.
The proposed device has different material of nose clip and ear loops to the predicate device. However, biocompatibility test has been performed on the proposed device according to ISO 10993-10 and the results does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
6
G. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. 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 Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
- A ISO 10993-05:2009 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
-
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)
- A 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 Latex Spheres
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles
Performance testing and biocompatibility testing are summarized in below table 2.
| Test Methodology | Purpose | Acceptance Criteria
for Level 3 Barrier | Result |
|---------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Bacterial Filtration
Efficiency
ASTM F2101 | Measure bacterial
filtration efficiency | ≥98% | Passed
3 non-consecutive lots tested, using a
sample size of 32/lot
Lot 1: ≥98%
Lot 2:≥98%
Lot 3:≥98% |
| Differential
Pressure
(mmH2O/cm²)
EN 14683:2019
Annex C | Determine
breathability of the
mask |