(110 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 described as a Disposable Surgical Face Mask intended for protection against the transfer of microorganisms, body fluids, and particulate material, primarily for infection control. It does not mention any therapeutic function.
No
The intended use of the device is to protect individuals from the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly outlines physical components (mask body, nose clip, ear loop) made of materials like nonwoven fabric, polyethylene, iron, nylon, and spandex. The performance studies also focus on physical properties and material testing, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical components and materials of the mask. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility). These are not metrics related to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
The device described is a surgical face mask, which is a type of personal protective equipment (PPE) used to prevent the spread of infection.
N/A
Intended Use / Indications for Use
The Disposable Surgical Face Mask 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. This a single use, disposable device(s), provided sterile and non-sterile.
Product codes
FXX
Device Description
The Disposable Surgical Face Masks are composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of polyethylene and iron material, ear loop is made of nylon and spandex material.
The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5%cm, the length of the ear loop is ≥ 10.0cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is 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 as was similar to the predicate device. 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 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 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);
- 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. Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- 16 CFR 1610, Standard for the Flammability of clothing textiles;
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance ASTM F1862: 32 out of 32 per lot pass at 160 mmHg, 3 non-consecutive lots tested for sterile and non-sterile. Acceptance Criteria: ASTM F2100 Level 3, 29 out of 32 pass at 160 mmHg for level 3. Result: PASS.
Particulate Filtration Efficiency ASTM F2299:
Lot1 before sterile:99.41%, Lot1 sterile: 99.50%, Lot1 after aging: 99.44%
Lot2 before sterile:99.36%, Lot2 sterile: 99.26%, Lot2 after aging:99.18%
Lot3 before sterile:99.36%, Lot3 sterile: 99.29%, Lot3 after aging:99.27%
Acceptance Criteria: ≥ 98%. Result: PASS.
Bacterial Filtration Efficiency ASTM F2101:
Lot1 before sterile: 99.77%, Lot1 sterile: 99.79%, Lot1 after aging:99.74%
Lot2 before sterile:99.80%, Lot2 sterile: 99.83%, Lot2 after aging: 99.77%
Lot3 before sterile:99.80%, Lot3 sterile: 99.78%, Lot3 after aging:99.76%
Acceptance Criteria: ≥ 98%. Result: PASS.
Differential Pressure EN 14683:
Lot1 before sterile: 4.52, Lot1 sterile: 4.52, Lot1 after aging:4.63
Lot2 before sterile: 4.51, Lot2 sterile: 4.54, Lot2 after aging:4.57
Lot3 before sterile:4.50, Lot3 sterile: 4.50, Lot3 after aging:4.53
Acceptance Criteria:
§ 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
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June 2, 2021
Jiangxi Heying Pharmaceutical Co., Ltd % Mandy Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, 200122 Cn
Re: K210429
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 8, 2021 Received: April 26, 2021
Dear Mandy Wu:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 mediation-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) K210429
Device Name Disposable Surgical Face Mask sterile and non-sterile
Indications for Use (Describe)
The Disposable Surgical Face Mask 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. This a single use, disposable device(s), provided sterile and non-sterile.
Type of Use (Select one or both, as applicable)
| Descriptive Use (Part 61 CFR 901 Subpart D) | |
|---|---|
| Over-The-Counter Use (61 CFR 901 Subpart C) |
_ | 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
4
Jiangxi Heying Pharmaceutical Co., Ltd Huangjinbu Town, Yugan County, Shangrao City, Jiangxi Province, 335100, CHINA
510(K) Summary
A. Applicant:
Name: Jiangxi Heying Pharmaceutical Co., Ltd Address: Huangjinbu Town, Yugan County, Shangrao City, Jiangxi Province, 335100, CHINA Contact Person: Junzheng Liu Tel: +86-793-3273758 Mail: 363047645@qq.com Date of summary prepared: 2021-05-28
Submission Correspondent: Primary contact: Ms. Mandy Wu Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: min.wu(@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: Disposable Surgical Face Mask Common Name: Surgical Face Mask Model(s): AE17.5×9.5cm
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K100846 IMC Surgical Face Mask (non-sterile and sterile, yellow) International Medsurg Connection
D. Indications for use of the device:
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 a single use,
5
Jiangxi Heying Pharmaceutical Co., Ltd
Huangjinbu Town, Yugan County, Shangrao City, Jiangxi Province, 335100, CHINA disposable device(s), provided sterile and non-sterile.
E. Device Description:
Table 1 General Comparison
The Disposable Surgical Face Masks are composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of polyethylene and iron material, ear loop is made of nylon and spandex material.
The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5%cm, the length of the ear loop is ≥ 10.0cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.
F. Technological Characteristic Comparison Table
| Device | Proposed Device | Predicate Device | Conclusion | |
|---|---|---|---|---|
| Manufacturer | Jiangxi Heying Pharmaceutical Co., Ltd | International Medsurg Connection | NA | |
| 510K number | K210429 | K100846 | NA | |
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | ||
| Indications for use | 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 a single use, disposable | ||||
| device(s), provided sterile | ||||
| and non-sterile. | This device is 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. | Similar | |||
| Material | Outer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middl | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose | Polyethylene and iron | NA | Different | |
| Ear | Nylon and spandex | NA | Different | |
| Color | Blue | Yellow | Different | |
| Dimension | 17.5+/-5%cm | 17.8cm (7 inches) | Similar | |
| Dimension | 9.5+/-5%cm | 8.9cm (3.5inches) | Similar | |
| OTC use | Yes | Yes | Same |
6
Jiangxi Heying Pharmaceutical Co., Ltd Huangiinbu Town, Yugan County, Shangrao City, Jiangxi Province, 335100, CHINA
| Sterility | Sterile& Non-Sterile | Sterile& Non-Sterile | Same |
|---|---|---|---|
| Sterilization Method | E.O. | Not available | Different |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 | Level 3 | Level 1,2,3 | Similar |
| Biocompatibility | ISO10993 | ISO10993 | Same |
| Fluid Resistance | 32 out of 32 per lot pass at 160 mmHg, | ||
| 3 non-consecutive lots tested for sterile | |||
| and non-sterile | Low=80 | ||
| Moderate=120 | |||
| High=160 | Similar | ||
| Particulate | |||
| Filtration | |||
| Efficiency | ≥98% | ≥98% | Similar |
| Bacterial | |||
| Filtration | |||
| Efficiency | ≥98% | Low≥95% | |
| Moderate≥98% | |||
| High≥98% | Similar | ||
| Differential | |||
| Pressure | 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
-
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- A 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. Stand 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;
Table 2 - Performance Testing
7
Jiangxi Heying Pharmaceutical Co., Ltd Huangjinbu Town, Yugan County, Shangrao City, Jiangxi Province, 335100,CHINA
| Test Methodology | Purpose: | Acceptance Criteria: | Result |
|---|---|---|---|
| Fluid Resistance | |||
| ASTM F1862 | The purpose of the performance testing is to demonstrate the functionality of the subject device. |
32 out of 32 per lot pass at 160 mmHg, 3 non-consecutive lots tested for sterile and non-sterile | ASTM F2100 Level 3
29 out of 32 pass at 160 mmHg for level 3 | PASS |
| Particulate
Filtration
Efficiency
ASTM
F2299 | Lot1 before sterile:99.41%
Lot1 sterile: 99.50%
Lot1 after aging: 99.44%
Lot2 before sterile:99.36%
Lot2 sterile: 99.26%
Lot2 after aging:99.18%
Lot3 before sterile:99.36%
Lot3 sterile: 99.29%
Lot3 after aging:99.27% | ≥ 98% | PASS |
| Bacterial
Filtration
Efficiency
ASTM
F2101 | Lot1 before sterile: 99.77%
Lot1 sterile: 99.79%
Lot1 after aging:99.74%
Lot2 before sterile:99.80%
Lot2 sterile: 99.83%
Lot2 after aging: 99.77%
Lot3 before sterile:99.80%
Lot3 sterile: 99.78%
Lot3 after aging:99.76% | ≥ 98% | PASS |
| Differential
Pressure
EN 14683 | Lot1 before sterile: 4.52
Lot1 sterile: 4.52
Lot1 after aging:4.63
Lot2 before sterile: 4.51
Lot2 sterile: 4.54
Lot2 after aging:4.57
Lot3 before sterile:4.50
Lot3 sterile: 4.50
Lot3 after aging:4.53 |