(100 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable medical mask, with no mention of AI or ML.
No.
The device is a medical mask intended for infection control by creating a physical barrier, not for treating a disease or condition.
No
Explanation: The device is a medical mask intended to protect against the transfer of microorganisms and fluids, not to diagnose a medical condition.
No
The device description clearly outlines a physical product made of materials like polypropylene and spandex, with physical components like ear loops and a nose clip. The performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose clip).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device itself does not perform any diagnostic test or analysis.
The device is a medical mask intended for infection control, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Disposable Medical 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.
Product codes
FXX
Device Description
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity>=2.8times; Breaking tension>=100N)
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly.
The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are 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
patient and 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
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same 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, Standard 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
| Test Methodology | Acceptance Criteria: ASTM F2100 Level 1 | Result |
|---|---|---|
| Fluid Resistance | 29 out of 32 per lot pass at 80 mmHg | Pass 32 out of 32 pass at 120 mmHg, 3 lots |
| Particulate Filtration Efficiency | >= 95% | Pass >98% |
| Bacterial Filtration Efficiency | >= 95% | Pass 99.9% |
| Differential Pressure |
§ 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 contains 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.
April 6, 2022
Hubei Wanli Protective Products Co. Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Company Limited. Room 1401, Dongfang Building, 1500# Century Avenue Shanghai 200122 China
Re: K214085
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 28, 2022 Received: March 1, 2022
Dear Ivy 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.
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,
Brent 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Disposable Medical Mask
Indications for Use (Describe)
The Disposable Medical 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.
] 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
Date of summary prepared: 2021-11-30 A. Applicant: Name: Hubei Wanli Protective Products Co., Itd. Address: Yuanshi, Ganhe, Xiantao, Hubei, China Contact: Andy Wen Title: System Specialist Tel: 0086-728-3227299 Email: sale01@hbwanli.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: Disposable Medical Mask Common Name: SURGICAL MASK Model: ear loops
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K210150 Disposable Medical Mask Hubei Wanli Protective Products Co., Itd.
4
D. Indications for use of the device:
The Disposable Medical 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.
E. Device Description:
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity≥2.8times; Breaking tension≥100N)
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly.
The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
F. Technological Characteristics Comparison Table
The proposed device is totally the same with the predicate device, only differ in the claim of ASTM LEVEL. Provided below is a comparison of the proposed device with the predicate device
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K210150 | - | |
| Manufacturer | Hubei Wanli Protective Products Co., ltd. | Hubei Wanli Protective Products Co., ltd. | - |
| Model Name | Disposable Medical Mask | Disposable Medical Mask | Same |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend use | The Disposable Medical 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. | The Disposable Medical 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. | Same |
| Design Features | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same |
Table 1 General Comparison
5
| Materials | | Outer
layer
facing | Non-woven Spun-bond
Polypropylene | Non-woven Spun-bond
Polypropylene | Same |
|--------------------------------------------------------|--|--------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------|
| | | Inner
layer
facing | Non-woven Spun-bond
Polypropylene | Non-woven Spun-bond
Polypropylene | Same |
| | | Filter layer | | Melt-blown Polypropylene | Melt-blown Polypropylene |
| | | Nose wire | | aluminum strip | aluminum strip |
| | | Ear loops | Spandex elastic | Spandex elastic | Same |
| Color | | | Blue | Blue | Same |
| Dimension (length) | | | 175mm±5mm | 175mm±5mm | Same |
| Dimension (width) | | | 95 mm±5mm | 95 mm±5mm | Same |
| OTC use | | | Yes | Yes | Same |
| Sterility | | | Non-Sterile | Non-Sterile | Same |
| Use | | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 Level | | | Level 1 | Level 2 | Different |
| Biocompatibility
(ISO10993) | | | Non-Cytotoxic, Non-Sensitizing,
Non-Irritating | Non-Cytotoxic, Non-Sensitizing,
Non-Irritating | Same |
| Fluid Resistance
Performance
ASTM F1862 | | | 32 out of 32 per lot pass at 120
mmHg, 3 non-consecutive lots
tested | 32 out of 32 per lot pass at 120
mmHg, 3 non-consecutive lots
tested | Same |
| Particulate
Filtration
Efficiency
ASTM F2299 | | | > 98% | > 98% | Same |
| Bacterial Filtration
Efficiency
ASTM F2101 | | | 99.9% | 99.9% | Same |
| Differential
Pressure (Delta P)
EN 14683 Annex C | | | ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
6
-
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;
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Standard 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;
| Test Methodology | Purpose | Acceptance Criteria:
ASTM F2100 Level 1 | Result |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------|
| Fluid Resistance | | 29 out of 32 per lot pass
at 80 mmHg | Pass
32 out of 32 pass at 120 mmHg, 3 lots |
| Particulate
Filtration Efficiency | The purpose of the
performance testing is to
demonstrate the
functionality of the subject
device. | $\ge 95%$ | Pass
98% |
| Bacterial Filtration
Efficiency | | $\ge 95%$ | Pass
99.9% |
| Differential
Pressure | | $