(216 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard medical face mask. There is no mention of AI or ML in the document.
No.
The device description states its purpose is to protect from the transfer of microorganisms, body fluids, and particulate material, which is a barrier function, not a therapeutic one.
No
Explanation: The device is a medical face mask, intended to protect users from the transfer of microorganisms, body fluids, and particulate material. Its function is protective, not diagnostic.
No
The device description clearly outlines a physical, disposable medical face mask made of various materials (spun-bond non-woven fabric, melt blown polypropylene filter, spandex elastic bands, aluminum wire). The performance studies focus on physical properties and biological interactions, not software functionality.
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 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 in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose piece). This aligns with a personal protective equipment (PPE) device, not an IVD.
- Performance Studies: The performance studies focus on the mask's barrier properties (filtration efficiency, fluid resistance), breathability (differential pressure), flammability, and biocompatibility (cytotoxicity, irritation, sensitization). These are all relevant to a medical mask's function as a physical barrier and for user safety, not for diagnosing a condition.
- Key Metrics: The key metrics measured (BFE, Delta-P, PFE, etc.) are all related to the physical performance and safety of the mask as a barrier. They are not metrics associated with the accuracy or performance of a diagnostic test.
- Predicate Device: The predicate device listed is a "Surgical Mask," which is a type of medical device used for protection, not for diagnosis.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The disposable medical 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 masks are 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 disposable medical face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm.
The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask 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
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 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:
- ASTM F2299-03, Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- EN 14683:2019,Annex C.Method for determination of breathability (differential pressure)
- ASTM F1862/ASTM F1862M-17, Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 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.
Performance Testing Results:
- Bacterial filtration efficiency (BFE) ASTM F2101-19: Lot A: 99.9%, Lot B: 99.9%, Lot C: 99.9%. Acceptance criteria: BFE≥98%. Verdict: Pass.
- Differential pressure, (Delta-P) EN 14683:2019, Annex C: Lot A: 2.24mmH2O/cm², Lot B: 2.17mmH2O/cm², Lot C: 2.07mmH2O/cm². Acceptance criteria: Delta-P
§ 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.
January 16, 2022
Zhejiang The Purples Protective Products Co.,Ltd % Doris Chen Staff Shanghai Jiushun Enterprise Management Technology Service Co., Ltd. Room 1502, BaoAn Building, No.800 Dongfang Road Shanghai, 200122 China
Re: K211833
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 17, 2021 Received: December 22, 2021
Dear Doris Chen:
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 (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 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) K211833
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The disposable medical 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 masks are 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Chapter 5. 510(k) Summary
510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR
807.92.
The assigned 510(k) Number:K211833
Summary Prepared Date:December 17, 2021
1. Applicant :
Sponsor Name: Zhejiang The Purples Protective Products Co.,Ltd
Address:No.45, Suhua Street, Suxi Town, Yiwu City, Zhejiang Province, China.
Contact Person (including title): Lihui Jiang (Manager)
Phone:+86-579-85178961
2. Submission Correspondent:
Contact Person: Doris Chen
Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
Address: Room 1502,BaoAn Buiding,No.800 Dongfang Road,Shanghai,China.
Tel: +86-21-50931939
Email: doris-chen@isosh.com
3. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Face Mask |
| Trade Name: | Disposable Medical Face Mask |
| Classification Name: | Mask,Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
4
Predicate Device Information 4.
Predicate Device
| Sponsor: | Foshan Xinbao Technology Co., Ltd |
|---|---|
| Common Name: | Surgical apparel |
| Trade Name: | Surgical Mask |
| 510(k) number: | K202424 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
5. Device Description
The disposable medical face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm.
The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask are sold non-sterile and are intended to be single use,disposable devices.
5
Intended Use / Indications for Use 6.
The disposable medical 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 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.
7. Comparison with predicate device
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Zhejiang The Purples | ||
| Protective Products Co.,Ltd | Foshan Xinbao Technology | ||
| Co., Ltd. | -- | ||
| Product Name | Disposable Medical Face | ||
| Mask | Surgical Mask | -- | |
| K Number | K211833 | K202424 | -- |
| Product Code | FXX | FXX | Same |
| Regulation | |||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Intended use/ | |||
| Indications for Use | The disposable medical mask | ||
| are intended to be worn to | |||
| protect both the patient and | |||
| healthcare personnel from | |||
| transfer of microorganisms, | |||
| body fluids and particulate | |||
| material. These 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 Surgical Masks are | ||
| intended to be worn to | |||
| protect both the patient | |||
| and healthcare personnel | |||
| from transfer of | |||
| microorganisms, body | |||
| fluids, and particulate | |||
| material. These masks are | |||
| intended for use in | |||
| infection control practices to | |||
| reduce potential exposure | |||
| to blood and body fluids. | |||
| This is a single use, | |||
| disposable device, provided | |||
| nonsterile. | Same | ||
| Mask style | Flat pleated, 3 layers. | Flat pleated,3 layers. | Same |
| Design feature | Ear loop | Ear loop | Same |
Table 1 General Comparison
6
| | Material | Outer
facing
layer | Spun-bond non-woven fabric | Spun-bond polypropylene | | Similar
Note 1 | |
|---------------|----------|------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------|---------------------------|-------------------|
| | | Middle
layer | Melt blown polypropylene filter | Melt blown polypropylene | | Same | |
| | | Inner
facing
layer | Spun-bond non-woven fabric | Spun-bond polypropylene | | Similar
Note 1 | |
| | | Nose
piece | Malleable aluminum wire | Galvanized iron wire | | Different
Note 1 | |
| | | Ear
loops | Spandex | Nylon and Spandex | | Different
Note 1 | |
| | | Color | Blue | Blue | | Same | |
| | | Dimension (Width) | 17.5cm±1cm | 17.5cm±1cm | | Same | |
| | | Dimension
(Length) | 9.5cm±1cm | 9.5cm±1cm | | Same | |
| | | OTC use | Yes | Yes | | Same | |
| | | Sterility | Non-Sterile | Non-Sterile | | Same | |
| | | Use | Single Use, Disposable | Single Use, Disposable | | Same | |
| ASTM
F2100 | | Level | Level 2 | Level 3 | | Same | |
| | | | 3non-consecutive lots tested,
using a sample size of 32/lot. | | Level 2 | Level 3 | |
| | | Fluid resistance
Performance
ASTM F1862 | 32 out of 32
pass at
120mmHg | 32 out of 32
pass at
160mmHg | Pass at 120
mmHg | Pass at 160
mmHg | Same |
| | | Particle Filtration
Efficiency
ASTM F2299 | Lot A: 99.9%
Lot B: 99.9%
Lot C:99.9% | Lot A: 99.9%
Lot B: 99.9%
Lot C: 99.9% | Pass at
≥98% | Pass at
≥98% | Similar
Note 2 |
| | | Bacterial Filtration
Efficiency
ASTM F2101 | Lot A: 99.9%
Lot B: 99.9%
Lot C:99.9% | Lot A: 99.9%
Lot B: 99.9%
Lot C:99.9% | Pass at
≥98% | Pass at
≥98% | Similar
Note 2 |
| | | Flammability
Class
16 CFR 1610 | Class 1 | Class 1 | Class 1 | Class 1 | Same |
| | | Differential
Pressure
(Delta -P)
EN 14683 Annex C | Lot A:
2.24mmH2O/cm²
Lot B:
2.17mmH2O/cm²
Lot C:
2.07mmH2O/cm² | Lot A:
2.24mmH2O/cm²
Lot B:
2.17mmH2O/cm²
Lot C:
2.07mmH2O/cm² | Pass at EN 14683:2019,Annex C.Method for determination of breathability (differential pressure)
8
- ASTM F1862/ASTM F1862M-17, Standard test method for resistance of Surgical face A masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
-
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
-
16 CFR Part 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.
Table 2:Performance Testing
| Test item
(Performance | Proposed device | | Acceptance criteria | | Test
results
/Verdict |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------|------------------------|-----------------------------|
| Level 2/Level 3) | Level 2 | Level 3 | Level 2 | Level 3 | |
| Bacterial filtration
efficiency (BFE)
ASTM F2101-19 | Lot A: 99.9%
Lot B: 99.9%
Lot C:99.9% | Lot A: 99.9%
Lot B: 99.9%
Lot C:99.9% | BFE≥98%. | BFE≥98%. | Pass |
| Differential
pressure, (Delta-P)
EN 14683:2019,
Annex C | Lot A:
2.24mmH2O/cm²
Lot B:
2.17mmH2O/cm²
Lot C:
2.07mmH2O/cm² | Lot A:
2.24mmH2O/cm²
Lot B:
2.17mmH2O/cm²
Lot C:
2.07mmH2O/cm² | Delta-P Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices
—Part 10: Tests for irritation and skin sensitization
- A Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices-
Part 10: Tests for irritation and skin sensitization.
| Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is | |
| noncytotoxic. | Pass | |
| Irritation | Under the conditions of the study, the device is | |
| nonirritating. | Pass | |
| Sensitization | Under the conditions of the study, the device is | |
| nonsensitizing | Pass |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device,
Disposable Medical Face Mask is as safe, as effective, and performs as well as or better than
the legally marketed predicate device, Surgical Mask (K202424).