(191 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard disposable face mask, with no mention of AI or ML.
No.
The device description and intended use clearly state its purpose is to protect against the transfer of microorganisms, body fluids, and particulate material, not to provide therapy.
No
This device is described as a medical disposable face mask intended for protection from microorganisms, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, disposable face mask made of various materials (polypropylene, polyethylene wire) and includes performance testing related to physical properties (fluid resistance, filtration efficiency, flammability), 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 device is for protection (patient and healthcare personnel) from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of a face mask, designed to filter and block substances. There is no mention of components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the mask related to its barrier function (fluid resistance, filtration efficiency, breathability, flammability). These are not diagnostic performance metrics.
- No Mention of Biological Samples or Analysis: There is no indication that this device interacts with or analyzes biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This face mask does not fit that description.
N/A
Intended Use / Indications for Use
The device 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 is a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The Medical disposable face mask non sterile is single use, three-layer, flat-folded masks with ear loops and nose piece. The Medical disposable face mask non sterile is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The outer non-woven cloth is blue and is dyed by colorant of Reactive Blue 2, and the inner non-woven cloth is white and is not dyed by colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Medical disposable face mask non sterile will be provided in blue. The Medical disposable face mask non sterile is 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)
The proposed devices were tested and conformed to 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.
Performance testing:
- Fluid Resistance ASTM F1862: 3 batches, synthetic blood penetration of 32 test articles per each batch is none seen at 120mmHg test pressure.
- Particulate Filtration Efficiency ASTM F2299: 3 batches, average PFE of 32 test articles per each batch: >99.986%, >99.986%, >99.982%; standard deviation: 0.0123, 0.0142, 0.0389.
- Bacterial Filtration Efficiency ASTM F2101: 3 batches, BFE of 32 test articles per each batch: >99.9%, >99.9%, >99.9%.
- Differential Pressure (Delta P) EN 14683:2019+AC:2019 Annex C, Flow rate 8 L/min: 3 batches, Delta P of 32 test articles per each batch: 2.7-3.2 mmH2O/cm², 2.7-2.9 mmH2O/cm², 2.6-3.0mmH2O/cm².
- Flammability 16 CFR 1610: Class 1, 3 batches, 32 test articles per each batch are ignited, but extinguished.
Biocompatibility testing:
- Cytotoxicity: Under the conditions of the study, the device is non-cytotoxic (Pass).
- Irritation: Under the conditions of the study, the device is non-irritating (Pass).
- Sensitization: Under the conditions of the study, the device is non-sensitizing (Pass).
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance ASTM F1862: 32 out of 32 pass at 120mmHg
- Particulate Filtration Efficiency ASTM F2299: >99.986%, >99.986%, >99.982%; standard deviation: 0.0123, 0.0142, 0.0389
- Bacterial Filtration Efficiency ASTM F2101: >99.9%, >99.9%, >99.9%
- Differential Pressure (Delta P) EN 14683:2019+AC:2019 Annex C, Flow rate 8 L/min: 2.7-3.2 mmH2O/cm², 2.7-2.9 mmH2O/cm², 2.6-3.0mmH2O/cm²
- Flammability 16 CFR 1610: Class 1
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.
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 24, 2021
Guangdong Zhong Ling Industrial Group Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, Guangdong 511660 China
Re: K202650
Trade/Device Name: Medical disposable face mask non sterile Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 4, 2021 Received: January 4, 2021
Dear Jinghua Zhou:
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 CAPT Elizabeth Claverie, M.S. 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) K202650
Device Name Medical disposable face mask non sterile
Indications for Use (Describe)
The device 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 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)
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
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
K202650
Date of Summary Preparation: March 5, 2021
1. Submitter's Identifications
Submitter's Name: Guangdong Zhong Ling Industrial Group Co., Ltd. Address: Room 101, Building 1, No. 5, Shengfeng Road, Xinhe Wanjiang, Dongguan, Guangdong, China Zip Code: 523045 Contact Person: Ann Ho Contact Title: Chief Financial Officer Contact E-mail Address: ann@dgzhongling.com Telephone: +86-769-22175828 Fax: +86-769-22175838
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Mask, Surgical Regulation Description: Surgical apparel Trade Name: Medical disposable face mask non sterile Model: ZL-0001 Regulation Medical Specialty: General & Plastic Surgery Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Device Classification: Class II
4. The Predicate Devices
Surgical Face Mask, Model: Ear Loop K182515 Wuhan Dymex Healthcare Co., Ltd
4
5. Device Description
The Medical disposable face mask non sterile is single use, three-layer, flat-folded masks with ear loops and nose piece. The Medical disposable face mask non sterile is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The outer non-woven cloth is blue and is dyed by colorant of Reactive Blue 2, and the inner non-woven cloth is white and is not dyed by colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Medical disposable face mask non sterile will be provided in blue. The Medical disposable face mask non sterile is sold non-sterile and are intended to be single use, disposable devices.
6. Indications for use
The device 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 is a single use, disposable device(s), provided non-sterile.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Proposed Device | Predicate device | Comparison | ||
|---|---|---|---|---|
| 510k Number | K202650 | K182515 | ||
| Product Code | FXX | FXX | Same | |
| Proprietary Name | Medical disposable | |||
| face mask non sterile | Surgical Face Mask | |||
| Model | ZL-0001 | Ear Loop | ||
| Manufacturer | Guangdong Zhong | |||
| Ling Industrial | ||||
| Group Co., Ltd. | Wuhan Dymex | |||
| Healthcare Co., Ltd | ||||
| Indications for Use | The device is | |||
| intended to be worn | ||||
| to protect both the | ||||
| patient and | ||||
| healthcare personnel | ||||
| from transfer of | ||||
| microorganisms, | ||||
| body fluids and | The Surgical Face | |||
| Masks are intended | ||||
| to be worn to protect | ||||
| both the patient and | ||||
| healthcare personnel | ||||
| from transfer of | ||||
| microorganisms, | ||||
| body fluids and | Same | |||
| 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. | 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. | ||||
| Type of Use | Over-the-counter | Over-the-counter | Same | |
| Structure | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same | |
| Outer | ||||
| facing | ||||
| layer | Spun-bond | |||
| polypropylene | Spun-bond | |||
| polypropylene | Same | |||
| Middle | ||||
| layer | Melt blown | |||
| polypropylene filter | Melt blown | |||
| polypropylene filter | Same | |||
| Materials | Inner | |||
| facing | ||||
| layer | Spun-bond | |||
| polypropylene | Spun-bond | |||
| polypropylene | Same | |||
| Nose | ||||
| piece | Malleable | |||
| polyethylene wire | Malleable | |||
| polyethylene wire | Same | |||
| Ear | ||||
| loops | Spandex | Spandex | Same | |
| Color | Blue | Yellow | Different1 | |
| Dimension | $175mm \times 95mm$ | $17.5cm \times 9.5cm (\pm 0.2cm)$ | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single Use, | |||
| Disposable | Single Use, | |||
| Disposable | Same | |||
| Fluid Resistance | ||||
| Performance | ||||
| ASTM F1862 | 3 batches, synthetic blood penetration of 32 test articles per each batch is none seen at 120mmHg test pressure | 32 out of 32 pass at 120mmHg | Same | |
| Particulate | ||||
| Filtration | ||||
| Efficiency ASTM | ||||
| F2299 | 3 batches, | |||
| average PFE of 32 | ||||
| test articles per each | ||||
| batch: |
99.986%,
99.986%,
99.982%;
standard deviation:
0.0123,
0.0142,
0.0389 | 99.7% | Same | |
| Bacterial Filtration
Efficiency ASTM
F2101 | 3 batches,
BFE of 32 test
articles per each
batch:
99.9%,
99.9%,
99.9% | 99.9% | Same | |
| Differential
Pressure (Delta P)
EN
14683:2019+AC:20
19 Annex C, Flow
rate 8 L/min | 3 batches,
Delta P of 32 test
articles per each
batch:
2.7-3.2 mmH2O/cm²,
2.7-2.9 mmH2O/cm²,
2.6-3.0mmH2O/cm² | 4.0mmH2O/cm² | Same | |
| Flammability 16
CFR 1610 | Class 1
3 batches, 32 test
articles per each
batch are ignited, but
extinguished | Class 1
Non Flammable | Same | |
| Cytotoxicity | Under the conditions
of the study, the
device is
non-cytotoxic | Under the conditions
of the study, the
device is
non-cytotoxic | Same | |
| Irritation | Under the conditions
of the study, the
device is non-
irritating | Under the conditions
of the study, the
device is non-
irritating | Same | |
| Sensitization | Under the conditions
of the study, the
device is
non-sensitizing | Under the conditions
of the study, the
device is
non-sensitizing | Same | |
| Standard | ASTM F2100-19
ISO10993-1 | ASTM F2100-19
ISO10993-1 | Same | |
Table 1 Comparison to Predicate Device
5
6
7
Guangdong Zhong Ling Industrial Group Co., Ltd.
| ISO10993-5
ISO10993-10 | ISO10993-5
ISO10993-10 | |
| --------------------------- | --------------------------- | -- |
|---|
8. Justification of differences
Note 1: Our device and the predicate device are almost identical in terms of all areas described in the above table (Table 1). The difference in the colors does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
9. Summary of Non-Clinical Testing:
The proposed devices were tested and conformed to 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.
| Item | Proposed device1 | Acceptance Criteria | Results |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 32 out of 32 pass at 120mmHg | 29 out of 32 pass at 120mmHg | 3 batches, synthetic blood penetration of 32 test articles per each batch is none seen at 120mmHg test pressure |
| Particulate Filtration Efficiency ASTM F2299 | Level 2≥ 98% | Level 2≥ 98% | 3 batches, average PFE of 32 test articles per each batch: |
99.986%,
99.986%,
99.982%;
standard deviation:
0.0123,
0.0142,
0.0389 |
| Bacterial Filtration Efficiency ASTM F2101 | Level 2≥ 98% | Level 2≥ 98% | 3 batches, BFE of 32 test articles per each batch:
99.9%,
99.9%,
99.9% |
Table 2 Performance testing
8
| Differential Pressure
(Delta P) EN
14683:2019+AC:2019
Annex C, Flow rate 8
L/min | Level 2