(270 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a medical mask, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a mask intended to protect against the transfer of microorganisms and fluids, which is a preventive measure, not a treatment.
No
Explanation: The device is a Disposable Medical Mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its purpose is to reduce exposure, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (mask body, nose piece, ear loops/ties) made of various materials (polypropylene, galvanized iron wire, polyester, spandex). The performance studies also focus on physical properties like filtration, breathability, and flammability, which are characteristic of hardware devices.
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 components and materials of the mask. There is no mention of reagents, assays, or any components typically associated with diagnostic testing.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, breathability, and safety (flammability, biocompatibility). These are not studies evaluating the accuracy or performance of a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
N/A
Intended Use / Indications for Use
Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 as sterile.
Product codes
FXX
Device Description
The Disposable Medical Mask consists of a mask body, a nose piece, and ear loops or ties.
The mask body is divided into four layers, the inner, second and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of galvanized iron wire, the ear loops are made of polyester and spandex, and the ties are made of polypropylene.
The Medical Surgical Mask will be provided in green. The Disposable Medical Mask is sold as sterile and are intended to be single use, disposable devices.
The size specification of the surgical mask:
-
Mask body for ear-loop type: 14.5cm × 9cm (S), 17.5cm × 9.5cm (M), 18cm × 9.3cm (L), 22cm×9.5cm (XL);
-
Mask body for Tie-on type: 14.5cm X 9cm (S), 17.5cm X 9.5cm (M), 18cm X 9.3cm (L), 22cm×9.5cm (XL).
The smallest sizes mask (14.5cm×9cm) are for adult population only.
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
The smallest sizes mask (14.5cm×9cm) are for adult population only.
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 Test Conclusion:
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Tests performed:
- 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)
- 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 Results:
- Synthetic Blood Penetration (ASTM F1862): 32 out of 32 samples pass at 160 mmHg.
- Particulate Filtration Efficiency (ASTM F2299): Filtration Efficiency (%) ≥ 99.80%.
- Bacterial Filtration Efficiency (ASTM F2101): Percent BFE (%) ≥ 99.80%.
- Differential Pressure (Delta P) (EN 14683 Annex C): Average 4.2 mm H2O/cm².
- Flammability (16 CFR 1610): Class I.
- Cytotoxicity: The subject device was non-cytotoxic.
- Irritation: The subject device was non-irritating.
- Sensitization: The subject device was non-sensitizing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Particulate Filtration Efficiency (ASTM F2299): Filtration Efficiency (%) ≥ 99.80%
- Bacterial Filtration Efficiency (ASTM F2101): Percent BFE (%) ≥ 99.80%
- Differential Pressure (Delta P) (EN 14683 Annex C): Average 4.2 mm H2O/cm²
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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May 19, 2023
Guangzhou Fuzelong Hygiene Material Co., Ltd % Boyle Wang Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K222545
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: April 1, 2023 Received: April 19, 2023
Dear Boyle 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 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,
Katherine D. Kavlock -S
for
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
Indications for Use
510(k) Number (if known) K222545
Device Name Disposable Medical Mask
Indications for Use (Describe)
Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 as 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
K222545
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 submitter's Information
Name: Guangzhou Fuzelong Hygiene Material Co., Ltd Address: #12, Guancun Road, Jiangpu Street, Conghua, Guangzhou, China 510900 Tel:+86-020-87993188 Contact: Haiyan Zeng Date of Preparation: Aug.12, 2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai 200120, China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Medical Mask Common name: Surgical Face Mask Classification name: Surgical Face Mask Model: Ear loops, Tie-on
3.0 Classification
FXX - Mask, Surgical. Production code: Classification Name: Surgical Apparel (21 CFR part 878.4040) Classification: Class II Panel: Surgical Apparel
4.0 Predicate Device Information
Manufacturer: | Jiangsu Xingtong Biotechnology Group Co., Ltd. |
---|---|
Device: | Surgical mask |
510(k) number: | K211454 |
4
5.0 Device Description
The Disposable Medical Mask consists of a mask body, a nose piece, and ear loops or ties.
The mask body is divided into four layers, the inner, second and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of galvanized iron wire, the ear loops are made of polyester and spandex, and the ties are made of polypropylene.
The Medical Surgical Mask will be provided in green. The Disposable Medical Mask is sold as sterile and are intended to be single use, disposable devices.
The size specification of the surgical mask:
-
Mask body for ear-loop type: 14.5cm × 9cm (S), 17.5cm × 9.5cm (M), 18cm × 9.3cm (L), 22cm×9.5cm (XL);
-
Mask body for Tie-on type: 14.5cm X 9cm (S), 17.5cm X 9.5cm (M), 18cm X 9.3cm (L), 22cm×9.5cm (XL).
The smallest sizes mask (14.5cm×9cm) are for adult population only.
6.0 Indication for Use Statement
Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 as sterile.
7.0 Comparison to the Predicate Device
Table 1 General Comparison | ||||
---|---|---|---|---|
Item | Subject Device | Predicate Device | ||
K211454 | Remark | |||
Product Name | Medical Surgical Mask | Surgical mask | -- | |
Product Code | FXX | FXX | Same | |
Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
Class | II | II | Same | |
Intended Use& | ||||
Indications for use | Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the | 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 face masks are intended for use in infection control practices to | Same | |
potential exposure to blood | ||||
and body fluids. This is a | ||||
single use, disposable | ||||
device(s), provided as | ||||
sterile. | reduce the potential | |||
exposure to blood and body | ||||
fluids. This is a single-use, | ||||
disposable device, provided | ||||
as sterile. | ||||
Design features | Ear Loops, | |||
Tie-on, | ||||
4 layers | Ear loops: XT10A1; | |||
Tie-on: XT10B1; | ||||
3 layers | Different | |||
Analysis 1 | ||||
Mask Styles | Flat pleated | Flat pleated | Same | |
Material | Outer | |||
facing | ||||
layer | Polypropylene | Polypropylene | Same | |
Middle | ||||
layer | 1. Polypropylene |
- Melt-blown cloth
(polypropylene) | 1. Melt-blown cloth
(polypropylene) | Similar |
| | Inner
Facing
layer | Polypropylene | Polypropylene | Same |
| | Nose
piece | Galvanized iron wire | Polyethylene coated
steel wire | Different
Analysis 1 |
| | Ear
loops,
Ties | -Ear loops: Polyester,
spandex
-Ties: Polypropylene | -Ear loops: Polyester silk &
Polyurethane filament
-Ties: Polypropylene | Similar
Analysis 1 |
| Color | | Green | Blue | Different
Analysis 2 |
| Dimension | | - Mask body for ear-loop
type:
14.5cm×9cm (S),
17.5cm×9.5cm (M),
18cm×9.3cm (L),
22cm×9.5cm (XL);
- Mask body for Tie-on type:
14.5cm×9cm (S),
17.5cm×9.5cm (M),
18cm×9.3cm (L),
22cm×9.5cm (XL).
The smallest sizes mask
(14.5cm×9cm) are for adult
population only. | Mask body for ear-loop
type:
17.5cm×9.5cm &
14.5cm×9.5cm
Mask body for Tie-on type:
17.5cm×9.5cm | Different
Analysis 3 |
| OTC use | | Yes | Yes | Same |
| Shelf life | | 2 years | 2 years | Same |
| Single Use | Yes | Yes | Same | |
| Sterility | Sterile | Sterile | Same | |
| Sterilization
method and
S.A.L. | Sterilized by ethylene
oxide gas, SAL=10-6 | Sterilized by ethylene
oxide gas, SAL=10-6 | Same | |
| ASTM F2100 Level | Level 3 | Level 3 | Same | |
Table 1 General Comnarison
5
6
Analysis 1: the two devices have some difference in design features and materials, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectiveness of device.
Analysis 2: The subject device (Green) has different color to the predicate device (Blue), but all proposed devices are conducted the biocompatibility test. The difference does not raise additional questions for safety and effectiveness of device.
Analysis 3: the two devices have some difference in dimensions, the little deviation in dimensions does not raise additional questions for safety and effectiveness of device.
8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face 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);
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;
Item | Purpose | Acceptance Criteria | Results |
---|---|---|---|
Synthetic | Demonstrate | 29 samples out of 32 | Pass |
Table 2 - Performance Testing
7
| Blood
Penetration
ASTM
F1862 | resistance
to liquid
penetration | pass (AQL 4%)
Level 3 pass at
160mmHg | 32 out of 32 pass at 160
mmHg |
|--------------------------------------------------------------|------------------------------------------|---------------------------------------------|-----------------------------------------------|
| Particulate
Filtration
Efficiency
ASTM
F2299 | Demonstrate
particulate
filtration | Level 3 pass at ≥98% | Pass
Filtration Efficiency (%)
≥ 99.80% |
| Bacterial
Filtration
Efficiency
ASTM
F2101 | Demonstrate
bacterial
filtration | Level 3 pass at ≥98% | Pass
Percent BFE (%)
≥ 99.80% |
| Differential
Pressure
(Delta P)
EN 14683
Annex C | Demonstrate
breathability | Level 3 pass at ≤ 6.0
mmH2O/cm² | Pass
Average 4.2 mm H2O/cm² |
| Flammability
16 CFR
1610 | Demonstrate
flame
resistance | Class I | Pass |
Table 4 - Biocompatibility Testing
Item | Subject Device | Result |
---|---|---|
Cytotoxicity | Under the conditions of the study, the subject device was non-cytotoxic | Pass |
Irritation | Under the conditions of the study, the subject device was non-irritating | Pass |
Sensitization | Under the conditions of the study, the subject device was non-sensitizing | Pass |
9.0 _Clinical Test Conclusion
No clinical study is included in this submission.
10.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K211454.