(287 days)
Not Found
No
The 510(k) summary describes a standard disposable surgical face mask and does not mention any AI or ML components or functionalities. The description focuses on materials, construction, and performance based on physical filtration and barrier properties.
No.
The device is a surgical face mask designed to filter particulates and microorganisms for infection control, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical face mask intended to protect against transfer of microorganisms and particulate materials. It does not analyze patient data or provide medical diagnoses.
No
The device description clearly outlines a physical, multi-layered mask made of nonwoven and melt-blown polypropylene, with ear loops and a nose piece. It is a tangible hardware product.
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 materials in infection control practices. This is a physical barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical construction and materials of the mask, designed for filtration and physical protection.
- Performance Studies and Key Metrics: The performance studies and metrics (filtration efficiency, resistance to penetration, flame spread, biocompatibility) are all related to the physical and protective properties of the mask, not to the diagnosis of any condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.
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 materials 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 proposed device is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled.
The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex.
The nose piece contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron.
The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight.
The proposed device is sold non-sterile and is intended to be a single use, disposable device.
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 Test Conclusion:
Non-clinical tests were conducted to verify that the device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the device complies with the following standards:
Biocompatibility:
The Disposable surgical face mask has been subjected to biocompatibility studies to demonstrate the safety of device. The biocompatibility studies are in accordance with ISO10993:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Performance:
- A ASTM F2100-2020, Standard Specification for Performance of Materials Used in Medical Face Masks.
- ASTM F2101-2019, Standard Test Method for Evaluating the Bacterial Filtration A Efficiency (BFE) Of Medical Face Mask Materials, Using a nebulizer and a culture suspension of staphylococcus aureus.
- A EN 14683:2019+AC:2019 Annex C, Standard Test Method for differential pressure of Medical Face Masks
- A ASTM F2299/F2299M-03(Reapproved 2017), Standard test method for determining the initial filtration efficiency of materials used in medical face masks to penetration by particulates using latex sphere aerosol.
- ASTM F1862/F1862M-2017, Standard Test Method for Resistance of Medical △ Face Masks to penetration by synthetic blood.
- A 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles.
Clinical Test Conclusion:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to Penetration by Synthetic Blood: 32 out of 32 pass at 120 mmHg
Particulate Filtration Efficiency ASTM F2299: Pass, 98.46%
Bacterial Filtration Efficiency ASTM F2101: 99.9%
Differential Pressure (Delta P) EN 14683: Max: 4.8 mmH₂O/cm², Min: 4.2 mmH₂O/cm²
Flame spread 16 CFR 1610: Class I
Biocompatibility:
Cytotoxicity: Under the conditions of this study, the test article extract did not show potential toxicity to L929 cells, No potential cytotoxicity
Irritation: The test result showed that the response of the test article extract was categorized as negligible under the test condition, Non-Irritating
Sensitization: Under the conditions of this study, no evidence of skin sensitization in guinea pigs was found, Non-Sensitizing
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
Image /page/0/Picture/0 description: The image shows 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.
November 16, 2022
Shandong Aida Medical Products Co., Ltd Wang Bing Technical Manager Wangjiazhuang, Wangliu Street Office, Weicheng District Weifang, Shandong 261053 China
Re: K220302
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: October 17, 2022 Received: October 17, 2022
Dear Wang Bing:
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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220302
Device Name Disposable surgical face mask
Indications for Use (Describe)
The Disposable surgical face mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K220302 page 1 of 8
B-2. 510(K) Summary
Summary Date: July 23, 2021
| 1 Submitted by : | Shandong Aida Medical Products Co.,Ltd
Wangjiazhuang, Wangliu Street Office, Weicheng District,
Weifang City, Shandong province, P.R.China, 261053
0086-536-8131936
zoro@aidamasks.com |
| ------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
2 Contact Person: Primary Contact: WangBing Wangjiazhuang, Wangliu Street Office,Weicheng District, Weifang City, Shandong Province, P.R. China 0086-15263613795 zoro@aaidamasks.com
Secondary Contact: Yu guangjiang Wangjiazhuang, Wangliu Street Office, Weicheng District, Weifang City, Shandong Province P.R. China 0086-13792660238 914424647@qq.com
3 Device Information
Trade Name: Disposable surgical face mask Common/Usual Name: Disposable surgical mask Model: AD-PR02, AD-PR02-2,AD-PR02-S01,AD-PR02-S02
4
Regulatory Information Classification Name: Mask, Surgical Classification: Class II Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Description: Surgical Apparel
4 Legally Marketed Predicate device:
Trade Name: Disposable Surgical Face Mask 510(K) Number: K153496 Product Code: FXX Manufacturer: Xiantao Rayxin Medical Products Co.,Ltd.
5 Device Description:
The proposed device is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled.
The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex.
The nose piece contained in the proposed device is in the layers of facemask to allow
5
the user to fit the facemask around their nose, which is made of polypropylene and iron.
The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight.
The proposed device is sold non-sterile and is intended to be a single use, disposable device.
6 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 materials 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 Performance Data
Non-Clinical Test Conclusion:
Non-clinical tests were conducted to verify that the device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the device complies with the following standards:
Biocompatibility:
The Disposable surgical face mask has been subjected to biocompatibility studies to demonstrate the safety of device. The biocompatibility studies are in accordance with ISO10993:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests
6
for Irritation and Skin Sensitization.
Performance:
- A ASTM F2100-2020, Standard Specification for Performance of Materials Used in Medical Face Masks.
- ASTM F2101-2019, Standard Test Method for Evaluating the Bacterial Filtration A Efficiency (BFE) Of Medical Face Mask Materials, Using a nebulizer and a culture suspension of staphylococcus aureus.
- A EN 14683:2019+AC:2019 Annex C, Standard Test Method for differential pressure of Medical Face Masks
- A ASTM F2299/F2299M-03(Reapproved 2017), Standard test method for determining the initial filtration efficiency of materials used in medical face masks to penetration by particulates using latex sphere aerosol.
- ASTM F1862/F1862M-2017, Standard Test Method for Resistance of Medical △ Face Masks to penetration by synthetic blood.
- A 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles.
Clinical Test Conclusion :
No clinical study is included in this submission.
8 Substantially Equivalent (SE) Comparison with The Predicate Device:
Comparison with the predicate devices, the device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| Table B-II-1 General Comparison | |
|---|---|
| ITEM | Proposed Device | Predicate | Remark |
|---|---|---|---|
| Predicate | |||
| Device(K153496) |
7
K220302 page 5 of 8
| Manufacturer | Shandong Aida Medical
Products Co.,Ltd | Xiantao Rayxin Medical
Products Co.,Ltd. | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------|
| Trade name | Disposable surgical face
mask | Disposable Surgical
Face Mask | | |
| Classification | Class II Device, FXX (21
CFR § 878.4040) | Class II Device, FXX
(21
CFR § 878.4040) | SE | |
| 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
materials 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 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 is a single use,
disposable device(s),
provided non-sterile. | SE | |
| Mask Styles and
Design features | Ear Loops, Flat Pleated, 3
layers | Ear Loops/Tie-on, Flat
Pleated, 3 layers | Different | |
| Materials | | | | |
| | Outer Facing
Layer | Spun-bond Nonwoven
fabric polypropylene | Spun-bond
polypropylene | SE |
| | Middle layer | Melt blown polypropylene
filter | Melt blown
polypropylene filter | SE |
| | Inner Facing
Layer | Spun-bond Nonwoven
fabric polypropylene | Spun-bond
polypropylene | SE |
| | Nose clip | Polypropylene and iron | Malleable aluminum
wire | Different |
| | Tie-one | | Spun-bond
polypropylene | Different |
| | Ear loops | Polyester and spandex | Polyester | Different |
| Color | | Blue | Blue | SE |
| Dimension (Width) | | 17.5 cm +/- 5% | 17.5 cm +/- 1 cm | Different |
| Dimension (Length) | | 9.5 cm +/- 5% | 9.5 cm +/- 1 cm | Different |
| OTC use | | Yes | Yes | SE |
| Sterility | | No | No | SE |
| Single Use | | Yes | Yes | SE |
| ASTM F2100-2020 | | Level 2 | Level 2 | SE |
| Biocompatibility | | ISO10993 | ISO10993 | SE |
8
K220302 page 6 of 8
Table B-II-2 Performance Characteristic Comparison
| Test Methodology | Proposed Device | Predicate
Device(K153496) | ASTM F2100-2020
Requirements for Level
2 Classification | Remark |
|----------------------------------------------------|----------------------------------|----------------------------------|---------------------------------------------------------------|--------|
| Resistance to
Penetration by
Synthetic Blood | 32 out of 32 pass
at 120 mmHg | 32 out of 32 pass
at 120 mmHg | 29 out of 32 pass at
120 mmHg | Meet |
9
K220302 page 7 of 8
| ASTM F1862 | ||||
|---|---|---|---|---|
| Particulate | ||||
| Filtration Efficiency | ||||
| ASTMF2299 | Pass | 98.46% | $\u2265$ 98% | Meet |
| Bacterial Filtration | ||||
| Efficiency | ||||
| ASTMF2101 | 99.9% | 98.7% | $\u2265$ 98% | Meet |
| Differential | ||||
| Pressure (Delta P) | ||||
| EN 14683 | Max: 4.8 mmH₂O | |||
| /cm² | ||||
| Min: 4.2 mmH₂O | ||||
| /cm² | 4.2 mmH₂O /cm² |