(153 days)
No
The document describes a standard surgical mask and its physical properties and performance metrics, with no mention of AI or ML.
No.
A therapeutic device is used to treat or prevent a disease or condition. This device is a surgical mask intended for protection from the transfer of microorganisms, not for direct treatment or prevention of a disease in a therapeutic sense.
No
Explanation: The device is a surgical mask intended for protection and infection control, not for diagnosing any medical conditions. Its function is to filter microorganisms and fluids, not to provide diagnostic information.
No
The device description clearly outlines physical components like non-woven polypropylene, ear loops, and a nose strip, indicating it is a physical medical device, not software-only.
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 individuals from the transfer of microorganisms, body fluids, and particulate material. 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). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies and Key Metrics: The performance studies focus on the physical properties and filtration capabilities of the mask (BFE, PFE, resistance to penetration, differential pressure, flame spread). These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition, monitor a disease, or screen for a health issue.
In summary, the device is a physical barrier intended for infection control, not a diagnostic test.
N/A
Intended Use / Indications for Use
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 potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
Product codes
FXX
Device Description
The Durio Surgical Face Mask is a non-sterile, single use, flat-pleated style surgical mask with ear loops and nose piece.
The Durio Surgical Face Mask is available in three or four ply models. In all cases, the inner and outer layers of the Durio Surgical Face Mask are made of non-woven spunbond polypropylene (PP). The outer layer repels fluid and droplets. The middle layer is made of non-woven melt blown PP fabric for filtration by mechanical blocking and electrostatic attraction. For the four-ply model, there is an additional middle layer made of non-woven spunbound PP. The ear loops are made of polyester covered spandex yarn. The elastic ear loops pull inward from welding on the outer layer to reduce gaps as the side between the face and mask. The nose strip is made of zinc electro galvanized steel wire allowing adjustability and to let it stand fixed for better fit.
The Durio Surgical Face Mask is provided in blue. The device is not made from any natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate safety and effectiveness of the Durio Surgical Face Mask and to show substantial equivalence to the predicate device, Durio completed various bench performance tests. No animal or clinical testing was required. Results confirm that the design inputs and performance specification of the device are met. Durio Surgical Face Masks passed the testing in accordance with internal requirements and standards as shown below, supporting its safety, effectiveness, and substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization) per ISO 10993-5 and ISO 10993-10
- Bacterial Filtration Efficiency (BFE) per ASTM F2101-19
- Sub-micron Particulate Efficiency (PFE) per ASTM F2100-19
- Resistance to Penetration by Synthetic Blood per ASTM F1862/F1862M-17 ●
- Differential Pressure per ASTM F2100-19
- Flame Spread per 16 CFR 1610 (Class 1)
- Shipping Performance per ASTM D4169-16 ●
Predicate Device(s)
Reference Device(s)
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
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July 17, 2023
Durio PPE SDN BHD % Ms. Sarah Fitzgerald Senior Consultant, Regulatory and Quality Affairs Emergo Global Consulting, LLC 2500 Bee Caves Rd., Bldg. 1, Ste. 300 Austin, Texas 78746
Re: K230395
Trade/Device Name: Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 12, 2023 Received: June 12, 2023
Dear Ms. Fitzgerald:
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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230395
Device Name Durio Surgical Face Mask
Indications for Use (Describe)
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 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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K230395: 510(k) Summary
Durio Surgical Face Masks:
Model 501 (3-ply, blue) and Model 545 (4-ply,blue)
1. Submission Sponsor
Durio PPE SDN BHD 16, Jalan Temenggong Johor Bahru, Johor 81100 Malaysia Contact: Xavier Kong Title: Deputy General Manager
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Sarah Marie Fitzgerald Title: Senior Consultant, Regulatory and Quality Affairs
3. Date Prepared
June 16, 2023
4. Device Identification
| Trade/Proprietary Name: | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) |
|---|---|
| Common/Usual Name: | Surgical Mask |
| Classification Name: | Surgical apparel |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
| Class: | II |
| Classification Panel: | General Hospital |
5. Legally Marketed Predicate and Reference Device(s)
| Device name: | Surgical Mask |
|---|---|
| 510(k) number: | K212344 |
| Type: | Predicate |
K230395 510k Summary Page 1 of 4
4
| Manufacturer: | Xiantao Dingcheng Non-Woven Product Co., Ltd. |
|---|---|
| Device name: | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW |
| 510(k) number: | K203078 |
| Type: | Reference |
| Manufacturer: | Guangdong Kaidi Garments Co., Ltd. |
6. Indication for Use Statement
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 potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
7. Device Description
The Durio Surgical Face Mask is a non-sterile, single use, flat-pleated style surgical mask with ear loops and nose piece.
The Durio Surgical Face Mask is available in three or four ply models. In all cases, the inner and outer layers of the Durio Surgical Face Mask are made of non-woven spunbond polypropylene (PP). The outer layer repels fluid and droplets. The middle layer is made of non-woven melt blown PP fabric for filtration by mechanical blocking and electrostatic attraction. For the four-ply model, there is an additional middle layer made of non-woven spunbound PP. The ear loops are made of polyester covered spandex yarn. The elastic ear loops pull inward from welding on the outer layer to reduce gaps as the side between the face and mask. The nose strip is made of zinc electro galvanized steel wire allowing adjustability and to let it stand fixed for better fit.
The Durio Surgical Face Mask is provided in blue. The device is not made from any natural rubber latex.
8. Substantial Equivalence Discussion
The following table compares the Durio Surgical Face Mask to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| Attribute | Subject Durio Surgical Face
Mask | Predicate Surgical Mask
(K212344) | Comparison |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Product Code | FXX | FXX | Same |
| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications for Use | Surgical Mask is intended to be
worn to protect both the patient
and healthcare personnel from
transfer of microorganisms, | Surgical Mask is intended to be
worn to protect both the patient
and healthcare personnel from
transfer of microorganisms, | Same |
| Attribute | Subject Durio Surgical Face
Mask | Predicate Surgical Mask
(K212344) | Comparison |
| | 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 non sterile. | 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 non sterile. | |
| Mechanism of
Action | Physical barrier | Physical barrier | Same |
| Single-Use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Composite | Flat Pleated, 3 or 4 Layers | Flat Pleated, 3 Layers | Equivalent*
Same as reference
K203078 |
| Materials: Outer | Spunbond Polypropylene (SBPP) | Spunbond Polypropylene (SBPP) | Same |
| Materials:
Middle | Melt Blown Polypropylene
(MBPP) | Melt Blown Polypropylene
(MBPP) | Same |
| Materials: 4th
Layer | None or MBPP | None | Equivalent*
Same as reference
K203078 |
| Materials:
Inner | Hydrophilic Spunbond
Polypropylene (HPP) | Spunbond Polypropylene (SBPP) | Equivalent* |
| Materials:
Nose-Piece | Galvanized steel wire, flexible | Galvanized iron wire, flexible | Equivalent* |
| Materials:
Earloop | Polyester and Spandex | Polyester and Spandex | Same |
| Dimensions | 175mm x 95mm | 175mm x 95mm | Same |
| Color | Blue | Blue | Same |
| OTC Use | Yes | Yes | Same |
| ASTM F2100
Level | Level 2 (3-Ply)
Level 3 (4-Ply) | Level 3 | Equivalent** |
| Biocompatibility | Biocompatible per ISO 10993
Series Testing | Biocompatible per ISO 10993
Series Testing | Same |
Table 5A - Comparison of Characteristics
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- The devices have minor differences in materials. The differences do not raise new or different questions related to the safety or effectiveness of the device, and performance and biocompatibility evaluation and testing addresses these differences; therefore the devices are substantially equivalent.
** Testing was conducted within alignment with the labeled protection level; therefore the devices are substantially equivalent.
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of the Durio Surgical Face Mask and to show substantial equivalence to the predicate device, Durio completed various bench performance tests. No animal or clinical testing was required. Results confirm that the design inputs and performance specification of the device are met. Durio Surgical Face Masks passed the testing in accordance with internal requirements
6
and standards as shown below, supporting its safety, effectiveness, and substantial equivalence to the predicate device.
- Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization) per ISO 10993-5 and ISO 10993-10
- Bacterial Filtration Efficiency (BFE) per ASTM F2101-19
- Sub-micron Particulate Efficiency (PFE) per ASTM F2100-19
- Resistance to Penetration by Synthetic Blood per ASTM F1862/F1862M-17 ●
- Differential Pressure per ASTM F2100-19
- Flame Spread per 16 CFR 1610 (Class 1)
- Shipping Performance per ASTM D4169-16 ●
10. Clinical Performance Data
No animal or clinical testing was required.
11. Statement of Substantial Equivalence
The Durio Surgical Face Mask has the same indications for use as the Surgical Mask (K212344). Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, the Durio Surgical Face Mask has been determined to be substantially equivalent to predicate Surgical Mask (K212344).