(195 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is described as a protective barrier (surgical face mask) intended to prevent the transfer of microorganisms and fluids, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical face mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (polypropylene layers, aluminum nosepiece, polyester/Lycra ear loops) and the performance studies focus on physical properties and filtration efficiency, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask and its purpose as a barrier.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, fluid resistance, flammability, and biocompatibility. These are tests to evaluate the mask's ability to act as a barrier and be safe for contact, not to diagnose a condition or analyze a sample from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. Surgical face masks do not perform this function.
N/A
Intended Use / Indications for Use
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 of the wearer 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
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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.
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 Performed:
- ASTM 2100, 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 Syntehtic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus;
- EN 14683 Annex C, Medical Face Masks - Requirements and Test Methods;
- 16 CFR 1610, Standard for 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
Clinical Test Performed: No clinical testing was performed.
Key results:
- Fluid Resistance: Passed 80 mmHg (ASTM F1862) for multiple lots.
- Particulate Filtration Efficiency (PFE): PASSED 99.866% (Lot 20201013), 99.9784% (Lot 20201022), 99.9879% (Lot 20201105) (ASTM F2299).
- Bacterial Filtration Efficiency (BFE): PASSED 99.9% for multiple lots (ASTM F2101).
- Differential Pressure: Average 3.9 mmH2O/cm² (Lot 20201013, 20201022), Average 4.2 mmH2O/cm² (Lot 20201105) (EN 14683 Annex C).
- Flammability: Class 1 (16 CFR 1610) for multiple lots.
- Biocompatibility: Non-cytotoxic (ISO 10993-5), non-sensitizing (ISO 10993-10), non-irritating (ISO 10993-10).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance: 80 mmHg
- Particulate Filtration Efficiency (PFE): ≥ 95%
- Bacterial Filtration Efficiency (BFE): ≥ 95%
- Differential Pressure:
§ 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.
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March 30, 2021
Intco Medical(HK) Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K202708
Trade/Device Name: Surgical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 19, 2021 Received: March 22, 2021
Dear Prithul Bom:
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 (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,
For Ryan Ortega, PhD Acting 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) K202708
Device Name Surgical Face Mask
Indications for Use (Describe)
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 of the wearer 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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Image /page/3/Picture/0 description: The image shows the logo and address of INTCO Medical (HK) Co., Ltd. The logo features the company name in blue, with a stylized graphic of a sun or flower above it. The address is listed as Flat/RM 19c, Lockhart Centre 301-307 Lockhart road, Wan Chai, Hong Kong.
K202708
510(K) SUMMARY
1. Submitter's Identification:
INTCO Medical (HK) Co., Ltd. Flat/RM 19c, Lockhart Centre 301-307 Lockhart road, Wan Chai, Hong Kong
Contact Person:
Max Li Product Manager Phone number: 86-511-83174088 Fax: 86-511-83174188 Email: maxli@intco.com
Date summary prepared:
March 30, 2021
-
- Device Name: Surgical Face Masks Trade Name: Surgical Face Mask
-
- Device Classification Name: Mask, Surgical (21 CFR 878.4040) Device Classification Panel: General Hospital
-
- Device Class: Class II
-
- Product Code: FXX Mask, Surgical
4
6. Predicate Device:
- Zhende Medical Co., Ltd. ● Medical Mask(K201729)
7. Reason for 510(k) Submission:
New device.
8. Device Description:
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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.
9. Intended Use/Indications for Use:
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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
5
| Feature | (Proposed Device)
Surgical Face Masks | (Predicate Device)
K201729 | Remarks |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) # | Proposed Device
K202708 | K201729 | Proposed device is
same as or similar to
the primary predicate |
| Manufacturer | INTCO Medical
(HK) Co., Ltd. | Zhende Medical Co
Ltd. | NA |
| Common Name | Surgical Face Mask | Medical Mask | Common name of the
proposed device is
similar to the predicate
device |
| Classification | Class II | Class II | Device class of the
proposed device is the
same as the predicate
device |
| Product Code | FXX | FXX | Product code of the
proposed device is the
same as the predicate
device |
| Intended Use | 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 of
the wearer to blood and | The Medical 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 of
the wearer to blood and
body fluids. This is a | The intended use of the
proposed device is the
same as the predicate
device. |
| | body fluids. This is a
single use, disposable
device(s), provided
non-sterile. | single use, disposable
device(s), provided
non-sterile. | |
| Materials | | | |
| Outer Layer | Polypropylene
Spunbond
Color: Blue | Spun-bond
Polypropylene
Color: Blue | Materials of the
proposed device are the
same as or similar to
the predicate device |
| Inner Layer | Polypropylene
Spunbond | Spun-bond
Polypropylene | |
| Filter Media Layer | Polypropylene
Meltblown | Melt Blown
Polypropylene filter | |
| Ear Loops | Ear loops:
Polyester/lycra knitted
Diameter: 0.3 cm
Length: 17.5 cm. | Ear loops:
Polyester/Spandex | |
| Nosepiece | Malleable aluminum
strip
Width: 0.3 cm
Length: 10 cm | Malleable
polypropylene with iron
wire | |
| Specifications and
Dimensions | Length: 165 ± 19 mm
Width: 102 ± 19 mm | Length: 180 ± 10 mm
Width: 95 ± 10 mm | Specifications and
dimensions of the
proposed device are
similar to the predicate
device |
| Mask Style | Flat pleated | Flat pleated | The mask style of the
proposed device is the
same as the predicate
device |
| Sterility | Non-sterile | Non-sterile | The proposed product
and predicate device are
non-sterile. |
| ASTM F2100
Level | Level 1 | Level 1 | The proposed product
and predicate device
have the same ASTM
F2100 Level |
| Performance
Testing
(Completed) | | | |
| Fluid Resistance | Fluid Resistant at 80
mmHg
Lot 20201013 31/32
Passed 80 mmHg
Lot 20201022 32/32
Passed 80 mmHg
Lot 20201105 32/32
Passed 80 mmHg
ASTM F1862 | Fluid Resistant at 80
mmHg
ASTM F1862 | Fluid resistant
performance of the
proposed device is the
same as the predicate
device |
| Particulate Filtration
Efficiency (PFE) | Lot 20201013 32/32
PASSED 99.866%
Lot 20201022 32/32
PASSED 99.9784%
Lot 20201105 32/32
PASSED 99.9879%
ASTM F2299 | ≥ 95%
ASTM F2299 | Particulate Filtration
Efficiency performance
of the proposed device
is similar to the
predicate device |
| Bacterial Filtration
Efficiency (BFE) | Lot 20201013 32/32
PASSED 99.9%
Lot 20201022 32/32
PASSED 99.9%
Lot 20201105 32/32
PASSED 99.9%
ASTM F2101 | ≥ 95%
ASTM F2101 | Bacterial Filtration
Efficiency performance
of the proposed device
is similar to the
predicate device |
| Differential Pressure |