(109 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 disposable surgical face masks are intended to protect against the transfer of microorganisms, body fluids, and particulate material, and not to treat or cure a medical condition.
No
Explanation: The device is a surgical face mask, which is a barrier device used to prevent the transfer of microorganisms and fluids, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (spun-bond polypropylene, polyethylene film, iron core, nylon, spandex) and performance studies focus on physical properties (filtration, fluid resistance, flammability), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from transferring microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from 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 used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, fluid resistance, breathability, flammability, and biocompatibility (cytotoxicity, irritation, sensitization). These are all relevant to a physical barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not perform any of these functions.
N/A
- Not Found
Intended Use / Indications for Use
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Disposable Surgical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are 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)
Non-clinical tests were conducted to verify that the proposed device met all design specification for the standards and test methods. The test results demonstrated that the proposed device complies with 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:
- 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
- A 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);
- EN 14683, Medical Face Masks-Requirements and Test Methods;
- 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;
Performance tests:
Fluid Resistance: 32 out of 32 pass at 160 mmHg, 3 lots
Particulate Filtration Efficiency: Average 99.929%, 99.947%, 99.978%
Bacterial Filtration Efficiency: Average 99.8%, 99.9%, 99.8%
Differential Pressure: Average 3.7mmH2O/cm², 3.8mmH2O/cm², 3.8mmH2O/cm²
Flammability: Class 1
Biocompatibility tests:
Cytotoxicity: Non-cytotoxic. Under the conditions of the study, the device is non-cytotoxic.
Irritation: Non-irritating. Under the conditions of the study, the device is non-irritating.
Sensitization: Non-sensitizing. Under the conditions of the study, the device is non-sensitizing.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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 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.
August 3, 2022
Makrite Industries, Inc. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K220550
Trade/Device Name: Disposable Surgical Face Mask (M663BE, M663BT) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX
Dear Ivy Wang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 14, 2022. Specifically, FDA is updating this SE Letter for a typographical error in the company name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, 240-402-1840, brent.showalter(@fda.hhs.gov.
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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 14, 2022
Makrite Industries Co, Inc. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K220550
Trade/Device Name: Disposable Surgical Face Mask (M663BE, M663BT) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 10, 2022 Received: May 16, 2022
Dear Ivy 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.
2
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K220550
Device Name Disposable Surgical Face Mask (M663BE, M663BT)
Indications for Use (Describe)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K220550 Page 1 of 4
510(K) Summary
Prepared date: 2022-02-16 A. Applicant: MAKRITE INDUSTRIES, INC. Address: 11F-5., NO.79, Sec.1, Xintai 5th Rd., XiZhi Dist., New Taipei City 221, Taiwan Contact Person: Bob Wen Tel: +886-2-26982419 Fax: +886-2-26982423 Email: bobwen(@makrite.com.tw
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Disposable Surgical Face Mask Common Name: Disposable Surgical Mask Model: M663BE, M663BT
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K210433 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.
D. Indications for use:
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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.
5
E. Device Description:
The Disposable Surgical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of four layers: the inner(4th layer) and outer(1st layers are made of spun-bond polypropylene, the 2nd layer is made of polyethylene film and the 3rd layer is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex, and the ties are made of spun-bond polypropylene. Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| Manufacturer | MAKRITE INDUSTRIES, INC. | Wuhan Dymex Healthcare Co., Ltd. | ||
| 510K number | - | K210433 | - | |
| Model name | Disposable Surgical Face Mask | Surgical Face Mask | Same | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Intended use | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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. | The 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. | Same | |
| Model | Ear loop, Tie-on, Flat pleated, 4 layers | Ear loop, Tie-on, Flat pleated, 3 layers | Different | |
| Material | Outer layer | Spun-bond polypropylene | Same | |
| Middle layer | 2nd layer: polyethylene film | / | ||
| 3rd layer: Melt blown polypropylene | Melt-blown Polypropylene | Same | ||
| Inner layer | Spun-bond polypropylene nonwoven fabric | Spun-bond polypropylene | Same | |
| Nose clip | Iron core coated with polypropylene | Malleable polyethylene wire | Different | |
| Ear loops | Nylon, Spandex | Spandex | Different | |
| Ties | Spun-bond polypropylene | Spunbond Polypropylene | Same | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | 17.5cm+/-0.45cm | 17.5cm+/-0.2cm | Similar | |
| Dimension (Width) | 9.5cm+/-0.45cm | 9.5cm+/-0.2cm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 3 | Level 3 | Same | |
| Fluid Resistance Performance ASTM F1862 | 32 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg | Same | |
| Particulate Filtration Efficiency ASTM F2299 | $\geq 98%$ | $\geq 98%$ | Same | |
| Bacterial Filtration Efficiency ASTM F2101 | $\geq 98%$ | $\geq 98%$ | Same | |
| Differential Pressure (Delta P) EN 14683 Annex C | $ 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); |
- EN 14683, Medical Face Masks-Requirements and Test Methods; A
-
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;
| Test Methodology | Purpose | Acceptance Criteria: | Result |
|---|---|---|---|
| Fluid Resistance | ASTM F2100 Level 3 | ||
| 29 out of 32 pass at | |||
| 160 mmHg for level 3 | Pass | ||
| 32 out of 32 pass at 160 mmHg, 3 lots | |||
| Particulate | |||
| Filtration | |||
| Efficiency | The purpose of | ||
| the performance | |||
| testing is to | |||
| demonstrate the | |||
| functionality of | |||
| the subject | |||
| device. | ≥ 98% | Pass | |
| Average 99.929%, 99.947%, | |||
| 99.978% | |||
| Bacterial Filtration | |||
| Efficiency | ≥ 98% | Pass | |
| Average 99.8%, 99.9%, | |||
| 99.8% | |||
| Differential | |||
| Pressure |