(275 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
A therapeutic device is used to treat a condition or disease. This device, a surgical mask, is for protection and infection control, not for treatment.
No
The device is a disposable surgical mask intended to protect against transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (mask body, nose clip, ear loop) made of materials like polypropylene, plastic, iron wire, and spandex. This indicates a hardware 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 mask is 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 components and materials of the mask. There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are not tests related to diagnosing a condition or analyzing a biological sample.
- Key Metrics: The key metrics are related to the mask's performance as a barrier and its safety for use on the skin. They are not diagnostic metrics like sensitivity, specificity, or AUC.
An In Vitro Diagnostic (IVD) device is defined as a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood.
This surgical mask does not fit this definition. It is a physical barrier device used for infection control.
N/A
Intended Use / Indications for Use
The Disposable Surgical Mask 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 sterile.
Product codes
FXX
Device Description
The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.
The size of the disposable surgical mask is 17.5*9.5cm with tolerance +-5%, the length of the ear loop is 16cm with tolerance +-5%, and the length of the nose clip should no less than 8.0cm.
The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is 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 specifications as was similar to the predicate device. 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:
- 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);
- 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;
Key Results:
Fluid Resistance Performance ASTM F1862: 32 out of 32 pass at 120 mmHg (Acceptance Criteria: 29 out of 32 pass at 120 mmHg) - PASS
Particulate Filtration Efficiency ASTM F2299: 99.77% (Acceptance Criteria: >= 98%) - PASS
Bacterial Filtration Efficiency ASTM F2101: 99.7% (Acceptance Criteria: >= 98%) - PASS
Differential Pressure (Delta P) EN 14683 Annex C: 4.26mmH2O/cm squared (Acceptance Criteria:
§ 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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July 2, 2021
Xiamen Probtain Medical Techology Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202954
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 19, 2021 Received: May 19, 2021
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.
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 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,
Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202954
Device Name Disposable Surgical Mask
Indications for Use (Describe)
The Disposable Surgical Mask 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 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
K202954
Summary prepared date: 2021-05-14
A. Applicant:
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China Contact Person: Kangjianli Tel: +86-592-7557106 Fax: +86-592-7199255 Email: kangjianli@probtain.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Surgical Mask Common Name: Disposable Surgical Mask Model(s): MP9017
Regulatory Information Classification Name: Disposable Surgical Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K100846 IMC Surgical Face Mask (non-sterile and sterile, yellow) International Medsurg Connection
D. Indications for use of the device:
4
The Disposable Surgical Mask are intended to be worn to protect 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 sterile.
E. Device Description:
The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.
The size of the disposable surgical mask is 17.5*9.5cm with tolerance +-5%, the length of the ear loop is 16cm with tolerance +-5%, and the length of the nose clip should no less than 8.0cm.
The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.
F. Comparison of technological characteristics with the predicate device.
Table 1 General Comparison
| Device | Subject Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | XIAMEN PROBTAIN MEDICAL | |||
| TECHNOLOGY CO., LTD | INTERNATIONAL MEDSURG | |||
| CONNECTION | - | |||
| 510K number | K202954 | K100846 | - | |
| Model Name | Disposable Surgical Mask | IMC Surgical Face Mask | ||
| (non-sterile and sterile, yellow) | - | |||
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 | |||
| CFR878.4040) | Same | |||
| Intended/Indications for use | The Disposable 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 to | ||||
| use in infection control practices to | ||||
| reduce the potential exposure to | ||||
| blood and body fluids. This is a | ||||
| disposable device(s), provided | ||||
| sterile. | This device is 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. | Similar | |||
| Model | MP9017 | - | - | |
| Design feature | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 | ||
| layers | Similar | |||
| Material | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clip | Plastic materials and iron wire | NA | Different | |
| Ear loops | Spandex | NA | Different | |
| Color | Blue | Yellow | Different | |
| Dimension | (Length) | 17.5±5%cm | 17.8cm (7 inches) | Different |
| (Width) | 9.5cm±5%cm | 8.9cm (3.5inches) | Different | |
| OTC use | Yes | Yes | Same | |
| Sterility | Sterile | Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 2 | Level 2 | Same | |
| Fluid Resistance | Per ASTM F1862, an acceptable quality limit of 4.0% is met for a normal single sampling plan when ≥ 29 of 32 test articles show passing results. | The surgical face mask were tested in accordance with ASTM F1862-07 test methods and meets its acceptance Criteria of Low =80, Moderate =120,High = 160. | Similar | |
| Filtration Efficiency | Particulate | The test results in average of 98.6% are in accordance with the requirements under ASTM F2299 | The surgical face mask were tested in accordance with ASTM F2299 test methods and meets its acceptance Criteria of ≥98% | Similar |
| Filtration Efficiency | Bacterial | The test results in average of 99.6% are in accordance with the requirement under ASTM F2101-19 | The surgical face mask were tested in accordance with ASTM F2101-07 test methods and meets its acceptance criteria of Low≥95%, Moderate =≥98%, High ≥98%. | Similar |
| Pressure | Differential | The test results in average of 5.0mmH2O/cm² are in accordance with the requirement 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);
- A 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;
- A ASTM F2299, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
| Item | Proposed device | Acceptance Criteria (level 2) | Result |
|---|---|---|---|
| Fluid | |||
| Resistance | |||
| Performance | |||
| ASTM | 32 out of 32 pass at 120 mmHg | 29 out of 32 pass at 120 mmHg | PASS |
Table 2 - Performance Testing
7
K202954
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen,Fujian,361100,China
| F1862 | |||
|---|---|---|---|
| Particulate | |||
| Filtration | |||
| Efficiency ASTM F2299 | 99.77% | ≥ 98% | PASS |
| Bacterial | |||
| Filtration | |||
| Efficiency ASTM F2101 | 99.7% | ≥ 98% | PASS |
| Differential | |||
| Pressure | |||
| (Delta P) EN 14683 | |||
| Annex C | 4.26mmH2O/cm² |