(154 days)
Not Found
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.
The device, a disposable surgical mask, is for protection against microorganisms and body fluids, not for treating any medical condition or improving health.
No
The device is a surgical mask intended for protection against the transfer of microorganisms, body fluids, and particulate material, not for diagnosing conditions.
No
The device description clearly outlines physical components (mask body, nose clip, ear loop) made of various materials, indicating it is a hardware device.
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 against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. 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 and Key Metrics: The performance studies and metrics focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are not diagnostic performance metrics like sensitivity, specificity, or AUC, which are typical for IVDs.
- Lack of IVD-related terms: The document does not contain any terms or descriptions related to in vitro diagnostic testing, such as "assay," "reagent," "sample," "analyte," "diagnosis," or "screening."
In summary, the device is a physical barrier intended for infection control, not a test performed on biological samples to diagnose a condition.
N/A
Intended Use / 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 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 Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The body of 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 non-woven fabric, 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% cm, the length of the ear loop is 16cm, 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 non-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
Non-clinical tests were conducted to verify that the proposed device met all design specifications as same 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, Standard 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;
Comparison of Performance Testing (Subject device vs. Predicate Device):
- Fluid Resistance Performance ASTM F1862: 32 out of 32 pass at 120 mmHg for both devices. Acceptance Criteria (level 2): 29 out of 32 pass at 120 mmHg. Result: Similar.
- Particulate Filtration Efficiency ASTM F2299: 99.62% for subject, 99.88% for predicate. Acceptance Criteria (level 2): >= 98%. Result: Similar.
- Bacterial Filtration Efficiency ASTM F2101: 99.9% for subject, 99.6% for predicate. Acceptance Criteria (level 2): >= 98%. Result: Similar.
- Differential Pressure (Delta P) EN 14683 Annex C: 5.2mmH2O/cm^2 for subject, 3.0mmH2O/cm^2 for predicate. Acceptance Criteria (level 2):
§ 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
Build Correspondence
Image /page/0/Picture/2 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
December 9, 2020
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: K201893
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 26, 2020 Received: October 26, 2020
Dear Ivy Wang:
We have reviewed vour 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,
For CAPT Elizabeth Claverie, M.S. 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) K201893
Device Name Disposable Surgical Mask
Indications for Use (Describe)
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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary
K201893 Summary prepared Date: 2020-08-13
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: Kang JianLi Tel: +86-592-7557106 Fax: +86-592-7199255
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: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device: K182514 SURGICAL FACE MASK
D. Indications for use:
4
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 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.
E. Device Description:
The Disposable Surgical Mask is composed of mask body, nose clip and ear loop. The body of 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 non-woven fabric, 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% cm, the length of the ear loop is 16cm, 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 non-sterile and is intended to be single use, disposable devices.
| Table 1 General Comparison | ||||
|---|---|---|---|---|
| Device | Subject Device | Predicate Device | Result | |
| Manufacturer | XIAMEN PROBTAIN | |||
| MEDICAL TECHNOLOGY CO., | ||||
| LTD | Xiantao Zhibo Non-woven | |||
| Products Co., Ltd | - | |||
| 510K number | K201893 | K182514 | - | |
| Product Name | Disposable Surgical Mask | SURGICAL FACE MASK | Similar | |
| Model | MP9017 | |||
| Classification | Class II Device, FXX (21 CFR | |||
| 878.4040) | Class II Device, FXX (21 CFR | |||
| 878.4040) | Same | |||
| 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 | ||||
| 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 | |||
| Material | Outer | |||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Middle | ||||
| layer | Melt blown non-woven fabric | Melt blown polypropylene filter | Same |
F. Comparison with predicate device
5
| Inner
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
|---|---|---|---|
| Nose clip | Plastic materials and iron wire | Malleable aluminum wire | Different |
| Ear | |||
| loops | Spandex | Polyester | Different |
| Color | Blue | white | Different |
| Design | |||
| Feature | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same |
| Dimension | |||
| (Length) | $17.5\pm5%$ cm | $17.5cm\pm1cm$ | Similar |
| Dimension | |||
| (Width) | $9.5cm\pm5%cm$ | $9.5cm\pm1cm$ | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 | |||
| level | Level 2 | Level 2 | Same |
| Biocompatibil | |||
| ity | Meet ISO10993 | Meet ISO10993 | Same |
Table 2 – Comparison of Performance Testing
| Item | Subject device | Predicate Device | Acceptance
Criteria (level 2) | Result |
|-----------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|---------|
| Fluid Resistance
Performance
ASTM F1862 | 32 out of 32 pass
at 120 mmHg | 32 out of 32 pass at
120 mmHg | 29 out of 32 pass at
120 mmHg | Similar |
| Particulate
Filtration
Efficiency
ASTM F2299 | 99.62% | 99.88% | ≥ 98% | Similar |
| Bacterial
Filtration
Efficiency
ASTM F2101 | 99.9% | 99.6% | ≥ 98% | Similar |
| Differential
Pressure (Delta
P) EN 14683
Annex C | 5.2mmH2O/cm² | 3.0mmH2O/cm² | 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, Standard 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;
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
Based on the nonclinical tests performed, the subject device is as effective, and performs as well as the legally marketed predicate device, K182514 Xiantao Zhibo Non-woven Products Surgical Face Mask.