(83 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 a surgical face mask designed to prevent the transfer of microorganisms and fluids, which is a preventive measure rather than a therapeutic treatment for a disease or condition.
No
Explanation: The device, a surgical face mask, is intended to protect against the transfer of microorganisms and fluids. It does not analyze patient data or provide medical diagnoses.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene filter, polyester ear loops, aluminum wire nose piece) and performance testing related to these physical characteristics (fluid resistance, filtration efficiency, flammability), 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 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 (layers, materials, ear loops, nose piece). There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability). These are relevant to its function as a protective barrier, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
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 a single use, disposable device(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Face Masks are blue, flat pleated masks with ear loops to hold the device in place over the user's mouth and nose and a nose piece to fit the mask to the face. The proposed device(s) are manufactured with 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 ear loops are polyester. They are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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.
Biocompatibility Testing:
- Cytotoxicity: Demonstrates biocompatibility, non-cytotoxic result.
- Irritation: Demonstrates biocompatibility, non-irritating result.
- Sensitization: Demonstrates biocompatibility, non-sensitizing result.
Performance Testing:
- Fluid Resistance: ASTM F1862. 32 out of 32 per lot passed at 120 mmHg (3 non-consecutive lots tested); 32 out of 32 per lot passed at 160 mmHg (2 non-consecutive lots tested); 30 out of 32 per lot passed at 160 mmHg (1 lot tested).
- Particulate Filtration Efficiency: ASTM F2299. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.79%; Lot2: 99.58%; Lot3: 99.6%. All passed acceptance criteria of >= 98%.
- Bacterial Filtration Efficiency: ASTM F2101. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.56%; Lot2: 99.9%; Lot3: 99.84%. All passed acceptance criteria of >= 98%.
- Differential Pressure (Delta P): EN 14683 Annex C. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 5.2 mmH2O/cm²; Lot2: 3.8 mmH2O/cm²; Lot3: 3.8 mmH2O/cm². All passed acceptance criteria of
§ 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 18, 2021
Macheng Thimble Technology Investment Co., Ltd % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai 200122 China
Re: K211631
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: May 27, 2021 Received: May 27, 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 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 Clarence W. Murray III, Ph.D. 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) K211631
Device Name Surgical Face Mask
Indications for Use (Describe)
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 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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510(k) Summary
510(k) Number : K211631 Date Prepared:2021/8/18
A. Applicant:
Manufacturer: Macheng thimble Technology Investment Co., Ltd Address: No. 7 Xiling 2nd Rd, Macheng Economic Development Zone, Hubei Province Owner number: 3016965655 Contact Person: Donghong SHENG Address: No. 7 Xiling 2nd Rd, Macheng Economic Development Zone, Hubei Province Tel: +8613910635968 Mail: 470357243@qq.com
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:
Proprietary Name: Surgical Face Mask Common Name: Surgical Face Mask Model(s): Ear loops
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
510(k) Number: K203426 Sponsor: Nantong Taiweishi Medical Technology Co., Ltd. Trade Name: Surgical Face Mask (non-sterile ) (Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)
D. Device Description:
The Surgical Face Masks are blue, flat pleated masks with ear loops to hold the device in place over the user's mouth and nose and a nose piece to fit the mask to the face. The proposed device(s) are manufactured with 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 ear loops are polyester. They are not made
4
with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
E. Indications use of the device:
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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate device | Comparison | |
|---|---|---|---|---|
| Manufacturer | MACHENG THIMBLE | |||
| TECHNOLOGY INVESTMENT CO., | ||||
| LTD | Nantong Taiweishi Medical | |||
| Technology Co., Ltd. | - | |||
| 510K number | K211631 | K203426 | - | |
| Device name | Surgical Face Mask | Surgical Face Mask (non-sterile ) | - | |
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | ||
| Indications for use | 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 a single use, disposable | ||||
| device(s), provided non-sterile. | The Disposable 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 | |||
| M | ||||
| at | ||||
| er | ||||
| ial | 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 | Malleable aluminum wire | Polyethylene | Different | |
| Ear loops | Polyester | Nylon and Spandex | Different | |
| Color | Blue | Blue | Same | |
| Dimension | ||||
| (length) | $17.5cm+/-0.5cm$ | $175mm+/-5%$ | Similar | |
| Dimension | ||||
| (Width) | $9.5cm+/-0.5cm$ | $95mm+/-5%$ | 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&3 | Level 2 | Similar | |
| Biocompatibility | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Same |
5
From the comparison we found the material of the current nose clip and the ear loop were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.
The level of the proposed device is different from the predicate device, the main performance for level 3 surgical face mask is the requirement of Fluid Resistance, the performance has conducted and the the requirement of Level 2 and level 3 medical mask according to the ASTM F 2100.
Table 2 performance testing comparison
| Item | Proposed device | Predicate device | Result |
|---|---|---|---|
| Fluid Resistance | |||
| Performance ASTM | |||
| F1862 | 32 out of 32 per lot pass at 120 mmHg, 3 | ||
| non-consecutive lots tested; | |||
| 32 out of 32 per lot pass at 160 mmHg for 2 | |||
| non-consecutive lots tested; | |||
| 30 out of 32 per lot pass at 160 mmHg for 1 lot tested. | 32 out of 32 pass | ||
| at 120 mmHg | Pass | ||
| Particulate | |||
| Filtration | |||
| Efficiency ASTM F2299 | 99.65% | 99.16% | Pass |
| Bacterial | |||
| Filtration | |||
| Efficiency ASTM F2101 | 99.76% | 99.74% | Pass |
| Differential | |||
| Pressure | |||
| (Delta P) EN 14683 | |||
| Annex C | 4.2 mmH2O/cm² | 3.7 mmH2O/cm² | Pass |
| Flammability 16 CFR | |||
| 1610 | Class 1 | Class 1 | Pass |
G. Non-Clinical Test Conclusion
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 A 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
- A 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);
6
- 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; >
| Table 3 - Biocompatibility Testing | ||
|---|---|---|
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose of the | ||
| biocompatibility testing is | |||
| to demonstrate the | |||
| biocompatibility | |||
| of the subject device. | Non-Cytotoxic | PASS | |
| Under the conditions of the | |||
| study, the device is non- | |||
| cytotoxic. | |||
| Irritation | Non-Irritating | PASS | |
| Under the conditions of the | |||
| study, the device is non- | |||
| irritating. | |||
| Sensitization | Non-Sensitizing | PASS | |
| Under the conditions of the | |||
| study, the device is non- | |||
| sensitizing |
Table 4 – Performance Testing
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | 29 out of 32 pass at | ||
| 120 mmHg for Level 2 | |||
| 29 out of 32 pass at | |||
| 160 mmHg for Level 3 | PASS | ||
| 32 out of 32 per lot pass at 120 | |||
| mmHg, 3 non-consecutive lots | |||
| tested; | |||
| 32 out of 32 per lot pass at 160 | |||
| mmHg for 2 | |||
| non-consecutive lots tested; | |||
| 30 out of 32 per lot pass at 160 | |||
| mmHg for 1 lot tested. | |||
| Particulate | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2299 | The purpose of | ||
| the performance | |||
| testing is to | ≥ 98% | PASS | |
| 3 non-consecutive lots tested, | |||
| using a sample size of 32/lot. | |||
| Lot1: 99.79% | |||
| Lot2: 99.58% | |||
| Lot3: 99.6% |
7
| Bacterial
Filtration
Efficiency
ASTM F2101 | demonstrate the
functionality of
the subject
device. | ≥ 98% | PASS
3 non-consecutive lots tested,
using a sample size of 32/lot.
Lot1: 99.56%
Lot2: 99.9%
Lot3: 99.84% |
|-----------------------------------------------------------|---------------------------------------------------------------|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Differential
Pressure (Delta P)
EN 14683
Annex C | |