(134 days)
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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical characteristics, intended use, and comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the standards for a Level 2 surgical face mask, primarily following ASTM F2100-11.
| Acceptance Criteria (ASTM F2100-11 Level 2 Standard) | Proposed Device Performance | Predicate Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862 at 120 mmHg) | 32 out of 32 pass | 32 out of 32 pass |
| Particulate Filtration Efficiency (ASTM F2299) | 99.88% pass | 98.46% pass |
| Bacterial Filtration Efficiency (ASTM F2101) | 99.6% pass | 98.7% pass |
| Differential Pressure (Delta P) (MIL-M-36954C) | 3.0 mmH2O/cm² pass | 4.2 mmH2O/cm² pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility - Irritation | Non-irritating | Non-irritating |
| Biocompatibility - Sensitization | Non-sensitizing | Non-sensitizing |
2. Sample Size and Data Provenance for Test Set
- Fluid Resistance (ASTM F1862): 32 samples were tested. The country of origin for the data is not explicitly stated but implied to be from the manufacturer's testing (Xiantao Zhibo Non-woven Products Co., Ltd in China). The data is from non-clinical performance testing.
- For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not provided in the summary, but the results indicate tests were conducted and met the criteria. The data provenance is non-clinical performance testing, likely conducted by or for the manufacturer.
3. Number of Experts and Qualifications for Ground Truth
This document describes technical performance testing of a physical device (surgical face mask), not an AI/software device that requires expert review for ground truth. Therefore, this section is not applicable. The "ground truth" here is established by standardized laboratory testing methods and measured physical properties.
4. Adjudication Method for Test Set
Not applicable, as this is laboratory testing of a physical product against defined standards, not an expert-driven assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a premarket notification for a physical medical device (surgical face mask), not an AI/software device that would typically undergo MRMC studies to assess human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this is a physical medical device.
7. Type of Ground Truth Used
The ground truth is established through standardized laboratory testing protocols and measurements according to recognized consensus standards such as ASTM F2100-11, ASTM F1862, ASTM F2101, MIL-M-36954C, 16 CFR 1610, and ISO 10993 for biocompatibility. These standards define the methods and acceptance criteria for measuring specific physical and biological properties of the face mask.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device.
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January 24, 2019
Xiantao Zhibo Non-Woven Products Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai, 200122 Cn
Re: K182514
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 26, 2018 Received: Oct 29, 2018
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182514
Device Name Disposable Surgical Face Mask
Indications for Use (Describe)
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 a single use, disposable device(s), provided non-sterile.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201.5 Labeling) | Over-The-Counter Use (21 CFR 201.5 Labeling) |
|---|---|
| --------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------- |
_ | 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
K182514 Date Summary Prepared: 2018-12-23
A. Applicant:
Xiantao Zhibo Non-woven Products Co., Ltd Address: NO.8 in Industrial Park, Hefeng Road, Xiantao City, Hubei, China Contact Person: Mr. Yao Sanyu Tel: +86-15327866903 Email: 1208599360@qq.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: SURGICAL FACE MASK Common Name: SURGICAL FACE MASK Model(s): Ear Loop
- Regulatory Information Classification Name: Surgical Face Mask Classification: Class II. Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products 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 transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids.
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This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
F. Technological Characteristics Comparison Table
Table 1 Comparison of technological characteristics between proposed device and predicate devices
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| 510 (k) | K182514 | K153496 | - |
| Manufacturer | Xiantao Zhibo Non-wovenProducts Co., Ltd | Xiantao Rayxin Medical ProductsCo., ltd. | - |
| Product Name | SURGICAL FACE MASK | SURGICAL FACE MASK | Same |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Intended use | The Surgical Face Masks areintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to bloodand body fluids. This is a singleuse, disposable device(s),provided non-sterile. | The Disposable Surgical FaceMasks are intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material.These face masks are intendedfor use in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s), providednon-sterile. | Similar |
| Material | |||
| Outer facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Similar |
| Inner facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Similar |
| Ear loops | Polyester | Polyester | same |
| Design features | Color: WhiteEar loops | Color: BlueEar Loops or Tie-On | Different |
| Mask Style | Flat Pleated | Flat Pleated | Similar |
| Specificationand Dimension | Length: $17.5cm \pm 1cm$Width: $9.5cm \pm 1cm$ | Length: $17.5cm \pm 1cm$Width: $9.5cm \pm 1cm$ | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| PerformanceTesting (ASTMF2100-11) | Level 2 | Level 2 | Same |
| Fluid ResistancePerformanceASTM F1862 | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Same |
| ParticulateFiltrationEfficiency ASTMF2299 | pass at 99.88% | pass at 98.46% | Similar |
| BacterialFiltrationEfficiency ASTMF2101 | pass at 99.6% | pass at 98.7% | Similar |
| DifferentialPressure (Delta P)MIL-M-36954C | pass at $3.0mmH_2O/cm^2$ | pass at $4.2 mmH_2O/cm^2$ | Similar |
| Flammability 16CFR 1610 | Class 1 | Class 1 | same |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Under the conditions of the study, the predicate device extract was determined to be non-cytotoxic. | Similar |
| Irritation | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Under the conditions of the study, the predicate device non-polar and polar extracts were determined to be non-irritating. | Similar |
| Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Under the conditions of the study, the predicate device non-polar and polar extracts were determined to be non-sensitizing. | Similar |
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G. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as
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the predicate device. The test results demonstrate that the proposed device conforms to the recognized standards ASTM F2100-11, ASTM F1862, ASTM F2101, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
H. Summary of Clinical Performance Test
No clinical study is included in this submission.
l. Conclusion
The subject device is a safe, as effective, and perform as well or better than the legally marketed predicated K153496, Xianto Rayxin Medical Products Disposable Surgical Mask.
§ 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.