(196 days)
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 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, provided non-sterile/sterile.
The proposed devices are three-layer, flat pleated masks. A mask is composed of a mask body, a nose piece, two ear loops and two side tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a iron wire with polypropylene covering. In order to improve the wearing comfort, two side tapes are welded to the mask body along the width direction to cover the mask edges. The side tapes are made of spunbond polypropylene nonwoven fabric (the same material as the inner layer). The proposed device contains two models, and the structure, materials and dimensions of the two models are exactly the same except the status. Disposable Surgical Face Mask is provided non-sterile and Disposable Surgical Face Mask (Sterile) is provided sterile. They are both intended to be single use, disposable devices. The proposed devices can meet the requirements for the performance class of Level 3 specified in ASTM F2100.
This document primarily concerns the regulatory approval (510(k) clearance) of a medical device, specifically a Disposable Surgical Face Mask, by the FDA. The information provided heavily focuses on non-clinical performance testing against established standards, rather than the type of clinical study involving human-in-the-loop performance or expert consensus typically found in AI/CADe device submissions.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available within this document because the device is a physical product (a face mask) and its evaluation relies on established material and performance standards, not on image interpretation or diagnostic algorithms.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Disposable Surgical Face Mask
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the requirements for Level 3 as specified in ASTM F2100-19 and other relevant standards.
| Test (Standard) | Purpose | Acceptance Criteria per ASTM F2100-19 (AQL=4.0%) | Reported Performance (Disposable Surgical Face Mask) | Reported Performance (Disposable Surgical Mask (Sterile)) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | Pass at 160 mmHg | 96 out of 96 pass at 160 mmHg | 96 out of 96 pass at 160 mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.5%~99.7% (Average: 99.6%) | 99.7%~99.9% (Average: 99.8%) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | ≥ 98% | 99.37%~99.99% (Average: 99.74%) | 99.32%~99.85% (Average: 99.63%) |
| Differential Pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | < 6.0 mmH2O/cm² | (3.4~4.2) mmH2O/cm² (Average: 3.9 mmH2O/cm²) | (3.5~4.5) mmH2O/cm² (Average: 4.0 mmH2O/cm²) |
| Flammability (16 CFR 1610) | Verify the flammability of the proposed device can meet the requirements for Level 3 specified in ASTM F2100-19. | Class 1 | Class 1 | Class 1 |
| Biocompatibility - In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass | Pass |
| Biocompatibility - Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass | Pass |
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the performance tests (Fluid Resistance, BFE, PFE, Differential Pressure, Flammability), the document states "Statistics of three lots, 32 per lot," which means a total of 96 samples were tested for each performance criterion.
- Data Provenance: The document does not explicitly state the country of origin where the tests were performed, but the manufacturer is National Bridge Industrial (S.Z.) Co., Ltd. in China, and the submission correspondent is Shenzhen Joyantech Consulting Co. Ltd, also in China. These were non-clinical (laboratory) tests, not retrospective or prospective patient data studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The ground truth for this device (a surgical face mask) is established through standardized laboratory testing protocols (e.g., ASTM, EN, ISO standards) measuring physical properties like filtration efficiency and fluid resistance, not through expert human interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, the evaluation relies on objective, quantifiable measurements from laboratory tests, not subjective assessments requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers' performance is compared with and without AI assistance. This document describes the testing of a physical medical device (face mask).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithmic or software-based device. "Standalone" performance would refer to the device's inherent physical characteristics as measured by the non-clinical tests listed.
7. The Type of Ground Truth Used
- The "ground truth" for the surgical face mask is defined by established engineering and material performance standards (e.g., ASTM F2100-19, ASTM F1862, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 for biocompatibility) and the test methodologies prescribed within them. These standards define the acceptable range or threshold for various physical and biological properties.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set was used.
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Image /page/0/Picture/0 description: The image shows 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.
December 20, 2021
National Bridge Industrial (S.Z.) Co., Ltd. % Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K211750
Trade/Device Name: Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: October 15, 2021 Received: November 22, 2021
Dear Grace Liu:
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.
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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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211750
Device Name Disposable Surgical Face Mask Disposable Surgical Face Mask (Sterile)
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 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, provided non-sterile/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
K211750
1. Contact Details
1.1 Applicant information
| Applicant Name | National Bridge Industrial (S.Z.) Co., Ltd. |
|---|---|
| Address | Phase 2, N.B.I. Building, No. 501-502, Sili Road, Guanlan,Longhua District, Shenzhen, Guangdong, China |
| Contact person | Yang Haixiong |
| Phone No. | +86-13502801741 |
| sznbi061@nbi.com.cn | |
| Date Prepared | 2021-10-14 |
1.2 Submission Correspondent
| Image: logo | Shenzhen Joyantech Consulting Co., Ltd1713A, 17th Floor, Block A, Zhongguan Times Square,Nanshan District, Shenzhen, Guangdong Province, China |
|---|---|
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Disposable Surgical Face MaskDisposable Surgical Face Mask (Sterile) |
|---|---|
| Common name | Surgical Face Mask |
| Classification name | Mask, Surgical |
| Review Panel | General Hospital |
| Product code | FXX |
| Device Class | II |
| Regulation No. | 21 CFR 878.4040 |
3. Legally Marketed Predicate Device
| Trade Name | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) |
|---|---|
| ------------ | ------------------------------------------------------------------ |
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National Bridge Industrial (S.Z.) Co., Ltd.
Product: Disposable Surqical Face Mask Disposable Surgical Face Mask (Sterile)
| 510(k) Number | K202843 |
|---|---|
| Product Code | FXX |
| Manufacturer | B.J.ZH.F.Panther Medical Equipment Co., Ltd. |
4. Device Description
The proposed devices are three-layer, flat pleated masks. A mask is composed of a mask body, a nose piece, two ear loops and two side tapes.
The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex).
The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a iron wire with polypropylene covering.
In order to improve the wearing comfort, two side tapes are welded to the mask body along the width direction to cover the mask edges. The side tapes are made of spunbond polypropylene nonwoven fabric (the same material as the inner layer).
The proposed device contains two models, and the structure, materials and dimensions of the two models are exactly the same except the status. Disposable Surgical Face Mask is provided non-sterile and Disposable Surgical Face Mask (Sterile) is provided sterile. They are both intended to be single use, disposable devices.
The proposed devices can meet the requirements for the performance class of Level 3 specified in ASTM F2100.
5. Intended Use/Indication 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 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, provided non-sterile/sterile.
6. Technological Characteristics Comparison
| Comparison item | Proposed Device(K211750) | Predicate Device(K202843) | Comment | |
|---|---|---|---|---|
| Manufacturer | National Bridge Industrial (S.Z.)Co., Ltd. | B.J.ZH.F.Panther MedicalEquipment Co., Ltd. | None | |
| Product name | Disposable Surgical Face Mask | Surgical Face Masks (Sterile), | None | |
| Disposable Surgical Face Mask(Sterile) | Surgical Face Masks (Non-sterile) | |||
| Product Code | FXX | FXX | Same | |
| Regulation Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same | |
| Classification | Class II | Class II | Same | |
| OTC use | Yes | Yes | Same | |
| Indications for Use | The surgical face masks areintended to be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These masksare intended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device, providednon-sterile/sterile. | The Surgical Face Mask isintended for single use byoperating room personnel andother general healthcare workersto protect both patients andhealthcare workers againsttransfer of microorganisms, bloodand body fluids, and particulatematerials. | Similar | |
| Mask style | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Same | |
| Design feature | Ear loop | Ear loop/Tie-on | Similar | |
| Single use | Yes | Yes | Same | |
| Color | Blue | Blue | Same | |
| Specifications anddimensions | 175mm×95mm:Nose piece: 90mm×3.2mmEar loop: 160mm×3.5mm | 1. 14.5cm×9cm:Nose clip: 85mm×2.9mmEar loop: 180mm×3mmTies: 910mm×10mm2. 17.5cm×9.5cm:Nose clip: 100mm×2.9mmEar loop: 180mm×3mmTies: 910mm×10mm | Similar | |
| Sterility | Non-sterile/Sterile | Non-sterile/Sterile | Same | |
| Sterilizationmethod | EO (SAL: 10-6) | EO (SAL: 10-6) | Same | |
| ASTM F2100 Level | Level 3 | Level 2 | DifferentIssue 1 | |
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | |
| Materials | ||||
| Outer layer | Spunbond Polypropylene | Spunbond Polypropylene | DifferentIssue 1 | |
| Middle layer | Meltblown Polypropylene | Meltblown Polypropylene | DifferentIssue 2 | |
| Inner layer | Spunbond Polypropylene | Spunbond Polypropylene | ||
| Nose piece | Iron wire with polypropylene covering | Medical polypropylene and Q235 | ||
| Ear loop | Polyester and spandex | Nylon and spandex | ||
| Side tape | Spunbond Polypropylene | None | ||
| Performances | ||||
| Disposable Surgical Face Mask | Disposable Surgical Face Mask (Sterile) | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | / | |
| Fluid Resistance(ASTM F1862) | Pass at 160mmHg | Pass at 160mmHg | Pass at 120mmHg | / |
| Particulate Filtration Efficiency(ASTM F2299) | Average 99.74% | Average 99.63% | Average 98.98% | |
| Bacterial Filtration Efficiency(ASTM F2101) | Average 99.6% | Average 99.8% | Average 98.92% | DifferentIssue 1 |
| Differential Pressure (Delta P)(EN 14683) | Average 3.9 mmH2O/cm² | Average 4.0 mmH2O/cm² | Average 4.4 mmH2O/cm² | |
| Flammability(16CFR 1610) | Class 1 | Class 1 | Class 1 | |
| Biocompatibility | ISO 10993-5 and ISO 10993-10;Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing and non-irritating | ISO 10993-5 and ISO 10993-10;Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing and non-irritating | ISO 10993-5 and ISO 10993-10;Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing and non-irritating | Same |
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lssue 1: The proposed device has conducted the performance testing as per ASTM F2100, the test results showed that the proposed device meet the requirements for Level 3.
Issue 2: The construction materials used are different.
7. Summary of Non-clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and acceptance criteria in the standard and test methodology. The tests were conducted according to the following standards, and the results demonstrated that the proposed device complies with the following standards:
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-
ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
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 F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
-
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
-
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Usinq a Biological Aerosol of Staphylococcus aureus
-
EN 14683:2019+AC:2019 Medical Face Masks Requirements and Test Methods
-
ASTM F2299/F2299M-03(R2017) 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
-
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
-
ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2 Tests of sterility performed in the definition, validation and maintenance of a sterilization process
-
ISO 10993-7:2008 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
ASTM F1886M-2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
| Test | Purpose | AcceptanceCriteriaper ASTMF2100-19(AQL=4.0%) | Results(Statistics of three lots, 32 per lot) | |
|---|---|---|---|---|
| Fluid | Verify the fluid | Pass at 160 | Disposable SurgicalFace Mask | Disposable SurgicalMask (Sterile) |
| 96 out of 96 pass at | 96 out of 96 pass at |
Table 2 Performance Testing
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510(k) Summary
| Resistance(ASTM F1862) | resistance of theproposed device canmeet the requirementsfor Level 3 specified inASTM F2100-19. | mmHg | 160 mmHg | 160 mmHg |
|---|---|---|---|---|
| Bacterialfiltrationefficiency (BFE)(ASTM F2101) | Verify the bacterialfiltration efficiency ofthe proposed devicecan meet therequirements for Level3 specified in ASTMF2100-19. | ≥98% | 99.5%~99.7%(Average: 99.6%) | 99.7%~99.9%(Average: 99.8%) |
| Particulatefiltrationefficiency (PFE)(ASTM F2299) | Verify the particulatefiltration efficiency ofthe proposed devicecan meet therequirements for Level3 specified in ASTMF2100-19. | ≥98% | 99.37%~99.99%(Average: 99.74%) | 99.32%~99.85%(Average: 99.63%) |
| Differentialpressure(Delta-P)(EN 14683) | Verify the differentialpressure of theproposed device canmeet the requirementsfor Level 3 specified inASTM F2100-19. | <6.0mmH2O/cm² | (3.4~4.2)mmH2O/cm²(Average: 3.9mmH2O/cm²) | (3.5~4.5)mmH2O/cm²(Average: 4.0mmH2O/cm²) |
| Flammability(16 CFR 1610) | Verify the flammabilityof the proposed devicecan meet therequirements for Level3 specified in ASTMF2100-19. | Class 1 | Class 1 | Class 1 |
Table 3 Biocompatibility Testing
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| In vitroCytotoxicity(ISO 10993-5) | Verify that the proposed deviceextract is non-cytotoxic. | The extract is non-cytotoxic underthe research conditions. | Pass |
| Skin Irritation(ISO 10993-10) | Verify that the proposed deviceextract is non-irritating. | The polar and non-polar extracts arenon-irritating under the researchconditions. | Pass |
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| Skin Sensitization(ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts arenon-sensitizing under the researchconditions. | Pass |
|---|---|---|---|
| -------------------------------------- | ------------------------------------------------------------- | ------------------------------------------------------------------------------------------- | ------ |
8. Clinical testing
Clinical testing was not performed for the proposed device.
9. Conclusion
The nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed device (K202843).
§ 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.