(267 days)
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile
The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter (Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.
This document is a 510(k) Summary for the Dong Hai Xiang Surgical Mask, outlining its safety and effectiveness compared to a predicate device. It details performance criteria typical for surgical masks rather than a complex AI-driven medical device. Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable here.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Device: Dong Hai Xiang Surgical Mask
Type: Surgical Apparel (Class II Medical Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Acceptance Criteria | Dong Hai Xiang Surgical Mask Performance |
|---|---|
| Fluid Resistance (ASTM F1862-17) | |
| ≥29 of 32 pass at 160 mmHg | Pass (96/96) - 32 samples from each of 3 non-consecutive lots passed at 160 mmHg. |
| Particulate Filtration Efficiency (ASTM F2299-17) | |
| ≥ 98% | Pass (96/96) - 32 samples from each of 3 non-consecutive lots showed ≥ 99.96% efficiency. |
| Bacterial Filtration Efficiency (ASTM F2101-19) | |
| ≥ 98% | Pass (96/96) - 32 samples from each of 3 non-consecutive lots showed ≥ 99.9% efficiency. |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) | |
| <6.0 mmH2O/cm² | Pass (96/96) - 32 samples from each of 3 non-consecutive lots had average pressures of 3.96, 4.14, and 4.10 mmH2O/cm². |
| Flammability (16 CFR 1610) | |
| Class 1 | Class 1 Pass (96/96) - 32 samples from each of 3 non-consecutive lots were Class 1 Pass. |
| Biocompatibility: In Vitro Cytotoxicity (ISO 10993-5: 2009) | |
| Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Skin Irritation (ISO 10993-10:2010) | |
| Non-irritating | Non-irritating |
| Biocompatibility: Skin Sensitization (ISO 10993-10:2010) | |
| Non-sensitizing | Non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For performance tests, 96 samples were used, consisting of 32 samples from each of 3 non-consecutive lots. For biocompatibility tests, the sample sizes are implicitly standard for the ISO tests cited, but specific numbers of samples or subjects are not detailed beyond the qualitative result statements.
- Data Provenance: The document does not specify the country of origin for the testing data. The testing was described as "nonclinical tests" (bench tests and biocompatibility evaluations) rather than clinical trials with human subjects. The data is retrospective in the sense that these are laboratory test results submitted to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the studies are non-clinical, objective performance tests (e.g., filtration efficiency, fluid resistance) conducted in a laboratory setting according to specified ASTM/EN/ISO standards. Ground truth is established by the results of these standardized physical and biological tests, not by expert interpretation of complex data like medical images.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements or qualitative assessments (e.g., "Pass/Fail," "Non-cytotoxic") based on established laboratory protocols and thresholds, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is typically performed for imaging or diagnostic AI devices where multiple human readers interpret cases, with and without AI assistance, to assess the AI's impact on diagnostic accuracy and efficiency. This document concerns a physical medical device (surgical mask) that does not involve human interpretation or AI assistance in its direct use.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The device is a physical product (surgical mask), not an algorithm or AI. The tests performed assess the physical properties and biological safety of the mask itself.
7. The Type of Ground Truth Used
The "ground truth" for the test set is established by:
- Standardized Bench Test Procedures: Adherence to and results from specific international standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) for evaluating the physical performance characteristics of surgical masks.
- Biocompatibility Standards: Results demonstrating compliance with ISO 10993 series standards for biocompatibility (cytotoxicity, irritation, sensitization).
These are objective, laboratory-based "ground truths" based on scientific measurements, not subjective human interpretations.
8. The Sample Size for the Training Set
Not applicable. This device is a manufactured product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
April 7, 2022
Taizhou Donghaixiang Protective Equipment Co., Ltd % Shuai Wang CEO Getilapson (Dalian) Biological Technology Co., Ltd RM. 408 NO. 207, Zhongnan Rd Dalian. 116001 China
Re: K212203
Trade/Device Name: Dong Hai Xiang Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 11, 2022 Received: March 7, 2022
Dear Shuai 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.
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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 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.
Clarence W. Murray, III, PhD 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) K212203
Device Name Dong Hai Xiang Surgical Mask
Indications for Use (Describe)
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of Title 21. CFR Section 807.92. The assigned 510(k) number: K212203 Date of Preparation: 11/01/2022
1. Contact Information
1.1 Applicant
Applicant Name: Taizhou Donghaixiang Protective Equipment Co., Ltd. Address: No.3091 Dunan Road Duqiao Town, Linhai, Zhengjiang, China 317016 Contact Person: Hong Wei Title: General Manager Telephone: +86-137-58627711 Email: usfdahuamei@hotmail.com
1.2 Consultant
Company: Getilapson (Dalian) Biological Technology Co., Ltd Address: RM. 408 NO. 207, Zhongnan Rd, Dalian, China, 116001 Contact Person: Shuai Wang Telephone: +1 503-559-0930 Email: usfdahuamei@hotmail.com
2. Device Information
Trade Name: Dong Hai Xiang Surgical Mask Common Name: Surgical Face Mask Regulatory information: Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
3. Legally Marketed Primary Predicate Device
Product name: Avianz® Surgical Face Mask_ 510(k) Number: K200847 Product Code: FXX Manufacture: MEXPO INTERNATIONAL INC.
4. Indication For Use
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adults only. The device is disposable and is indicated for single use. The device is not provided sterile.
5. Device Description
The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter
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(Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation | 21 C.F.R Section 878.4040 | 21 C.F.R Section 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Intended use | Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adults only. The device is disposable and is indicated for single use. The device is not provided sterile. | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from the 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 |
| Mask Style | Flat-pleated, earloop, 3 layers | Flat-pleated, earloop, 3 layers | Same |
6. Technological Characteristics Comparison
6.1 Material Used
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate Device Avianz®Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Inner layer | Polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Polypropylene Melt-blown | Melt blown polypropylene filter | Same |
| Outer layer | Polypropylene | Spun-bond polypropylene | Same |
| Earloop | Spandex + Nylon | Polyester | Different |
| Nose piece | Polyethylene +Galvanized Iron wire | Malleable aluminum wire | Different |
6.2 Design Features
| Comparison Items | Predicate Device | Comparison |
|---|---|---|
| Dong Hai Xiang Surgical Mask | ||
| Avianz® Surgical Face Mask |
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| (K200847) | ||
|---|---|---|
| Use Environment | OTC, or Healthcare or related settings | Same |
| Single-use/ Multiple-use | Single-use | Same |
| Color | Blue | Same |
6.3 Sterility
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Sterilization | No-Sterile | No-Sterile | Same |
6.4 Dimension
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Length | 17.5cm | 17.5±1cm | Different |
| Width | 9.5cm | 9.5±1cm | Different |
6.5 Performance
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Resistance to Penetrationby Synthetic bloodASTM F1862/F1862M-17 Standard Test Methodfor Resistance ofMedical Face Masks toPenetration by SyntheticBlood (HorizontalProjection of FixedVolume at a KnownVelocity) | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: 32 Out of 32 pass at 160 mmHgLot 2: 32 Out of 32 pass at 160 mmHgLot 3: 32 Out of 32 pass at 160 mmHg | ≥ 30 Out of 32 passat 120 mmHg | Different |
| Particulate FiltrationEfficiency ASTMF2299/F2299M-03(2017) Standard TestMethod for Determiningthe Initial Efficiency ofMaterial Used in medical | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: ≥ 99.96%Lot 2: ≥ 99.96%Lot 3: ≥ 99.96% | ≥ 99.9% | Different |
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| Face Masks toPenetration byParticulates using LatexSpheres | |||
|---|---|---|---|
| Bacterial FiltrationEfficiency ASTMF2101-2019 StandardTest Method forEvaluating the BacterialFiltration Efficiency(BFE) of Medical FaceMask Materials, Using aBiological Aerosol ofStaphylococcus aureus | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: ≥ 99.9%Lot 2: ≥ 99.9%Lot 3: ≥ 99.9% | ≥98% | Different |
| Differential Pressure EN14683:2019 Medical facemasks- Requirementsand test methods | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: Average 3.96 mmH20/cm²Lot 2: Average 4.14 mmH20/cm²Lot 3: Average 4.10 mmH20/cm²(EN 14683:2019, Annex C andASTM F2100-20) | 3.0 mmH20/cm² (MILM-36954C) | Different |
| Flammability 16 CFR1610 Standard for theFlammability of ClothingTextiles Corrections | Class 1 Pass (96/96) 32 SamplesEach from 3 non-consecutive lotsLot 1: Class 1 PassLot 2: Class 1 PassLot 3: Class 1 Pass | Class 1 | Same |
6.6 Biocompatibility
| ComparisonItems | Dong Hai Xiang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| In Vitro CytotoxicityTestISO 10993-5: 2009 | ISO 10993-5; Under theconditions of the study, theproposed device extract wasdetermined to be non-cytotoxic. | ISO 10993-5; Under theconditions of the study, theproposed device extract wasdetermined to be non-cytotoxic. | Same |
| Skin Irritation TestISO 10993-10:2010 | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-irritating. | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-irritating. | Same |
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| Skin Sensitization TestISO 10993-10:2010 | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-sensitizing. | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-sensitizing. | Same |
|---|---|---|---|
| Flammability | Class 1 | Class 1 | Same |
7. Nonclinical Test
Nonclinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
7.1 Performance Test:
A bench test was conducted on Dong Hai Xiang Surgical Mask for the proposed device to determine substantial equivalence. The bench tests include the following tests:
| Performance Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid ResistancePerformance ASTMF1862-17 | Evaluate the resistance ofMedical Face Masks toPenetration by SyntheticBlood (Horizontal Projectionof Fixed Volume at a KnownVelocity) | ≥29 of 32 pass at 160 mmHg | Passed Pass (96/96) 32Samples Each from 3 non-consecutive lotsLot 1: 32 Out of 32 passat 160 mmHg |
| Lot 2: 32 Out of 32 passat 160 mmHgLot 3: 32 Out of 32 passat 160mmHg | |||
| Particulate FiltrationEfficiency ASTM F2299-17 | Evaluate the Initial Efficiencyof Material Used in medicalFace Masks to Penetration byParticulates using LatexSpheres | ≥ 98% | Pass (96/96) 32 SamplesEachfrom 3 non-consecutivelotsLot 1: ≥ 99.96%Lot 2: ≥ 99.96%Lot 3: ≥ 99.96% |
| Bacterial FiltrationEfficiency ASTM F2101-19 | Evaluate the BacterialFiltration Efficiency (BFE) ofMedical Face Mask Materials,Using a Biological Aerosol ofStaphylococcus aureus | ≥ 98% | Pass (96/96) 32 SamplesEach from 3 non-consecutive lotsLot 1: ≥ 99.9%Lot 2: ≥ 99.9%Lot 3: ≥ 99.9% |
| Differential Pressure (DeltaP) EN 14683:2019, AnnexC and ASTM F2100-19. | Evaluate the medical FaceMasks' resistance to airflowacross the face maskDifferential pressure (Delta-P) | <6.0 mmH20/cm² | Passed Pass (96/96) 32Samples Each from 3 non-consecutive lotsLot 1: Average 3.96mmH20/cm²Lot 2: Average 4.14mmH20/cm² |
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| Lot 3: Average 4.10 mmH20/cm²(EN 14683:2019, Annex Cand ASTM F2100-20) | |||
|---|---|---|---|
| Flammability 16 CFR 1610 | Evaluate the medical FaceMasks' flammability whenexposed to a direct source ofignition | Class 1 | Class 1 Pass(96/96) 32 SamplesEach from 3 non-consecutive lotsLot 1: Class 1 PassLot 2: Class 1 PassLot 3: Class 1 Pass |
7.2 Biocompatibility Evaluation and Test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- 7.2.1 In Vitro Cytotoxicity Test (ISO 10993-5: 2009 )
- 7.2.2 Skin Irritation Test(ISO 10993-10:2010)
7.2.3 Skin Sensitization Test (ISO 10993-10:2010)
| BiocompatibilityEvaluation and Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| 7.2.1In Vitro Cytotoxicity TestISO 10993-5: 2009 | Evaluate under theconditions of the study,the proposed deviceextract was determined tobe non- cytotoxic. | Non-cytotoxic. | ISO 10993-5; Under theconditions of the study, theproposed device extract wasdetermined to be non-cytotoxic. |
| 7.2.2Skin Irritation TestISO 10993-10:2010 | Evaluate under theconditions of the study,the proposed deviceextract was determined tobe non- irritating. | Non-irritating. | ISO 10993-10; Under theconditions of the study, theproposed device extract wasdetermined to be non-irritating. |
| 7.2.3Skin Sensitization TestISO 10993-10:2010 | Evaluate under theconditions of the study, theproposed device extract wasdetermined to be non-sensitizing. | Non-sensitizing | ISO 10993-10. Under theconditions of the study, theproposed device extract wasdetermined to be non-sensitizing. |
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device, Dong Hai Xiang Surgical Mask, is as safe, as effective and performs as well as or better than the legally marketed device.
§ 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.