(100 days)
The Disposable Medical 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.
The Disposable Medical Masks are single use, three-layer, flat –folded masks with ear strings or ties and nose clip. The two models are exact same except the loop versus tie on design. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The three layers fabric are held together by ultrasonic welding. The earloops/tie-on ties are held in place over the users' mouth and nose by two strings welded to the facemask. The earloops are made of 19cm spandex and the tie-on ties are made of 90cm spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) premarket notification for a Disposable Medical Mask (Models: JBHY01, JBHY02). It details non-clinical performance testing to demonstrate substantial equivalence 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 ASTM F2100-19 Level 3 acceptance criteria for medical face masks.
| Item | Acceptance Criteria (Level 3) | Reported Device Performance (Model JBHY01) | Reported Device Performance (Model JBHY02) |
|---|---|---|---|
| Synthetic Blood Performance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | All 3 lots (Lot20200701, Lot20200706, Lot202007014) showed 32 out of 32 pass at 160 mmHg. | All 3 lots (Lot20200701, Lot20200706, Lot202007014) showed 32 out of 32 pass at 160 mmHg. |
| Particulate Filtration Efficiency (ASTM F2299) | $\geq$ 98% | Lot20200701: Max: 99.48%, Min: 99.93% (Note: Apparent typo, min should be <= max?)Lot20200706: Max: 99.85%, Min: 99.68%Lot202007014: Max: 99.93%, Min: 99.73% | Lot20200701: Max: 99.98%, Min: 99.79%Lot20200706: Max: 99.89%, Min: 99.79%Lot202007014: Max: 99.89%, Min: 99.78% |
| Bacterial Filtration Efficiency (ASTM F2101-19 and EN 14683:2019 Annex B) | $\geq$ 98% | Lot20200701: Max: 99.85%, Min: 99.63%Lot20200706: Max: >99.88%, Min: 99.77%Lot202007014: Max: 99.85%, Min: 99.66% | Lot20200701: Max: 99.83%, Min: 99.59%Lot20200706: Max: 99.83%, Min: 99.59%Lot202007014: Max: 99.83%, Min: 99.50% |
| Differential Pressure (Delta P) (ASTM F2100-19 and EN 14683:2019 Annex C) | < 6.0 mmH2O/cm² | All 3 lots showed Max: 3.7 mmH20/cm²Min: 3.1 mmH20/cm². | All 3 lots showed Max: 3.7 or 3.8 H₂O/cm²Min: 3.2 H₂O/cm². |
| Flammability (16 CFR 1610) | Class 1 (Burn time $\geq$ 3.5 seconds) | All 3 lots for both models achieved Class I. | All 3 lots for both models achieved Class I. |
| Biocompatibility - Cytotoxicity (ISO10993-5:2009) | Non-Cytotoxic | No cytotoxic potential (Meet the Criteria). | Not explicitly listed, but the section "Table3 Biocompatibility Testing" states for "Proposed device" "No cytotoxic potential" which includes both models. |
| Biocompatibility - Irritation (ISO10993-10:2010) | Non-Irritating | No Irritation (Meet the Criteria). | Not explicitly listed, but the section "Table3 Biocompatibility Testing" states for "Proposed device" "No Irritation" which includes both models. |
| Biocompatibility - Sensitization (ISO10993-10:2010) | Non-Sensitizing | Not considered a sensitizer (Meet the Criteria). | Not explicitly listed, but the section "Table3 Biocompatibility Testing" states for "Proposed device" "Not considered a sensitizer" which includes both models. |
2. Sample Size Used for the Test Set and Data Provenance
- Synthetic Blood Performance: 32 masks were tested for each lot (3 lots per model). The document states "Sampling: AQL 4% for BFE, PFE, Delta P; 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤2passing". This implies that for the Synthetic Blood test, 32 masks were the sample size per lot per model.
- Flammability: 32 masks were tested for each lot (3 lots per model).
- BFE, PFE, Delta P: The sampling detail "AQL 4% for BFE, PFE, Delta P" is mentioned. However, the exact sample size for these tests per lot is not explicitly stated as a number like for Synthetic Blood and Flammability, but rather the results show max/min values from a batch.
- Data Provenance: The testing was conducted by Anhui JBH Medical Apparatus Co., Ltd., based in Mingguang City, Chuzhou, Anhui, China. The data would therefore be from China, and the studies are non-clinical, likely prospective for the purpose of this submission. The report states "Non-clinical tests were conducted to verify that the proposed device met all design specifications".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical device performance study (e.g., material testing, filtration efficiency, flammability) typically conducted in a laboratory setting, not involving human experts for ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" is defined by the objective measurement standards of the ASTM and EN tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective laboratory tests. There is no adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a medical device (face mask), not an AI-enabled diagnostic or analytical tool involving human readers or comparative effectiveness studies of human performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. Refer to point 5.
7. The Type of Ground Truth Used
The ground truth is established by objective, standardized laboratory test methods and performance specifications outlined in:
- ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks)
- ASTM F1862 (Resistance of Medical Face Masks to Penetration by Synthetic Blood)
- EN 14683 (Medical Face Masks-Requirements and Test Methods)
- ASTM F2101 (Bacterial Filtration Efficiency (BFE))
- ASTM F2299 (Particulate Filtration Efficiency (PFE))
- 16 CFR 1610 (Flammability of clothing textiles)
- ISO 10993-5 (Biological Evaluation - Cytotoxicity)
- ISO 10993-10 (Biological Evaluation - Irritation and Sensitization)
These standards define the methodologies and the "ground truth" performance metrics such as filtration percentages, pressure differentials, and flammability classifications.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device and therefore does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. Refer to point 8.
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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.
May 14, 2021
Anhui JBH Medical Apparatus Co., Ltd. % Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China
Re: K210302
Trade/Device Name: Disposable Medical mask (Model: JBHY01, JBHY02) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 21, 2021 Received: April 21, 2021
Dear Eva Li:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, Ph.D. Acting 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) K210302
Device Name Disposable Medical Mask (Model:JBHY01, JBHY02)
Indications for Use (Describe)
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) | Residential Use Part 21 CFR 601 Subpart D For The Continued Use of 21 CFR 601 Subpart D |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K210302
510(K) Summary
A. Applicant
Anhui JBH Medical Apparatus Co., Ltd. Address: No. 116 qicang Road, Mingguang City, Chuzhou, Anhui, China 239400 Contact Person: Dandan Yang Tel: 0086-550-8108866 Email: 982755038@qq.com
Prepared Date: May 14, 2021
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device
Trade Name: Disposable Medical Mask
| Model | Description |
|---|---|
| JBHY01 | Ear Loops, Flat Pleated, 3 layers |
| JBHY02 | Tie-On, Flat Pleated, 3 layers |
Regulatory Information
Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K110455 Kimberly-Clark KC100 Mask Kimberly-Clark
D. Intended use of the device:
The Disposable Medical Masks are intended to be worn to protect both the patient and
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healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Disposable Medical Masks are single use, three-layer, flat –folded masks with ear strings or ties and nose clip.
The two models are exact same except the loop versus tie on design.
The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The three layers fabric are held together by ultrasonic welding.
The earloops/tie-on ties are held in place over the users' mouth and nose by two strings welded to the facemask. The earloops are made of 19cm spandex and the tie-on ties are made of 90cm spandex.
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly.
The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Anhui JBH Medical Apparatus Co., Ltd. | Kimberly-Clark | — |
| 510(K) number | K210302 | K110455 | — |
| Model Name | Disposable Medical Mask | Kimberly-Clark KC100 Mask | Similar |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend use | The Disposable Medical 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. | The Kimberly-Clark KC100 Procedure Mask(s) is 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. The Kimberly-Clark KC100 Procedure Mask(s) is a | Same |
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Anhui JBH Medical Apparatus Co., Ltd. No. 116 qicang Road, Mingguang City, Chuzhou, Anhui, China 239400
| single use, disposable devices, | ||||
|---|---|---|---|---|
| provided non-sterile. | ||||
| Model | Ear Loops, Tie-On, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | Same | |
| Material | Outerfacinglayer | non-woven Spun-bondpolypropylene | Spun-bond polypropylene | Same |
| Middlelayer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Innerfacinglayer | non-woven Spun-bondpolypropylene | Spun-bond polypropylene | Same | |
| Earloops/ties | Spandex | Polyester/lycra knitted | Similar | |
| Noseclip | PVC coated wire | PVC coated wire | Same | |
| Color | Blue | Variety (include blue) | Similar | |
| Dimension(length) | 175mm ±3mm | 165 ±19mm | Similar | |
| Dimension(width) | 95 mm ±2mm | 102 ±19mm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single use, Disposable | Single use, Disposable | Same | |
| ASTM F2100Level | Level 3 | Level 1 | Similar*1 | |
| Biocompatibility | ISO10993 | ISO10993 | Same*2 |
*1 Similar Discussion:
The proposed device conducted the test and the pass the Level 3 Acceptance Criteria per ASTM F2100, the predicate device pass the level 1 Acceptance Criteria ASTM F2100. The test and the acceptance is following:
| ASTM F2100-19 | ||
|---|---|---|
| Level 1 | Level 3 | |
| BFE% ASTM F2101 | ≥95 | ≥98 |
| PFE% ASTM 2299 | ≥95 | ≥98 |
| Synthetic BloodASTM 1862 | Pass at 80 mmHg | Pass at 160 mmHg |
| Differential pressureEN 14683 | <5.0 mmH2O/cm² | <6.0 mmH2O/cm² |
| Flammability16CFR Part 1610 | Class 1 | Class 1 |
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Sampling: AQL 4% for BFE, PFE, Delta P; 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤2passing Flammability: 32 masks were tested, all samples burn time is 3.5 seconds or more ACCEPTABLE ( 3.5 sec is a pass)
*2 The biocompatibility test conducted of the proposed device and the predicate device
| Item | Standard/Acceptance Criteria | proposeddevice | predicate device |
|---|---|---|---|
| Cytotoxicity | ISO10993-5:2009/Non-Cytotoxic | Meet the Criteria | Meet the Criteria |
| Irritation | ISO10993-10:2010/Non-Irritating | Meet the Criteria | Meet the Criteria |
| Sensitization | ISO10993-10:2010/Non-Sensitizing | Meet the Criteria | Meet the Criteria |
G. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as 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 A Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A 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);
A 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;
A ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
A 16 CFR 1610, Standard for the Flammability of clothing textiles;
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Anhui JBH Medical Apparatus Co., Ltd. No. 116 qicang Road, Mingguang City, Chuzhou, Anhui, China 239400
Table 2-performance Testing
| Model | JBH01 | |||
|---|---|---|---|---|
| Item | AcceptanceCriteria(level 3) | Result ofLot20200701 | Result ofLot20200706 | Result ofLot202007014 |
| Synthetic BloodPerformanceASTM F1862 | 29 out of 32pass at 160mmHg | 32 out of 32 passat 160mmHg | 32 out of 32 passat 160mmHg | 32 out of 32 passat 160mmHg |
| ParticulateFiltration EfficiencyASTM F2299 | $\ge$ 98% | Max:99.48%Min:99.93% | Max:99.85%Min:99.68% | Max:99.93%Min:99.73% |
| Bacterial FiltrationEfficiencyASTM F2101-19EN 14683:2019Annex B | $\ge$ 98% | Max: 99.85%Min:99.63% | Max: >99.88%Min:99.77% | Max:99.85%Min:99.66% |
| DifferentialPressure(Delta P)ASTM F2100-19EN 14683:2019Annex C( mmH2O/cm2) | < 6.0 | Max:3.7mmH20/cm2Min:3.1 mmH20/cm² | Max:3.7mmH20/cm2Min:3.1 mmH20/cm² | Max:3.7mmH20/cm2Min:3.1 mmH20/cm² |
| Flammability16 CFR 1610(IBE=Test Articleignited, butextinguished) | Class 1 (Burntime $\ge$ 3.5seconds) | Class I | Class I | Class I |
| Model | JBH02 | |||
| Item | AcceptanceCriteria(level 3) | Result ofLot20200701 | Result ofLot20200706 | Result ofLot202007014 |
| Synthetic BloodPerformanceASTM F1862 | 29 out of 32pass at 160mmHg | 32 out of 32 passat 160mmHg | 32 out of 32 passat 160mmHg | 32 out of 32 passat 160mmHg |
| ParticulateFiltration EfficiencyASTM F2299 | $\ge$ 98% | Max: 99.98%Min: 99.79% | Max: 99.89%Min: 99.79% | Max: 99.89%Min: 99.78% |
| Bacterial FiltrationEfficiencyASTM F2101-19EN 14683:2019Annex B | $\geq$ 98% | Max: 99.83%Min: 99.59% | Max: 99.83%Min: 99.59% | Max: 99.83%Min: 99.50% |
| DifferentialPressure(Delta P)ASTM F2100-19EN 14683:2019Annex C( mmH2O/cm²) | < 6.0 | Max: 3.7 H₂O/cm²Min: 3.2 H₂O/cm² | Max: 3.8 H₂O/cm²Min: 3.2 H₂O/cm² | Max: 3.7 H₂O/cm²Min: 3.2 H₂O/cm² |
| Flammability16 CFR 1610(IBE=Test Articleignited, butextinguished) | Class 1 (Burntime $\geq$ 3.5seconds) | Class I | Class I | Class I |
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Anhui JBH Medical Apparatus Co., Ltd. No. 116 qicang Road, Mingguang City, Chuzhou, Anhui, China 239400
Table3 Biocompatibility Testing
| ltem | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|
| In Vitro Cytotoxicity TestMTT with 10FBS extractISO10993-5:2009 | Under theconditions of thestudy, the deviceis non-cytotoxic. | Non-Cytotoxic | No cytotoxic potential. |
| Skin Sensitization TestGuinea Pig MaximizationTest 0.9% SodiumChloride Injection ExtractISO10993-10:2010Skin Sensitization TestGuinea Pig MaximizationTest Sesame Oil ExtractISO10993-10:2010 | Under theconditions of thestudy, the deviceis non-irritating. | Non-Irritating | No Irritation. |
| Skin Irritation Test0.9% Sodium ChlorideInjection ExtractISO 10993-10:2010Skin Irritation TestSesame Oil ExtractISO 10993-10:2010 | Under theconditions of thestudy, the deviceis non-sensitizing | Non-Sensitizing | Not considered asensitizer. |
H. Summary of Clinical Performance Test
No clinical study is included in this submission.
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I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210302, the Disposable Medical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Kimberly-Clark KC100 Mask cleared under K110455.
§ 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.