(88 days)
The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
The Altor Safety 3-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch. The product model number of the subject device is : 62222. The ASTM Level of the subject device is ASTM Level 2. The subject device is manufactured with three layers: Outer Layer: Spunbond nonwoven polypropylene, Middle Layer: Melt Blown nonwoven polypropylene, Inner Layer: Spunbond nonwoven polypropylene. The subject device is provided non-sterile and is a single use, disposable device.
This document is a 510(k) premarket notification for a medical device (Altor Safety 3-Ply Surgical Mask). It is not a study proving a device meets acceptance criteria for an AI/ML-based medical device. Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through physical and performance characteristics of a surgical mask, not a software algorithm.
Here's why the requested information cannot be extracted and why the prompt's assumptions do not apply to this document:
- Acceptance Criteria for AI/ML Device: The document does not describe acceptance criteria for an AI/ML device. It details performance criteria for a physical surgical mask (e.g., bacterial filtration efficiency, fluid resistance, breathability, flammability, biocompatibility).
- Study Proving Device Meets Acceptance Criteria: The "study" described is a series of bench tests and biocompatibility assessments on the surgical mask, comparing its performance to an existing predicate device based on established ASTM and ISO standards for surgical masks. It is not a study of an AI/ML algorithm's performance or its impact on human reader effectiveness.
- Sample Size for Test Set, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to the validation of AI/ML algorithms in medical imaging or diagnostics. They are entirely inapplicable to the regulatory submission for a physical surgical mask.
- Ground Truth: For a physical mask, "ground truth" refers to established physical properties and microbiological protection levels determined by standardized testing methods, not expert consensus on interpretations or pathology findings.
- Training Set: There is no "training set" for a physical device like a surgical mask. This concept applies to machine learning models.
In summary, the provided document is a 510(k) submission for a non-AI/ML medical device (a surgical mask). The specific questions in the prompt are designed for the evaluation of AI/ML-based medical devices, which are entirely different in nature and regulatory assessment.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 23, 2021
Altor Safety LLC % Dallas Thomas Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, Florida 33418
Re: K211249
Trade/Device Name: Altor Safety 3-Ply Surgical Mask (Model:62222) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX, Dated: April 21, 2021 Received: April 26, 2021
Dear Dallas Thomas:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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) K211249
Device Name Altor Safety 3-Ply Surgical Mask (Model:62222)
Indications for Use (Describe)
The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
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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Altor Safety 3-Ply Surgical Mask
510(k) Summary K211249
5.1 General Information
23 July 2021 Preparation Date:
Submitter/Holder
Jared Scott
Altor Safety LLC
711 Executive Boulevard Suite C, Valley Cottage, NY, USA 10989
Contact Phone#: +1 845-422-8320
Contact Email:jared.scott(@altorsafety.com
Primary Submission Contact
Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, FL 33418 Mobile +1 801 556 6809 Email: dallas@thomasregulatory.com
Regulatory Information 5.2
| Subject Device Name | Altor Safety 3-Ply Surgical Mask (Model:62222) |
|---|---|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Altor Safety 3-Ply Surgical Mask |
| FDA Product Code | FXX |
| CFR References | 21 CFR 878.4040 |
| Review Panel | General Hospital |
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Altor Safety 3-Ply Surgical Mask
Identification of Predicate Device 5.3
The predicate device for this submission has been identified as the Disposable Surgical Mask K202463.
5.4 Subject Device Description
The Altor Safety 3-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch.
The product model number of the subject device is : 62222
The ASTM Level of the subject device is ASTM Level 2
The subject device is manufactured with three layers:
Outer Layer: Spunbond nonwoven polypropylene
Middle Layer: Melt Blown nonwoven polypropylene
Inner Layer: Spunbond nonwoven polypropylene
The subject device is provided non-sterile and is a single use, disposable device.
A visual representation of the device can be found in the following figure.
Image /page/4/Picture/14 description: The image shows a close-up of a blue surgical mask. The mask has multiple layers and is folded to create a pleated design. The mask also has white ear loops attached to the sides. The bottom of the image has a green and blue background with the text "Actual product may vary from image".
Figure 1: Altor Safety 3-Ply Surgical Mask Product Image
ર.ર Subject Device Specification
Design specifications:
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Size/Dimensions: ●
| Dimensions-Width | 3.625in (92 mm) |
|---|---|
| Dimensions-Length | 6.75-7.00in (171.45 mm-177.8mm ) |
- . Materials of subject device are as listed below.
| Outer Layer (Blue) | Spunbond nonwoven polypropylene |
|---|---|
| Middle Layer (White) | Melt blown nonwoven polypropylene |
| Inner Layer (White) | Spunbond nonwoven polypropylene |
| Nose Wire | Virgin polyethylene plastic, 24 gaugesoft annealed carbon steel, and kraft paper(nominal basis weight of 25 lbs. /ream) |
| Ear Band | Spandex |
ર્ડ.૯ Indications for Use
Per the current proposed product labeling, the indications for use for the Altor Safety 3-Ply Surgical Mask (Model:62222) are quoted as follows:
The Altor Safety 3-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, nonsterile, disposable device.
Please note that the above indication is slightly reworded compared to the already cleared indications for the predicate Disposable Surgical Mask K202463 and updated accordingly per current FDA Guidance. The indications for use statement also provides further clarification that is complementary to the cleared predicate indications for use.
Technological Characteristics Comparison 5.7
Below is a summary table of the technological characteristics comparison between the subject and predicate devices.
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| Device Characteristic | Proposed Subject Device | Primary Predicate Device | Comparison Analysis: Identical / Same / Similar / |
|---|---|---|---|
| Product Name | Altor Safety 3 Ply Surgical Mask | Disposable Surgical Mask | Different |
| Manufacturer | Altor Safety | Unisources Group LLC | Different |
| FDA Product Code | FXX | FXX | Identical |
| CFR Reference | 878.4040 | 878.4040 | Identical |
| Device Class | II | II | Identical |
| 510(k) reference | K211249 | K202463 | Different |
| Implanted Device | No | No | Identical |
| Intended Use | The Altor Safety 3-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device. | The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is 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 |
| DeviceCharacteristic | Proposed SubjectDevice | Primary PredicateDevice | Comparison Analysis:Identical / Same /Similar / |
| Indications foruse statement | The Altor Safety 3-PlySurgical Mask is intendedto be worn to protect boththe patient and healthcareprofessional from transferof microorganisms, bodyfluids, and particulatematerial. The AltorSafety 3-Ply SurgicalMask is intended for usein infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use, non-sterile, disposable device. | The Disposable SurgicalMask, FILTECH M201 isintended to be worn toprotect both the patientand health care personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. The disposablesurgical mask is intendedfor use in infectioncontrol practices toreduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), provided non-sterile. | Same |
| Device GenericRaw Materials | Outer Facing Layer:Spunbond nonwovenpolypropyleneMiddle Layer: MeltBlown nonwovenpolypropylene filterInner facing layer:Spunbond nonwovenpolypropyleneEar loop: Spandex | Outer Facing Layer:Spunbond polypropyleneMiddle Layer: MeltBlown polypropylenefilterInner facing layer:Spunbond polypropyleneEar loop: Spandex | Similar |
| ASTM Level | Level 2 | Level 2 | Same |
| Color (outwardfacing Layer) | Blue | Blue | Similar |
| Color (middleLayer) | White | Not-publicly Available | Different |
| Color (inwardfacing Layer) | White | Not-publicly Available | Different |
| DeviceCharacteristic | Proposed SubjectDevice | Primary PredicateDevice | Comparison Analysis:Identical / Same /Similar / |
| Colorant(s) | Submitted Independentlyto FDA by supplier asthis was consideredproprietary information. | Not-publicly Available | Different |
| PatientAnatomical Sitefor Use of Device | Nose and Mouth | Nose and Mouth | Identical |
| Mode ofOperation | Protective Mask | Protective Mask | Identical |
| Reusable orSingle Use | Single Use | Single Use | Identical |
| Sold Sterile orNon-Sterile | Non-Sterile | Non-Sterile | Identical |
| PrescriptionStatus | OTC | OTC | Identical |
| Fluid ResistancePerformanceASTM F1862-13 | Lot 1:31 out of 32 pass at120mmHgLot 2:32 out of 32 pass at120mmHgLot 3: 32 out of 32 pass at120mmHg | 32 out of 32 pass at120mmHg | Similar |
| ParticulateFiltrationEfficiency ASTMF2299 | Lot 1 : ≥99%Lot 2: ≥99%Lot 3: ≥99% | ≥98% | Similar |
| BacterialFiltrationEfficiency ASTMF2101 | Lot 1: 99.60%Lot 2: 99.80%Lot 3: 99.75% | 99.60% | Similar |
| DifferentialPressure (Delta P)EN 14683 | 2.6mmH $2$ O/cm $2$ (2 lots have an average of 2.7) | 5.5mmH $2$ O/cm $2$ | Similar |
| Flammability 16CFR 1610 | Class 1 | Class 1 | Identical |
| Cytotoxicity | Under the conditions ofthe study, the proposeddevice extract was | Under the conditions ofthe study, the proposeddevice extract was | Similar |
| DeviceCharacteristic | Proposed SubjectDevice | Primary PredicateDevice | Comparison Analysis:Identical / Same /Similar / |
| determined to be non-cytotoxic. | determined to be non-cytotoxic. | ||
| Irritation | Under the conditions ofthe study, the proposeddevice non-polar andpolar extracts weredetermined to be non-irritating. | Under the conditions ofthe study, the proposeddevice non-polar andpolar extracts weredetermined to be non-irritating. | Similar |
| Sensitization | Under the conditions ofthe study, the proposeddevice non-polar andpolar extracts weredetermined to be non-sensitizing. | Under the conditions ofthe study, the proposeddevice non-polar andpolar extracts weredetermined to be non-sensitizing. | Similar |
| Dimensions-Width | 3.625in (92 mm) | 95mm±5mm | Similar |
| Dimensions-Length | 6.75-7.00in (171.45 mm-177.8mm ) | 175mm±5mm | Similar |
| ASTM F2100Level | Level 2 | Level 2 | Identical |
Table 1.Technological Characteristics Comparison Table
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Sterilization and Shelf Life 5.8
Sterilization and Shelf Life are not applicable to the Altor Safety 3-Ply Surgical Mask subject device. The device is provided non-sterile and there is no claimed shelf life.
5.9 Biocompatibility
Biocompatibility tests of Altor Safety 3-Ply Surgical Mask have been performed on
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representative finished, sterilized devices as outlined in Table 2.
Table 2. Biocompatibility Summary & Standards Applied
| Test Method/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5:2009 | Cytotoxicity | For the test to be valid, the reagent control andthe negative control must have had a reactivityof none (grade 0) and the positive control musthave been a grade 3 or 4. Percent rounding andpercent cells without intracytoplasmic granulesare not evaluated in the event of 100% lysis.The test article met the requirements of the testif the biological response was less than or equalto grade 2 (mild). The test would have beenrepeated if the controls did not perform asanticipated. | No cytotoxicity or celllysis was noted in any ofthe test wells. No pHshift was observed at 48hours. The reagentcontrol, negative controland the positive controlperformed as anticipated. |
| ISO 10993-10:2010 | Sensitization | The responses from the challenge phase werecompared within the test animal group andbetween test and control conditions. In thefinal analysis of data, consideration was givento the overall pattern, intensity, duration andcharacter of reactions of the test as comparedto the control conditions. The controlconditions are (1) the control vehicle on thetest animals, (2) the test on the controlanimals, and (3) the control vehicle on thecontrol animals. Statistical manipulation ofdata was not applicable to this study. Gradesof 1 or greater observed in the test groupgenerally indicated sensitization, providedthat grades of less than 1 were observed onthe control animals. If grades of 1 or greaterwere noted on control animals, then thereactions of test animals that exceeded themost severe control reaction were consideredto be due to sensitization. | Unless otherwiseindicated, all animalswere observed with theexpected dermalreactionsassociated withintradermal injection ofFCA and were clinicallynormal throughout thestudy.No evidence ofsensitization wasobserved. |
| ISO 10993-10:2010 | Sensitization | The responses from the challenge phase werecompared within the test animal group andbetween test and control conditions. In the finalanalysis of data, consideration was given to theoverall pattern, intensity, duration and character of reactionsof reactions of the test as compared to thecontrol conditions. The control conditions are(1) the control vehicle on the test animals, (2)the test on the control animals, and (3) thecontrol vehicle on the control animals.Statistical manipulation of data was notapplicable to this study. Grades of 1 or greaterobserved in the test group generally indicatedsensitization, provided that grades of less than 1were observed on the control animals. If gradesof 1 or greater were noted on control animals, | Unless otherwiseindicated, all animalswere observed with theexpected dermalreactionsassociated withintradermal injection ofFCA and were clinicallynormal throughout thestudy.No evidence ofsensitization wasobserved. |
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|--|
| Test Method/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| the most severe control reaction wereconsidered to be due to sensitization. | |||
| ISO 10993-10:2010 | Irritation | The erythema and edema site scores for the testarticle and control extracts for each animal ateach scoring interval were calculated by addingthe erythema and edema scores together. Themean score of each individual animal (test andcontrol) was calculated by totaling all of theindividual site scores for each animal anddividing by 15 (3 scoring time points x 5 test orcontrol sites). The overall mean for each testarticle extract and control extract wascalculated by adding the mean score for allthree animals together and dividing by 3. Thedifference between the overall mean score ofthe test article extract and correspondingcontrol extract was calculated by subtractingthe overall mean score for the control extractfrom the overall mean score for the test articleextract. If the overall mean score of the testarticle extract was less than the overall meanscore of the corresponding control extract, 0.0was reported. The requirements of the test weremet if the difference between the test extractoverall mean score and corresponding controloverall mean score was 1.0 or less. | All animals appearednormal throughout thestudy.All injection sitesappeared normalimmediately followinginjection. |
| ISO 10993-10:2010 | Irritation | No statistical analysis of the data will beperformed. All erythema grades and edemagrades (24, 48 and 72 hours) will be calculatedseparately for each test and control for eachindividual animal. The score of a test article orcontrol on each individual animal will becalculated by dividing each of the totals by 15(3 scoring time points x 5 sites). The overallmean will be determined for each test andcontrol by adding the scores for the 3 animalsand dividing by 3. The difference between theoverall mean score of the test article extractsand corresponding control extracts will becalculated by subtracting the overall mean scorefor the control from the overall mean score forthe test article extract. If the overall mean scoreof the test article extracts is less than the overallmean score of the corresponding controlextracts, 0.0 will be recorded for the overallmean difference between test and control. If atany observation period the average reaction tothe test article extract is questionably greaterthan the average reaction to the control, the testwill be repeated using three additional rabbits.The requirements of the test are met if thedifference between the test article extract | All animals appearednormal throughout thestudy.All injection sitesappeared normalimmediately followinginjection. |
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Altor Safety 3-Ply Surgical Mask
| Test Method/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| overall mean score and the correspondingcontrol overall mean score is 1.0 or less.Ischemia or necrosis present at the majority ofthe test sites of all animals for any scoringinterval will be considered as significantregardless of the calculated result. The testarticle may fail if either of these findings areobserved at the majority of the test sites of allanimals. If the SC control sites on any animalexhibits a score 22, or if the SO control sitesexhibits a score 23, the rabbit will be replacedexhibiting the reaction. The replacement animalwill be injected with the appropriate test articleextract and control using fresh preparations. |
5.10 Performance Testing - Bench
Performance bench tests of Altor Safety 3-Ply Surgical Mask have been performed, see Table 3. The results from the performance bench testing demonstrate that Altor Safety 3-Ply Surgical Mask has met the acceptance criteria of the standard
| Test Method /Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Bacterial FiltrationEfficiency (BFE) ASTMF2101-19 | Bacterial Filtration | As per Bacterial FiltrationEfficiency (BFE) ASTM F2101-19 | Lot 1-99.60% BFELot 2-99.80% BFELot 3-99.75% BFE |
| Differential Pressure (DeltaP) EN 14683:2019 | Breathability | As per Differential Pressure (Delta P) EN14683:2019 | 2.6mmH 2 O/cm 2 (2lots have an average of2.7) |
| Synthetic BloodPenetration ResistanceASTM F1862 ISO 22609 | Fluid Resistance | As Per Synthetic Blood Penetration ResistanceASTM F1862 ISO 22609 | Lot 1:31 out of 32 passat 120mmHgLot 2:32 out of 32 passat 120mmHgLot 3: 32out of 32 pass at 120mmHg |
Table 3. Performance Testing Summary And Standards Applied
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| Test Method /Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| pass at120mmHg | |||
| Latex Particle ChallengeASTM F2299 | Penetration by Particulates | As Per Latex Particle Challenge ASTM F2299 | Lot 1 : ≥99%Lot 2: ≥99%Lot 3: ≥99% |
| Flammability of ClothingTextiles per 16 CFR Part1610 | Flammability | As Per Flammability of Clothing Textiles per 16CFR Part 1610 | Class I FlammabilityRating |
Altor Safety 3-Ply Surgical Mask
5.11 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Altor Safety 3-Ply 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.