(216 days)
The disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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 face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm.
The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask are sold non-sterile and are intended to be single use,disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask, seeking to demonstrate substantial equivalence to a predicate device. It addresses the physical and filtration performance of the mask, rather than the performance of an AI/ML-driven medical device. Therefore, many of the requested criteria relating to AI/ML device performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, and human-in-the-loop performance, are not applicable to this document.
However, I can extract and present the information available regarding the acceptance criteria and the study that proves the device meets those criteria for this medical face mask.
Device: Disposable Medical Face Mask (Model TP-001)
Product Code: FXX
Regulation Number: 21 CFR 878.4040
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The device model TP-001 is stated to meet both Level 2 and Level 3 performance requirements in ASTM F2100. The table below combines the acceptance criteria and the observed performance for both levels as presented in the document.
| Test Item (Performance Level 2/Level 3) | Acceptance Criteria (Level 2) | Acceptance Criteria (Level 3) | Reported Device Performance (Model TP-001 - across 3 lots) | Verdict |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | BFE ≥ 98% | BFE ≥ 98% | Lot A: 99.9%, Lot B: 99.9%, Lot C: 99.9% | Pass |
| Differential Pressure (Delta-P) (EN 14683:2019, Annex C) | Delta-P < 6.0 mmH2O/cm² | Delta-P < 6.0 mmH2O/cm² | Lot A: 2.24 mmH2O/cm², Lot B: 2.17 mmH2O/cm², Lot C: 2.07 mmH2O/cm² | Pass |
| Sub-micron Particulate Filtration Efficiency (PFE) at 0.1 micron (ASTM F2299) | PFE ≥ 98% | PFE ≥ 98% | Lot A: 99.9%, Lot B: 99.9%, Lot C: 99.9% | Pass |
| Resistance to Penetration by Synthetic Blood (ASTM F1862) | Fluid resistant claimed at 120 mmHg | Fluid resistant claimed at 160 mmHg | 32 out of 32 per lot pass at 120 mmHg; 32 out of 32 per lot pass at 160 mmHg | Pass |
| Flame Spread (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 | Pass |
Additionally, for biocompatibility:
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance (Model TP-001) | Result |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5:2009) | Noncytotoxic | Device is noncytotoxic | Pass |
| Irritation (ISO 10993-10:2010) | Nonirritating | Device is nonirritating | Pass |
| Sensitization (ISO 10993-10:2010) | Nonsensitizing | Device is nonsensitizing | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Performance Tests: For performance tests, the document states "3 non-consecutive lots tested, using a sample size of 32/lot" for some tests like fluid resistance. For other tests (BFE, PFE, Differential Pressure), results are provided for 3 lots (Lot A, B, C), implying samples were taken from each of these lots. The exact number of samples tested per lot for each specific test (other than fluid resistance) is not explicitly stated, but it's understood to be sufficient to demonstrate compliance with the standards.
- Data Provenance: The device manufacturer, Zhejiang The Purples Protective Products Co.,Ltd, is located in China. The testing was conducted as part of a premarket notification for submission to the U.S. FDA. The document does not specify if the tests were performed in China or other regions, nor does it explicitly state if the data is retrospective or prospective, but as it pertains to a new device submission, it would implicitly be prospective testing of newly manufactured lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a physical device performance study (e.g., filtration, fluid resistance), not an AI/ML-based diagnostic or imaging device. The "ground truth" is established by adherence to standardized test methods (e.g., ASTM, EN, ISO) and laboratory measurements of physical properties, not by expert human interpretation of clinical data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. As this is not an AI/ML device where human interpretation or consensus is required for ground truth, adjudication methods are irrelevant. The test results are based on objective, standardized physical measurements.
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 is a physical device (face mask). There is no "human reader" involved in its direct performance assessment in the context of an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical device (face mask). There is no algorithm or AI component to assess for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by standardized laboratory testing and measurements according to recognized international and US standards. These standards define the test methodologies and the criteria for acceptable performance. Examples include:
- ASTM F2101 (Bacterial Filtration Efficiency)
- EN 14683 (Differential Pressure)
- ASTM F2299 (Particulate Filtration Efficiency)
- ASTM F1862 (Synthetic Blood Penetration)
- 16 CFR Part 1610 (Flammability)
- ISO 10993 (Biocompatibility - Cytotoxicity, Irritation, Sensitization)
8. The sample size for the training set
Not Applicable. This is a physical device, not an AI/ML model. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI/ML model or training set, this question is not relevant. The "ground truth" for device acceptance is defined by adherence to established material and performance standards, as measured through laboratory testing.
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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 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.
January 16, 2022
Zhejiang The Purples Protective Products Co.,Ltd % Doris Chen Staff Shanghai Jiushun Enterprise Management Technology Service Co., Ltd. Room 1502, BaoAn Building, No.800 Dongfang Road Shanghai, 200122 China
Re: K211833
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 17, 2021 Received: December 22, 2021
Dear Doris Chen:
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 (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, 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) K211833
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Chapter 5. 510(k) Summary
510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR
807.92.
The assigned 510(k) Number:K211833
Summary Prepared Date:December 17, 2021
1. Applicant :
Sponsor Name: Zhejiang The Purples Protective Products Co.,Ltd
Address:No.45, Suhua Street, Suxi Town, Yiwu City, Zhejiang Province, China.
Contact Person (including title): Lihui Jiang (Manager)
Phone:+86-579-85178961
2. Submission Correspondent:
Contact Person: Doris Chen
Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
Address: Room 1502,BaoAn Buiding,No.800 Dongfang Road,Shanghai,China.
Tel: +86-21-50931939
Email: doris-chen@isosh.com
3. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Face Mask |
| Trade Name: | Disposable Medical Face Mask |
| Classification Name: | Mask,Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
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Predicate Device Information 4.
Predicate Device
| Sponsor: | Foshan Xinbao Technology Co., Ltd |
|---|---|
| Common Name: | Surgical apparel |
| Trade Name: | Surgical Mask |
| 510(k) number: | K202424 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
5. Device Description
The disposable medical face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm.
The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask are sold non-sterile and are intended to be single use,disposable devices.
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Intended Use / Indications for Use 6.
The disposable medical face mask is 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(s), provided non-sterile.
7. Comparison with predicate device
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Zhejiang The PurplesProtective Products Co.,Ltd | Foshan Xinbao TechnologyCo., Ltd. | -- |
| Product Name | Disposable Medical FaceMask | Surgical Mask | -- |
| K Number | K211833 | K202424 | -- |
| Product Code | FXX | FXX | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Intended use/Indications for Use | The disposable medical maskare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a singleuse, disposable device(s),provided non-sterile. | The Surgical Masks areintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These masks areintended for use ininfection control practices toreduce potential exposureto blood and body fluids.This is a single use,disposable device, providednonsterile. | Same |
| Mask style | Flat pleated, 3 layers. | Flat pleated,3 layers. | Same |
| Design feature | Ear loop | Ear loop | Same |
Table 1 General Comparison
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| Material | Outerfacinglayer | Spun-bond non-woven fabric | Spun-bond polypropylene | SimilarNote 1 | |||
|---|---|---|---|---|---|---|---|
| Middlelayer | Melt blown polypropylene filter | Melt blown polypropylene | Same | ||||
| Innerfacinglayer | Spun-bond non-woven fabric | Spun-bond polypropylene | SimilarNote 1 | ||||
| Nosepiece | Malleable aluminum wire | Galvanized iron wire | DifferentNote 1 | ||||
| Earloops | Spandex | Nylon and Spandex | DifferentNote 1 | ||||
| Color | Blue | Blue | Same | ||||
| Dimension (Width) | 17.5cm±1cm | 17.5cm±1cm | Same | ||||
| Dimension(Length) | 9.5cm±1cm | 9.5cm±1cm | Same | ||||
| OTC use | Yes | Yes | Same | ||||
| Sterility | Non-Sterile | Non-Sterile | Same | ||||
| Use | Single Use, Disposable | Single Use, Disposable | Same | ||||
| ASTMF2100 | Level | Level 2 | Level 3 | Same | |||
| 3non-consecutive lots tested,using a sample size of 32/lot. | Level 2 | Level 3 | |||||
| Fluid resistancePerformanceASTM F1862 | 32 out of 32pass at120mmHg | 32 out of 32pass at160mmHg | Pass at 120mmHg | Pass at 160mmHg | Same | ||
| Particle FiltrationEfficiencyASTM F2299 | Lot A: 99.9%Lot B: 99.9%Lot C:99.9% | Lot A: 99.9%Lot B: 99.9%Lot C: 99.9% | Pass at≥98% | Pass at≥98% | SimilarNote 2 | ||
| Bacterial FiltrationEfficiencyASTM F2101 | Lot A: 99.9%Lot B: 99.9%Lot C:99.9% | Lot A: 99.9%Lot B: 99.9%Lot C:99.9% | Pass at≥98% | Pass at≥98% | SimilarNote 2 | ||
| FlammabilityClass16 CFR 1610 | Class 1 | Class 1 | Class 1 | Class 1 | Same | ||
| DifferentialPressure(Delta -P)EN 14683 Annex C | Lot A:2.24mmH2O/cm²Lot B:2.17mmH2O/cm²Lot C:2.07mmH2O/cm² | Lot A:2.24mmH2O/cm²Lot B:2.17mmH2O/cm²Lot C:2.07mmH2O/cm² | Pass at <6.0mmH2O/cm² | Pass at <6.0mmH2O/cm² | SimilarNote 2 | ||
| Biocompatibility |
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| Cytotoxicity | Under the conditions of thestudy, the device isnoncytotoxic.Comply with ISO 10993-5. | Under the conditions of thestudy, the device isnoncytotoxic.Comply with ISO 10993-5. | Same |
|---|---|---|---|
| Irritation | Under the conditions of thestudy, the device isnonirritating.Comply with ISO 10993-10. | Under the conditions of thestudy, the device isnonirritating.Comply with ISO 10993-10. | Same |
| Sensitization | Under the conditions of thestudy, the device isnonsensitizing,Comply with ISO 10993-10. | Under the conditions of thestudy, the device isnonsensitizing,Comply with ISO 10993-10. | Same |
Note 1
The difference in the materials of the outer facing layer, Inner facing layer,nose piece and the ear loop were different from the predicate device.
The biocompatibility evaluation test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.
Note 2
For the Performance testing, the test results are not identical to each other, but they are similar and they both meet the requirement of Level 2/Level 3 medical mask according to the ASTM F2100.
8. Summary of Non-Clinical Tests Performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications as to 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:
- ハ ASTM F2299-03, Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
-
EN 14683:2019,Annex C.Method for determination of breathability (differential pressure)
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- ASTM F1862/ASTM F1862M-17, Standard test method for resistance of Surgical face A 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 Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
-
16 CFR Part 1610, Standard for the flammability of clothing textiles.
-
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.
Table 2:Performance Testing
| Test item(Performance | Proposed device | Acceptance criteria | Testresults/Verdict | ||
|---|---|---|---|---|---|
| Level 2/Level 3) | Level 2 | Level 3 | Level 2 | Level 3 | |
| Bacterial filtrationefficiency (BFE)ASTM F2101-19 | Lot A: 99.9%Lot B: 99.9%Lot C:99.9% | Lot A: 99.9%Lot B: 99.9%Lot C:99.9% | BFE≥98%. | BFE≥98%. | Pass |
| Differentialpressure, (Delta-P)EN 14683:2019,Annex C | Lot A:2.24mmH2O/cm²Lot B:2.17mmH2O/cm²Lot C:2.07mmH2O/cm² | Lot A:2.24mmH2O/cm²Lot B:2.17mmH2O/cm²Lot C:2.07mmH2O/cm² | Delta-P<6.0H2O/cm² | Delta-P<6.0H2O/cm² | Pass |
| Sub-micronparticulatefilltration efficiencyat 0.1 micron.ASTM F2299 | Lot A: 99.9%Lot B: 99.9%Lot C:99.9% | Lot A: 99.9%Lot B: 99.9%Lot C:99.9% | PFE≥98%. | PFE≥98%. | Pass |
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| Resistance topenetration bysynthetic bloodASTM F1862 | 32 out of 32 per lotpass at 120mmHg | 32 out of 32 perlot pass at 160mmHg | Fluidresistantclaimedat 120mm Hg | Fluidresistantclaimedat 160mm Hg | |
|---|---|---|---|---|---|
| Flame spread16 CFR Part 1610 | Class 1 | Class 1 | Class 1 | Pass |
Results:All tests were passed.
Biocompatibility evaluation and test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and
ISO10993-1:2018 supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- A In Vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
-
Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices
—Part 10: Tests for irritation and skin sensitization
- A Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices-
Part 10: Tests for irritation and skin sensitization.
| Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device isnoncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device isnonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device isnonsensitizing | Pass |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device,
Disposable Medical Face Mask is as safe, as effective, and performs as well as or better than
the legally marketed predicate device, Surgical Mask (K202424).
§ 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.