(230 days)
Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.
The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter. Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex. Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire. The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions and are intended to be single use, disposable devices.
This document is a 510(k) Pre-Market Notification for YADU Surgical Masks, demonstrating its substantial equivalence to a legally marketed predicate device. The information provided focuses on the technical performance of the surgical masks rather than an AI/ML powered device. Therefore, a direct mapping to the requested information about an AI/ML device is not fully applicable. However, I will extract relevant information from the provided text that corresponds to the structure of your request, interpreting "device" as the surgical mask in this context.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Test Name | Acceptance Criteria | Reported Performance (YADU Surgical Masks) |
|---|---|---|
| ASTM F2101-19 Bacterial Filtration Efficiency (BFE) (Sterile) | ≥ 95% | Lot 1: 95.1-97.4%, Lot 2: 95.1-98.4%, Lot 3: 95.1-98.4% |
| ASTM F2299-03 Penetration by Particulates (Sterile) | ≥ 95% | Lot 1: 95.1-97.9%, Lot 2: 95.1-99.6%, Lot 3: 95.1-97.4% |
| EN 14683-2019 Differential Pressure (Sterile) | < 5.0 mm H2O/cm² | 3.7-4.2 (Lot 1), 3.7-4.1 (Lot 2), 3.7-4.1 (Lot 3) |
| ASTM F1862-17 Resistance to penetration by Synthetic Blood (Sterile) | No penetration under 80 mm Hg | 32/32 pass (Lot 1), 32/32 pass (Lot 2), 32/32 pass (Lot 3) |
| 16 CFR part 1610 Flammability (Sterile - Tie-on straps) | Class 1 | 32/32 IBE (Lot 1), 32/32 IBE (Lot 2), 32/32 IBE (Lot 3) |
| ASTM F2101-19 Bacterial Filtration Efficiency (BFE) (Non-Sterile) | ≥ 95% | Lot 1: 99.8-99.9%, Lot 2: 99.2-99.9%, Lot 3: 99.8-99.9% |
| ASTM F2299-03 Penetration by Particulates (Non-Sterile) | ≥ 95% | Lot 1: 99.5-99.9%, Lot 2: 99.5-99.9%, Lot 3: 99.5-99.9% |
| EN 14683-2019 Differential Pressure (Non-Sterile) | < 5.0 mm H2O/cm² | 3.1-3.6 (N=32) (Lot 1), 3.1-3.5 (N=32) (Lot 2), 3.0-3. (N=32) (Lot 3) |
| ASTM F1862-17 Resistance to penetration by Synthetic Blood (Non-Sterile) | No penetration under 80 mm Hg | 32/32 pass (Lot 1), 32/32 pass (Lot 2), 32/32 pass (Lot 3) |
| 16 CFR part 1610 Flammability (Non-Sterile - Tie-on straps) | Class 1 | 32/32 IBE (Lot 1), 32/32 IBE (Lot 2), 32/32 IBE (Lot 3) |
| ISO 10993-5 Cytotoxicity | No Cytotoxicity | No Cytotoxicity (Sterile Mask), No Cytotoxicity (Non-Sterile Mask) |
| ISO 10993-10 Sensitization | No Sensitization | No Sensitization (Sterile Mask), No Sensitization (Non-Sterile Mask) |
| ISO 10993-10 Irritation | No Irritation | No Irritation (Sterile Mask), No Irritation (Non-Sterile Mask) |
2. Sample size used for the test set and the data provenance
- Sample Size for performance tests (BFE, Particulate, Differential Pressure, Synthetic Blood): The reported results for BFE, Particulate Penetration, and Synthetic Blood are for 3 production lots. For Differential Pressure (non-sterile), N=32 is explicitly stated. For Synthetic Blood, 32/32 passes indicate a sample size of 32 per lot. For Flammability, 32/32 IBE also indicates a sample size of 32 per lot.
- Data Provenance: The tests are "Non-clinical tests" conducted to verify design specifications. The document states a "Summary of 510k safety and effectiveness information is being submitted." This implies the data is generated specifically for this submission and is likely from laboratory testing of the manufactured devices, not from real-world patient data. The manufacturer is HeNan YADU Industrial Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to the provided document. The "ground truth" for surgical masks refers to their measured physical and biological performance against standardized test methods (e.g., ASTM F2100, ISO 10993). These are objective laboratory measurements, not expert interpretations of clinical data. Therefore, experts establishing ground truth in the sense of medical diagnoses are not involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where a consensus among human experts is required for a diagnosis or finding. The performance of a surgical mask is determined by objective laboratory tests, not by expert adjudication.
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
This section is not applicable to the provided document. An MRMC study is relevant for evaluating the performance of AI/ML systems in conjunction with human readers, particularly in diagnostic imaging. This document describes a physical medical device (surgical mask) and does not involve AI assistance or human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable to the provided document. This refers to the performance of an AI algorithm operating independently of human input. The document describes a physical medical device (surgical mask) and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the surgical masks is established through objective laboratory measurements against recognized international and national standards (e.g., ASTM, EN, ISO). These standards define specific test methods and performance thresholds for bacterial filtration, particulate filtration, differential pressure, fluid resistance, flammability, and biocompatibility (cytotoxicity, sensitization, irritation).
8. The sample size for the training set
This section is not applicable to the provided document. Surgical masks are not AI/ML devices and therefore do not have "training sets."
9. How the ground truth for the training set was established
This section is not applicable to the provided document, as there is no training set for a surgical mask.
{0}------------------------------------------------
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 and 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.
March 14, 2022
HeNan YADU Industrial Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K212330
Trade/Device Name: YADU Surgical Masks (Model E (ear loops, sterile/non-sterile), Model T (tie on straps, sterile/non-sterile)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: February 9, 2022 Received: February 17, 2022
Dear Charles Shen:
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.
{1}------------------------------------------------
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.
For 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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212330
Device Name
Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/)
Indications for Use (Describe)
Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.
Type of Use (Select one or both, as applicable):
| Registration Use (Part 21 CFR 201.2 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201.2 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary-K212330:
This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92
1.0 Submitter Information
HeNan YADU Industrial Co., Ltd. No.234, West Jianpu Road 453400 Changyuan, Henan Province, CHINA Tel: (086) 373-2157057 Submitter's FDA Registration Number:3016452400
Submission Correspondent
Charles Shen Manton Business and Technology Services 37 Winding Ridge Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: March 13, 2022
2.0 Device Information
| Proprietary Name: | YADU Surgical Masks |
|---|---|
| Common Name: | Surgical Mask, Medical Face Mask |
| Models: | Model E (ear loop, sterile/non-sterile), Model T (tie on straps, sterile/non-sterile) |
3.0 Device Classification
| Classification Name: | Surgical Apparel |
|---|---|
| ---------------------- | ------------------ |
Classification Regulation: 21 CFR 878.4040 Class: Class II Product Code: FXX
4.0 Predicate Device Information:
| Manufacturer: | Hubei Xinxin Non-woven Co., Ltd. |
|---|---|
| Product Name: | Surgical Mask |
| 510(K)#: | K212120 |
{4}------------------------------------------------
5.0 Device description:
The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter.
Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex.
Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire.
The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions and are intended to be single use, disposable devices.
| Sterilization | Model |
|---|---|
| Non-sterile | Tie-on (Model T) |
| Ear loops (Model E) | |
| EO Sterile | Tie-on (Model T) |
| Ear loops (Model E) |
6.0 Indications for Use:
Y ADU Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.
7.1 Comparison to Predicate Devices
Y ADU Surgical Masks, manufactured by "HeNan YADU Industrial Co., Ltd." are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K212120, "Surgical Mask" Model XX009 Ear loop Level 1 and Model XX008 Tie-on Level 1, manufactured by "Hubei Xinxin Non-woven Co., Ltd."
{5}------------------------------------------------
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K212120) |
|---|---|---|
| Indicationfor Use | YADU Surgical Masks isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. It is intendedfor use in infection controlpractices to reduce the potentialexposure to blood and body fluids.This is a single use, disposabledevice, provided sterile and nonsterile. | The surgical masks are intendedto be worn to protect both thepatient and healthcare personnelfrom transfer ofmicroorganisms, body fluids,and particulate material. Thesemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. |
| Layers | Three | Three |
| Materials | Outer layer is made of 100%spun- bond polypropylene.Middle player is made of100%meltblownpolypropylene filter media.Inner layer is made of 100%spun- bond polypropylene.Ear-loops are made of polyesterand spandex.Ties are made from SpunbondPolypropyleneThe nose piece is iron and plastics | Outer layer is made of 100%spun- bond polypropylene.Middle player is made of100% meltblownpolypropylene filter media.Inner layer is made of 100%spun- bond polypropylene.Ear-loops are made ofspandexTies are made from SpunbondPolypropyleneThe nose piece is iron andplastics |
| Dimensions | 17.5 x 9.5cm | 17.5 x 9.5cm |
| Mask style | Flat Pleated | Flat Pleated |
| Design | Ear Loop and Tie-on Bands | Ear Loop (XX009) and Tie-on(XX008) |
| Color | Blue | Blue |
| Sterility | Sterile and Non-sterile | Non-sterile |
| Shelf life | Sterile: 3 yearsNon-sterile: None stated | Sterile: N/ANon-sterile: 2 years |
| Single Use | Yes | Yes |
| ASTMF2100 Level | Level 1 | Level 1 |
Table 1: Comparison of Intended Use, Design, and Material
{6}------------------------------------------------
The differences between the subject device and predicate device do not raise different questions of safety and effectiveness.
Non-Clinical Study Summary 8.1
Non-clinical 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:
- . Sterilization Validation: ISO-11135-1: 2014
- ASTM F2100: 2018 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F1862-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2299-03 (Reapproved 2017) Standard Test Method for Determining the ● Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- EN 14683-2019 Medical Face Masks Requirements and Test Methods ●
- In Vitro Cytotoxicity Test: ISO 10993-5: 2009 ●
- Skin Irritation Test: ISO 10993-10: 2010 ●
- Skin Sensitization Test: ISO 10993-10: 2010 ●
ASTM F2100 Testing for Level 1
| Table 2 - Sterile masks, ear loops, 3 years real time aged | |
|---|---|
| -- | ------------------------------------------------------------ |
| Name of the test | Purpose | AcceptanceCriteria | Results | ||
|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | |||
| ASTM F2101-19Bacterial FiltrationEfficiency (BFE) | To evaluate thebacterial efficiencyof the mask | $\geq$ 95% | 95.1-97.4% | 95.1-98.4% | 95.1-98.4% |
| ASTM F2299– 03(Reapproved 2017)Penetration byParticulates | To evaluate particlefiltration efficiencyof the mask | $\geq$ 95% | 95.1-97.9% | 95.1-99.6% | 95.1-97.4% |
{7}------------------------------------------------
| EN 14683-2019DifferentialPressure | To evaluatedifferentialpressure of thedevice | < 5.0 mmH2O/cm² | 3.7-4.2 | 3.7-4.1 | 3.7-4.1 | ||
|---|---|---|---|---|---|---|---|
| ASTM F1862-17Resistance topenetration bySynthetic Blood | To evaluateresistance topenetration bySynthetic Blood | Nopenetrationunder 80 mmHg | 32/32 pass | 32/32 pass | 32/32 pass |
Table 3 - Sterile masks, tie on straps, 3 years real time aged*
| Name of the test | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| 16 CFR part 1610 | Flammability | Class 1 | 32/32 IBE | 32/32 IBE | 32/32 IBE |
Table 4 - Non-sterile masks, ear loops, unaged
| Name of the test | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | |||
| ASTM F2101-19Bacterial FiltrationEfficiency (BFE) | To evaluate thebacterial efficiencyof the mask | ≥ 95% | 99.8-99.9% | 99.2-99.9% | 99.8-99.9% |
| ASTM F2299–03(Reapproved 2017)Penetration byParticulates | To evaluate particlefiltration efficiencyof the mask | ≥ 95% | 99.5 – 99.9% | 99.5 – 99.9% | 99.5 – 99.9% |
| EN 14683-2019DifferentialPressure | To evaluatedifferentialpressure of thedevice | < 5.0 mmH2O/cm2 | 3.1 – 3.6N=32 | 3.1 – 3.5N=32 | 3.0 – 3.N=32 |
| ASTM F1862-17Resistance topenetration bySynthetic Blood | To evaluateresistance topenetration bySynthetic Blood | Nopenetrationunder 80 mmHg | 32/32 pass | 32/32 pass | 32/32 pass |
Table 5 - Non-sterile mask, tie on straps, unaged*
| Name of the test | Purpose | AcceptanceCriteria | Results | ||
|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | |||
| 16 CFR part 1610 | Flammability | Class 1 | 32/32 IBE | 32/32 IBE | 32/32 IBE |
- Testing on masks with ear loops is representative of masks with tie on straps for all tests but flammability. Therefore, flammability was conducted on masks with tie on straps.
{8}------------------------------------------------
Table 6 – Biocompatibility
| Identification of test | Purpose | Acceptance criteria | Results Sterile Mask | Results Non-Sterile Mask |
|---|---|---|---|---|
| ISO 10993-5 | Assess the cytotoxicity of the mask | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity |
| ISO 10993-10 | Assess sensitization of the mask | No Sensitization | No Sensitization | No Sensitization |
| ISO 10993-10 | Assess irritation of the mask | No Irritation | No Irritation | No Irritation |
9.0 Clinical Study Summary
Clinical data is not needed for YADU Surgical Masks
10.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate 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.