(120 days)
The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material. The togas are sterile and single use only.
The Steri-Shield Flyte Hybrid Togas are single use, sterile, disposable devices that comprise part of the Steri-Shield Flyte Hybrid Personal Protection System. They are intended to be worn by healthcare personnel to protect the patient and healthcare personnel against contamination, exposure of infectious bodily fluids and the transfer of microorganisms and particulate material. The devices are prescription use.
The provided FDA 510(k) summary for the Stryker Steri-Shield Flyte Hybrid Togas describes performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria per se. The context is a "Special 510(k): Device Modifications with no change to fundamental scientific technology or intended use."
The document focuses on comparing the modified device (Stryker Steri-Shield Flyte Hybrid Togas) to its predicate device (Stryker Steri-Shield Flyte Togas, K073017) across various specifications and explicitly states that the "Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Steri-Shield Flyte Hybrid Togas are sufficient for their intended use and support a determination of substantial equivalence."
Key points from the provided text:
-
Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" but rather presents a comparison table where the subject device's performance is listed against the predicate device's performance, often with "Compliant - Pass" as the reported result for both. The "Explanation of Difference" column clarifies if the subject device meets the same specifications, even if materials or test standards changed.
Acceptance Criteria (Implied / Specification Met) Reported Device Performance (Stryker Steri-Shield Flyte Hybrid Togas) Biocompatibility: Non-cytotoxic Non-cytotoxic Biocompatibility: Non-sensitizing Non-sensitizing Biocompatibility: Negligible irritant Not an irritant Sterility Assurance Level (SAL) 10⁻⁶ Lint Level (ISO 9073 part 10) Compliant - Pass Tensile Strength (BS EN 29073-3) Compliant - Pass Tear Resistance (ASTM D 5587-08) Compliant - Pass Evaporative Resistance (ASTM F 1868) Compliant - Pass Bacterial Filtration Efficiency (ASTM F2101-07) Compliant - Pass Particulate Filtration Efficiency (ASTM F2299-03) Compliant - Pass Viral Penetration (ASTM F1671) Level 4 (Critical Zone) Front/Sleeve material: Pass requirements for Level 4 Protection. Sleeve Seam: Pass requirements for Level 4 Protection. (Note: Hood region material not designed to meet Level 4) Water Resistance: Impact Penetration (AATCC 42) Level 1 (Critical Zone) Hood region material: Pass requirements for Level 1 Protection. Back material: Pass requirements for Level 1 Protection. All other protective seams: Pass requirements for Level 1 Protection. Flammability (16 CFR Part 1610) No Flame Spread Shelf Life (initial submission) 1 year (with intent to extend upon further studies) -
Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for each performance test. It only states "Results of performance testing demonstrate..." without numerical data on the number of units tested.
The data provenance is not explicitly stated beyond being "performance testing" conducted by Stryker Instruments. It is prospective testing performed to support the 510(k) submission for the modified device. There is no mention of country of origin for the data. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this type of device and study. The testing described is primarily physical, mechanical, and biological performance testing against recognized standards (e.g., ISO, ASTM, AAMI, AATCC, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy, for example. The "truth" is whether the material or assembled device meets the specified performance metrics in the standards. -
Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation of outputs (e.g., imaging devices with radiologists). The Stryker Steri-Shield Flyte Hybrid Togas are surgical apparel, and their effectiveness is evaluated through physical and biological barrier properties, not diagnostic accuracy or human interpretation. -
Standalone Performance:
Yes, a standalone performance assessment was done. The performance testing (biocompatibility, sterility, lint level, tensile strength, tear resistance, evaporative resistance, bacterial filtration, particulate filtration, viral penetration, water resistance, flammability, shelf life) evaluates the intrinsic properties and performance of the device itself, separate from human interaction or interpretation beyond fitting and use. -
Type of Ground Truth Used:
The "ground truth" used is defined by established international and national standards for medical devices and textiles, such as:- ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation of Medical Devices)
- ANSI/AAMI/ISO 11135-1:2007 (Sterilization)
- ISO 9073 part 10 (Lint Level)
- BS EN 29073-3 (Tensile Strength)
- ASTM D 5587-08 (Tear Resistance)
- ASTM F 1868 (Evaporative Resistance)
- ASTM F2101-07 (Bacterial Filtration Efficiency)
- ASTM F2299-03 (Particulate Filtration Efficiency)
- ASTM F1671 (Viral Penetration)
- AATCC 42 (Water Resistance: Impact Penetration)
- 16 CFR Part 1610 (Flammability)
The device performance is compared against the requirements specified in these standards.
-
Sample Size for the Training Set:
This information is not applicable. This device is not an AI/ML algorithm that requires a training set for model development. The modifications are material changes and dimensional adjustments for physical apparel. -
How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
August 26, 2014
Stryker Instruments Ms. Julia L. Helgeson Senior Regulatory Representative 4100 E. Milham Ave Kalamazoo, MI 49001
Re: K141095
Trade/Device Name: Stryker Steri-Shield Flyte Hybrid Togas Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: July 30, 2014 Received: July 31, 2014
Dear Ms. Helgeson.
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. 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 mav 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
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 Indications for Use Statement
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141095
Device Name Styker Steri-Shield Flyte Hybrid Togas
Indications for Use (Describe)
The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The togas are sterile and single use only.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
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4100 E. Milham Ave.
Kalamazoo, MI 49001
t: 269 329 7000 f: 269 389 5412 www.stryker.com
510(k) Summary
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-329-7000(f) 269-389-5412 | ||||
|---|---|---|---|---|---|
| Contact Person: | Julia L. HelgesonSr. Regulatory Affairs Representative | ||||
| Registration Number: | 1811755 | ||||
| Date Summary Prepared: | June 25, 2014 | ||||
| Trade Name(s): | Stryker Steri-Shield Flyte Hybrid Togas | ||||
| Common Name: | Surgical Apparel | ||||
| Classification Data: | Product Code | Device | RegulationNumber | Class | ReviewPanel |
| FYA | Gown, Surgical | 21 CFR 878.4040 | ll | General &PlasticSurgery | |
| Reason for 510(k)Submission: | Special 510(k): Device Modifications with no change to fundamental scientifictechnology or intended use. | ||||
| Device Modification: | Stryker submits this Special 510(k): Device Modification for our Steri-Shield FlyteTogas. The modifications are as follows: | ||||
| Change in material utilized in hood region of toga●Change in material formulation of barrier material●Dimensional changes for user fit●Minor design modifications to component attachment methods● | |||||
| The modification changes neither the intended use, the indications for use, nor thefundamental scientific technology. | |||||
| Predicate SE Device(s): | Stryker Steri-Shield Flyte Togas (K073017) | ||||
| Indications for Use: | The Stryker Steri-Shield Flyte Hybrid Togas are components of a personalprotection system and are intended to protect the patient, healthcare personnel,and operating room personnel against contamination, exposure of infectious bodilyfluids, and the transfer of microorganisms and particulate material. The togas aresterile and single-use only. | ||||
| Device Description: | The Steri-Shield Flyte Hybrid Togas are single use, sterile, disposable devices thatcomprise part of the Steri-Shield Flyte Hybrid Personal Protection System. They areintended to be worn by healthcare personnel to protect the patient and healthcare |
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4100 E. Milham Ave. Kalamazoo, MI 49001 t: 269 329 7000 f: 269 389 5412 www.stryker.com
Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The word is in black and the background is white.
personnel against contamination, exposure of infectious bodily fluids and the transfer of microorganisms and particulate material. The devices are prescription use.
Device Models:
| Description | Part Numbers |
|---|---|
| Stryker Steri-Shield Flyte Hybrid Zippered Togas,Standard Lens | 0408-8X1-000 Series |
| Stryker Steri-Shield Flyte Hybrid Zippered Togas, PeelAway Lens | 0408-8X1-100 Series |
| Stryker Steri-Shield Flyte Hybrid Pullover Togas | 0408-7X1-000 Series |
Results of performance testing demonstrate that the functionality, integrity, and Performance Data (Non safety and effectiveness of the Steri-Shield Flyte Hybrid Togas are sufficient for Clinical Tests): their intended use and support a determination of substantial equivalence.
Summary of Performance Testing
Biocompatibility testing was performed on the subject device in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological Evaluation of Medical Devices-Part 1: Evaluation and AAMI Standards and Recommended Practices, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices. Results of testing validate the subject device is non-cytotoxic, non-sensitizing, and a negligible irritant.
Stryker Steri-Shield Flyte Hybrid Togas will be available only in sterile packaged form. The sterile product will be terminally sterilized using ethylene oxide (EO). The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide. A sterility assurance level of 10 ° has been validated for this product.
Comparison to Predicate Device:
| Description | Stryker Steri-Shield FlyteTogas (K073017)(Predicate) | Stryker Steri-Shield FlyteHybrid Togas(Subject) | Explanation of Difference |
|---|---|---|---|
| Classification/Regulation | Class II | Class II | Identical |
| Regulation | 21 CFR 878.4040 SurgicalApparel | 21 CFR 878.4040 SurgicalApparel | Identical |
| Product Code | FYA | FYA | Identical |
| Description | Stryker Steri-Shield FlyteTogas (K073017)(Predicate) | Stryker Steri-Shield FlyteHybrid Togas(Subject) | Explanation of Difference |
| Intended Use | The Stryker Steri-Shield FlyteTogas are components of apersonal protection systemand are intended to protectthe patient, health carepersonnel and operatingroom personnel againstcontamination, exposure ofinfectious bodily fluids, thetransfer of microorganismsand particulate materials. | The Stryker Steri-Shield FlyteHybrid Togas are componentsof a personal protectionsystem and are intended toprotect the patient, health carepersonnel and operating roompersonnel againstcontamination, exposure ofinfectious bodily fluids, thetransfer of microorganisms andparticulate materials.The togas are sterile and singleuse only. | Identical |
| Target Population | Operating room personnel | Operating room personnel | Identical |
| Conditions for Use | Single Use/Disposable | Single Use/Disposable | Identical |
| Materials | |||
| Hood Region | Polypropylene and polyester | Polypropylene | Steri-Shield Flyte Hybridproducts utilizes a morebreathable material inthe hood region. |
| Filter | Polypropylene and Acrylic | Polypropylene and Acrylic | Identical |
| Lens: Standard(Non-Peelaway) | Clear Polycarbonate | Clear Polycarbonate | Identical |
| Lens: Peelaway | Clear PET Laminate | Clear PET Laminate | Identical |
| Front and Sleeves(Barrier Material) | Polypropylene and polyester | Polypropylene and polyester | Similar. Steri-Shield FlyteHybrid front and sleevesuse an improved grade ofthe material, whichincreases manufacturingefficiencies. |
| Back and ShoulderTies | polypropylene | polypropylene | Identical |
| Waist Ties | Polypropylene and polyester | Polypropylene and polyester | Identical |
| Cuffs | Polyester | Polyester | Identical |
| Zipper | Polyester, Nylon, and Vinyl | Polyester, Nylon, and Vinyl | Identical |
| Zipper Guard | polypropylene | polypropylene | Identical |
| Color | Hood region material: BlueFront/Sleeve material: Blue | Hood region material: LightblueFront/Sleeve material: Blue | Similar. Steri-Shield FlyteHybrid hood regionmaterial is light blue incolor instead of blue. |
| Back material: BlueFilter material: White | Back material: BlueFilter material: White | ||
| Physical/ Mechanical Specifications | Cuffs: White | Cuffs: White | |
| Description | Stryker Steri-Shield FlyteTogas (K073017)(Predicate) | Stryker Steri-Shield FlyteHybrid Togas(Subject) | Explanation of Difference |
| Lint Level (ISO 9073part 10 ) | Compliant - Pass | Compliant - Pass | Specification met. Steri-Shield Flyte Hybrid Togasuse a different hoodregion material. The filtermaterial was not testedas part of the initial 510kbut was tested for theSteri-Shield Flyte Hybrid510k. |
| Tensile Strength (BSEN 29073-3) | Compliant - Pass | Compliant - Pass | Specification met. Steri-Shield Flyte Hybrid hoodregion material has alower tensile strength,but it still meets thespecification. The filtermaterial was not testedas part of the initial 510kbut was tested for theSteri-Shield Flyte Hybrid510k. |
| Tear Resistance(Flyte Hybrid: ASTMD 5587-08; Flyte:ASTM D 5733) | Compliant - Pass | Compliant - Pass | Specification met. ASTMD5733 was withdrawn in2008; therefore, adifferent test standardswere followed. The filtermaterial was not testedas part of the initial 510k,but was tested for theSteri-Shield Flyte Hybrid510k. |
| Evaporativeresistance (ASTM F1868 ) | Not Previously Tested | Compliant - Pass | Specifications met.Evaporative Resistancewas not previously testedas part of the initial Steri-Shield Flyte 510k. |
| Bacterial FiltrationEfficiencyper ASTM F2101-07 | Compliant - Pass | Compliant - Pass | Specifications met. |
| Particulate FiltrationEfficiencyper ASTM F2299-03 | Compliant - Pass | Compliant - Pass | Specifications met. |
| Description | Stryker Steri-Shield FlyteTogas (K073017)(Predicate) | Stryker Steri-Shield FlyteHybrid Togas(Subject) | Explanation of Difference |
| Viral Penetration(per ASTM F1671)Level 4 Critical Zoneas defined inAAMI/ANSI PB70 | Hood region material: Passrequirements for Level 4Protection. | Hood region material: Materialnot designed to meet Level 4protection and was not testedfor viral penetration | Specifications met. |
| Front/Sleeve material: Passrequirements for Level 4Protection. | Front/Sleeve material: Passrequirements for Level 4Protection. | ||
| Sleeve Seam: Passrequirements for Level 4Protection. | Sleeve Seam: Passrequirements for Level 4Protection. | ||
| Water Resistance:Impact Penetration(per AATCC 42)Level 1 Critical Zone | Hood region Material: Passrequirements for Level 1Protection. | Hood region Material: Passrequirements for Level 1Protection. | Specifications met. |
| as defined inAAMI/ANSI PB70 | Back material: Passrequirements for Level 1Protection. | Back material: Passrequirements for Level 1Protection. | |
| All other protective seams:Pass requirements for Level 1Protection. | All other protective seams:Pass requirements for Level 1Protection. | ||
| General Safety and Performance | |||
| Biocompatibility | |||
| in vitro cytotoxicity | Under the conditions of thestudy, non-cytotoxic | Under the conditions of thestudy, non-cytotoxic | Identical |
| primary skinirritation | Under the conditions of thestudy, not an irritant | Under the conditions of thestudy, not an irritant | Identical |
| skin sensitization | Under the conditions of thestudy, not a sensitizer | Under the conditions of thestudy, not a sensitizer | Identical |
| Flammability | No Flame Spread per 16 CFRPart 1610 | No Flame Spread per 16 CFRPart 1610 | Identical |
| Shelf Life | 3 years | 1 year | Similar – the intent is toextend the shelf life forthe subject device uponsuccessful completion ofaging studies |
| Finished (Terminal)Product SterilizationMethod | SAL 10-6Terminally sterilized viaEthylene Oxide in accordancewith ISO 11135-1 | SAL 10-6Terminally sterilized viaEthylene Oxide in accordancewith ISO 11135-1 | Identical |
| Packaging | Individually packaged in aPoly-Tyvek pouch | Individually packaged in a Poly-Tyvek pouch | Identical |
| Description | Stryker Steri-Shield FlyteTogas (K073017)(Predicate) | Stryker Steri-Shield FlyteHybrid Togas(Subject) | Explanation of Difference |
| Labeling | Adhesive backed label placedon carton and pouch labelprinted directly onto theTyvek.Label specified partdescription, quantity,sterilization method, lotnumber, expiration date, andcontact information.No known contraindications. | Adhesive backed label placedon carton and pouch labelprinted directly onto the Tyvek.Label specified partdescription, quantity,sterilization method, lotnumber, expiration date, andcontact information.No known contraindications. | Identical |
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Image /page/6/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The word is all in lowercase letters except for the first letter, which is capitalized. A small registered trademark symbol is located to the upper right of the letter "r" at the end of the word. The word is in black and the background is white.
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Image /page/7/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. A small registered trademark symbol is located to the upper right of the letter "r".
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Image /page/8/Picture/1 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a distinctive font. The word "Stryker" is written in all lowercase letters, with the "r" having a unique curved shape. A registered trademark symbol is located to the upper right of the "r".
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Image /page/9/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all connected, and the word is in black. There is a registered trademark symbol to the right of the letter "r". The logo is simple and modern.
Conclusion/ Substantial Equivalence (SE) Rationale:
The Stryker Steri-Shield Flyte Hybrid Togas are substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker Steri-Shield Flyte Togas. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications introduced raise no new issues of safety and effectiveness. Therefore, the Stryker Steri-Shield Flyte Hybrid Togas are substantially equivalent to the existing predicate devices.
§ 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.