Stryker Steri-Shield 8 Surgical Hoods and Togas

K241272 · Stryker Instruments · FYA · Oct 16, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K241272
• Device Name: Stryker Steri-Shield 8 Surgical Hoods and Togas
• Applicant: Stryker Instruments
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Oct 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.

Device Story

Stryker Steri-Shield 8 Surgical Hoods and Togas are sterile, single-use surgical apparel components of the Stryker Steri-Shield 8 Personal Protection System. Hoods cover the user's head, neck, and shoulders; Togas cover the head, neck, arms, torso, and upper legs. Used in operating rooms by healthcare professionals to provide barrier protection against contamination, infectious bodily fluids, and particulate transfer. The device functions as a physical barrier; no electronic or software components are involved. Healthcare providers wear these during surgery to maintain a sterile field and protect themselves from exposure. Benefits include reduced risk of cross-contamination and infection transmission between patients and staff.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including flammability (16 CFR 1610), water resistance (AATCC 42), synthetic blood penetration (ASTM F1862), viral penetration (ASTM F1671), particulate/bacterial filtration (ASTM F2299, F2101), lint generation (ISO 9073-10), air permeability (ASTM D737), tear/tensile/seam strength (ASTM D5587, D5034, D1683), thermal/evaporative resistance (ASTM F1868), light transmittance (ASTM D1003), CO2 levels, and biocompatibility (ISO 10993 series).

Technological Characteristics

Materials: Polypropylene, polyester, polyethylene, acrylic, and PET/PC face shields. Construction: Non-woven fabrics (SMS, BVB, MB20). Sterilization: Ethylene Oxide (EO) per ISO 11135. Barrier performance meets AAMI/ANSI PB70 Level 4. Physical properties tested per ASTM standards for strength, filtration, and flammability.

Indications for Use

Indicated for healthcare personnel and patients in operating room environments requiring barrier protection against infectious bodily fluids, microorganisms, and particulate material.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Stryker T7 Surgical Hoods and Togas (K200493)

Submission Summary (Full Text)

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October 16, 2024

Stryker Instruments Susanne Galin Chief Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002

Re: K241272

Trade/Device Name: Stryker Steri-Shield 8 Surgical Hoods and Togas Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA, FXY Dated: May 6, 2024 Received: September 17, 2024

Dear Susanne Galin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Allan Guan -S

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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

Submission Number (if known)

K241272

Device Name

Stryker Steri-Shield 8 Surgical Hoods and Togas

#### Indications for Use (Describe)

The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.

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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# 510(k) Summary

### This Traditional 510(k) is submitted by:

| Address: | Stryker Instruments<br>1941 Stryker Way<br>Portage, MI 49002, USA |
|-------------------|-------------------------------------------------------------------|
| Telephone Number: | 269-389-2300 |
| 510(k) Number: | K241272 |
| Date Prepared: | October 16, 2024 |

#### Contact Information

| Contact Name: | Susanne Galin |
|---------------|-------------------------------------|
| Title: | Chief Regulatory Affairs Specialist |
| Email: | [e-mail] |

#### Device Information

| Device Proprietary Name | Stryker Steri-Shield 8 Surgical Hoods and Togas |
|-------------------------------------------|-------------------------------------------------|
| Device Common Names | Gown, Surgical; Hood, Surgical |
| Classification | Class II |
| Classification Product<br>Codes and Names | FYA- Gown, Surgical<br>FXY- Hood, Surgical |
| Classification Regulation | CFR 878.4040 |
| Review Panel | General Hospital |

#### Predicate Device

The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k):

| | Trade Name | 510(k) Number | Product<br>Code | Manufacturer |
|-----------|----------------------------------------|---------------|-----------------|---------------------|
| Predicate | Stryker T7 Surgical Hoods<br>and Togas | K200493 | FXY, FYA | Stryker Corporation |

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#### Device Description

The Stryker Steri-Shield 8 Surgical Protective Equipment consist of Stryker Steri-Shield 8 Surgical Hoods and Steri-Shield 8 Surgical Togas.

The Stryker Steri-Shield 8 Surgical Hood is a single piece device that covers the user's head, neck, and shoulder region and is intended to be worn with commercially available sterile surgical gowns. The Steri-Shield 8 Hoods are available with Standard (NPA), Peel Away (PA) and Anti-Reflective (AR) face shield options.

The Stryker Steri-Shield 8 Surgical Togas are a single piece device that covers the user's head, neck, arms, torso, and upper legs region. The Stryker Steri-Shield 8 Surgical Togas is offered in three configurations: Steri-Shield 8 Pullover Togas, Steri-Shield 8 Zippered Togas, and Steri-Shield 8 Tie Back Togas.

#### Indications for Use

The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.

#### Comparison to Predicate Device

| Characteristic | Subject Device:<br>Stryker Steri-Shield 8 Surgical<br>Hoods and Togas | Predicate Device:<br>Stryker T7 Surgical Hoods and<br>Togas (K200493) | Equivalence<br>Assessment |
|------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------|
| Proprietary<br>Name | Stryker Steri-Shield 8 Surgical<br>Hoods and Togas | Stryker T7 Surgical Hoods and<br>Togas | Branding<br>name, line<br>extension |
| Product<br>Classification/<br>Regulation | Class II<br>21 CFR 878.4040<br>Surgical Apparel | Class II<br>21 CFR 878.4040<br>Surgical Apparel | Identical |
| FDA Product<br>Codes | FXY, FYA | FXY, FYA | Identical |

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Image /page/6/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly blurred, but still legible. The font is modern and clean, and the overall effect is professional.

| Indications for<br>Use Statement | The Stryker Steri-Shield 8<br>disposables, including all hood<br>and toga models, are<br>components of the Stryker<br>Steri-Shield 8 Personal<br>Protection System and are<br>intended to protect the patient,<br>healthcare personnel, and<br>operating room personnel<br>against contamination,<br>exposure of infectious bodily<br>fluids, and the transfer of<br>microorganism and particulate<br>material. The Stryker Steri-<br>Shield 8 disposables are sterile,<br>disposable, single-use only<br>devices. | The Stryker T7 Surgical<br>Personal Protective Equipment<br>Hoods and Togas are<br>components of Stryker T7<br>Personal Protective Equipment<br>(PPE). These surgical devices<br>are intended to protect the<br>patient, health care personnel<br>and operating room personnel<br>against contamination,<br>exposure of infectious bodily<br>fluids, and the transfer of<br>microorganism and particulate<br>material. The Stryker T7<br>Surgical Personal Protective<br>Equipment Hoods and Togas<br>are sterile, single use only<br>devices. | Identical<br>(except for<br>branding) |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Primary User<br>Population | Healthcare Professional<br>operating within an<br>environment requiring<br>barrier protection. | Healthcare Professional<br>operating within an<br>environment requiring<br>barrier protection. | Identical |
| Hood and Toga<br>Models | Hood, Pullover Toga,<br>Zippered Toga, Tie Back<br>Toga | Hood, Pullover Toga,<br>Zippered Toga | Similar |
| Characteristic | Subject Device:<br>Stryker Steri-Shield 8 Surgical<br>Hoods and Togas | Predicate Device:<br>Stryker T7 Surgical Hoods and<br>Togas (K200493) | Equivalence<br>Assessment |
| Shelf Life | 1.5 years | 3 years | Different |
| Available Sizes | Hood Single Size Only<br>Toga: Large, X Large, 2X<br>Large, 3X Large | Hood Single Size Only<br>Toga: Large, X Large, 2X<br>Large, 3X Large | Identical |
| Conditions for<br>Use | Single Use Only | Single Use Only | Identical |
| Raw Materials | | | |
| Face Shield<br>Standard | Clear PC | Clear PC | Identical |
| Face Shield Peel<br>Away | Clear PET Laminate | Clear PET Laminate | Identical |
| Face Shield<br>Anti-Reflective | Clear PET with Anti-Reflective<br>Coating | Clear PET with Anti-Reflective<br>Coating | Identical |
| Hood Side/Back | MB20:<br>Electrostatically charged<br>melt blown polypropylene<br>with spunbond scrim on<br>both sides | MB20:<br>Electrostatically charged<br>melt blown polypropylene<br>with spunbond scrim on<br>both sides | Identical |
| Filter Material | Polypropylene and Acrylic;<br>TS030Plus | Polypropylene and Acrylic;<br>TS050Plus | Similar |
| Hood Front | BVB - trilaminate with<br>polyethylene and polyester<br>outer layers with monolithic<br>film in the middle | BVB - trilaminate with<br>polyethylene and polyester<br>outer layers with monolithic<br>film in the middle | Identical |
| Toga Bodice<br>Back Panel | SMS: Tri-laminate<br>polypropylene nonwoven fabric<br>with layers of spunbond,<br>meltblown and spunbond | SMS: Tri-laminate<br>polypropylene nonwoven fabric<br>with layers of spunbond,<br>meltblown and spunbond | Identical |
| Toga Front | BVB - trilaminate with<br>polyethylene and polyester<br>outer layers with monolithic<br>film in the middle | BVB - trilaminate with<br>polyethylene and polyester<br>outer layers with monolithic<br>film in the middle | Identical |
| Toga Sleeves | BVB - trilaminate with<br>polyethylene and polyester<br>outer layers with monolithic<br>film in the middle | BVB - trilaminate with<br>polyethylene and polyester<br>outer layers with monolithic<br>film in the middle | Identical |
| Toga Sleeve<br>Cuffs | 100% Type 310<br>Polyester | 100% Type 310<br>Polyester | Identical |
| Thread | Polyester | Polyester | Identical |
| Characteristic | Subject Device:<br>Stryker Steri-Shield 8 Surgical<br>Hoods and Togas | Predicate Device:<br>Stryker T7 Surgical Hoods and<br>Togas (K200493) | Equivalence<br>Assessment |
| Weave and<br>Thread Count | All materials are non-<br>woven | All materials are non-<br>woven | Identical |
| Barrier Performance | | | |
| Critical Zone<br>Barrier<br>Performance:<br>Gown | ASTM F1671 testing - BVB &<br>Sleeve Seam: passes<br>requirements for PB70 Level 4<br>protection | ASTM F1671 testing - BVB &<br>Sleeve Seam: passes<br>requirements for PB70 Level 4<br>protection | Both meet<br>acceptance<br>criteria |
| Non-Critical<br>Barrier<br>Performance:<br>Gown | All materials and seams of<br>Togas pass AATCC Test<br>Method 42 Per AAMI/ANSI<br>PB70 (<4.5g) | All materials and seams of<br>Togas pass AATCC Test<br>Method 42 Per AAMI/ANSI<br>PB70 (<4.5g) | Both meet<br>acceptance<br>criteria |
| Exempt Barrier<br>Performance:<br>Hood | All materials and seams are<br>non-protective | All materials and seams are<br>non-protective | Both meet<br>acceptance<br>criteria |
| Physical Performance | | | |
| Flammability<br>per 16 CFR Part<br>1610 | Class 1 | Class 1 | Both meet<br>acceptance<br>criteria |
| Water Spray<br>Impact per<br>AATCC42 | AATCC Test Method 42:<br>Water Penetration ≤ 4.5 g | AATCC Test Method 42:<br>Water Penetration ≤ 4.5 g | Both meet<br>acceptance<br>criteria |
| Synthetic Blood<br>per ASTM<br>F1862 | No visible penetration | No visible penetration | Both meet<br>acceptance<br>criteria |
| Fabric Viral<br>Penetration per<br>ASTM F1671 | ASTM F1671, Procedure B:<br>no detectable (< 1 PFU/mL) | ASTM F1671, Procedure B:<br>no detectable (< 1 PFU/mL) | Both meet<br>acceptance<br>criteria |
| Particulate<br>Filtration<br>Efficiency per<br>ASTM F2299 | ≥ 95% | ≥ 95% | Both meet<br>acceptance<br>criteria |
| Bacterial<br>Filtration | ≥ 95% | ≥ 95% | Both meet<br>acceptance<br>criteria |
| Characteristic | Subject Device:<br>Stryker Steri-Shield 8 Surgical<br>Hoods and Togas | Predicate Device:<br>Stryker T7 Surgical Hoods and<br>Togas (K200493) | Equivalence<br>Assessment |
| Efficiency per<br>ASTM F2101 | | | |
| Particle Release<br>per ISO 9073-10 | Lint Count ≤ 4.0 (Log10, Upper<br>Quartile) | Lint Count ≤ 4.0 (Log10, Upper<br>Quartile) | Both meet<br>acceptance<br>criteria |
| Air Permeability<br>per ASTM D737 | Better or equivalent to<br>predicate product | Better or equivalent to<br>predicate product | Both meet<br>acceptance<br>criteria |
| Tear Strength<br>per ASTM<br>D5587 | ≥ 2.3lbf | ≥ 2.3lbf | Both meet<br>acceptance<br>criteria |
| Tensile<br>Strength per<br>ASTM D5034 | ≥ 7.0lbf | ≥ 7.0lbf | Both meet<br>acceptance<br>criteria |
| Seam Strength<br>per ASTM<br>D1683 | ≥ 7.0lbf | ≥ 6.0lbf | Both meet<br>acceptance<br>criteria |
| Evaporative<br>Resistance per<br>ASTM F1868 | Better or equivalent to<br>predicate product | Better or equivalent to<br>predicate product | Both meet<br>acceptance<br>criteria |
| Light<br>Transmittance<br>and Haze per<br>ASTM D1003 | Better or equivalent to<br>predicate product | Better or equivalent to<br>predicate product | Both meet<br>acceptance<br>criteria |
| Finished<br>(Terminal)<br>Product<br>Sterilization<br>Method | SAL 10-6 Terminally sterilized<br>via Ethylene Oxide (EO) in<br>accordance with ISO 11135,<br>Half cycle overkill method | SAL 10-6 Terminally sterilized<br>via Ethylene Oxide (EO) in<br>accordance with ISO 11135,<br>Half cycle overkill method | Identical |
| Packaging<br>Configuration | Individually packaged in a<br>Poly-Tyvek pouch | Individually packaged in a<br>Poly-Tyvek pouch | Identical |
| Labeling | Adhesive backed label<br>placed on carton and<br>pouch label printed<br>directly onto the Tyvek.<br>Label specifies part<br>description, quantity,<br>sterilization method, lot | Adhesive backed label<br>placed on carton and<br>pouch label printed<br>directly onto the Tyvek.<br>Label specifies part<br>description, quantity,<br>sterilization method, lot | Identical |
| Characteristic | Subject Device:<br>Stryker Steri-Shield 8 Surgical<br>Hoods and Togas | Predicate Device:<br>Stryker T7 Surgical Hoods and<br>Togas (K200493) | Equivalence<br>Assessment |
| | number, expiration date,<br>and contact information. | number, expiration date,<br>and contact information. | |

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#### Performance Data (Non-Clinical Tests)

The following table provides an overview of the standards and testing conducted in accordance with FDA Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued August 1993 and applicable recognized and published standards to aid in determination of the subject devices as safe and effective for use and to support a determination of substantial equivalence.

| Testing Standard with Year | Acceptance Criteria | Test<br>Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-----------------|
| Standard for the Flammability of Clothing<br>Textiles (16 CFR Part 1610:2023) | Meets Class 1 requirements | Pass |
| Water Resistance: Impact Penetration Test<br>(AATCC 42-2017) | Water Penetration ≤ 4.5 grams | Pass |
| Standard Test Method for Resistance of<br>Medical Face Masks to Penetration by<br>Synthetic Blood (Horizontal Projection of Fixed<br>Volume at a Known Velocity) (ASTM<br>F1862/F1862M-2017) | No visible penetration | Pass |
| Standard Test Method for Resistance of<br>Materials Used in Protective Clothing to<br>Penetration by Blood-Borne Pathogens Using<br>Phi-X174 Bacteriophage Penetration as a Test<br>System (ASTM F1671-2022) | < 1 PFU/mL | Pass |
| Standard Test Method for Determining the<br>Initial Efficiency of Materials to Penetration by<br>Particulates Using Latex Spheres (ASTM F2299-<br>2017) | ≥ 95% | Pass |
| Standard Test Method for Evaluating the<br>Bacterial Filtration Efficiency (BFE) of Medical<br>Face Mask Materials (ASTM F2101-2022) | ≥ 95% | Pass |
| Textiles. Test methods for nonwovens-Lint and<br>other particles generation in the dry state (ISO<br>9073-10:2004) | Lint Count ≤ 4.0 ( $Log$ 10, Upper Quartile) | Pass |
| Standard Test Method for Air Permeability of<br>Textile Fabrics (ASTM D737-2018) | Better or equivalent to predicate product | Pass |

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| Standard Test Method for Tearing Strength of<br>Fabrics by Trapezoid Procedure (ASTM D5587-<br>2019) | $\ge 2.3lbf$ | Pass |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------|
| Standard Test Method for Breaking Strength<br>and Elongation of Textile Fabrics (Grab Test)<br>(ASTM D5034-2021) | $\ge 7.0lbf$ | Pass |
| Standard Test Method for Failure in Sewn<br>Seams of Woven Fabrics (ASTM<br>D1683/D1683M-17(2018)) | $\ge 7.0lbf$ | Pass |
| Standard Test Method for Thermal Resistance,<br>Evaporative Resistance, and Total Heat Loss<br>Measurements of Clothing Materials Using a<br>Sweating Hot Plate (ASTM F1868-2017) | Better or equivalent to predicate product | Pass |
| Standard Test Method for Haze and Luminous<br>Transmittance of Transparent Plastics (ASTM<br>D1003-2021) | Better or equivalent to predicate product | Pass |
| Perforation Tear Strength Testing (Stryker<br>Internal Testing) | $0.15lbf < Tear Force \le 1.5lbf$ | Pass |

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Image /page/12/Picture/1 description: The image shows the word "stryker" in bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is positioned horizontally and appears to be a logo or brand name.

| Human Factors and Usability | Product is found to be safe and effective for the intended users, uses and use environment while following Agency "Human Factors and Usability Engineering to Medical Devices" guidance. | Pass |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Noise and Speech Interference Levels | Better or equivalent to predicate product | Pass |
| Carbon Dioxide (CO2) Testing | Inhale CO2 $\le$ 5000ppm per OSHA Exposure Limits | Pass |
| Biological Evaluation of Medical Devices – Part<br>1: Evaluation and testing within a risk<br>management process (ISO 10993-1:2018)<br>Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity (ISO 10993-5:2009) Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO 10993-10:2021) Biological evaluation of medical devices – Part 23: Test for irritation (ISO 10993-23:2021) Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2017) | Cytotoxicity – MEM Grade $\le$ 2 Sensitization – Sensitization response $\le$ 0 Irritation – Intracutaneous Reactivity $\le$ 1.0 Acute Systemic Toxicity – No signs of toxicity, no weight loss in excess of 10% | Pass* |
| Biological evaluation of medical devise - Part<br>17: Toxicological risk assessment of medical<br>device constituents (ISO 10993-17:2023) | Assessment performed | Comply |
| Biological evaluation of medical devices – Part<br>18: Chemical characterization of medical<br>device materials within a risk management<br>process (ISO 10993-18: 2020) | Characterization performed | Comply |

*Test article Zippered Toga with Peel-Away Face Shield showed a cytotoxic response under the test. However, in vivo testing and chemical characterization (extractables and simulated use extractables) were completed and serve to mitigate the in vitro cytotoxicity result observed in the MEM elution assay to support the biocompatibility of the subject article.

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## Summary of Clinical Testing

No clinical testing was performed for the subject device.

#### Conclusion/ Substantial Equivalence Rationale

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Stryker Steri-Shield 8 Surgical Hoods and Togas, is as safe, as effective, and performs as well as or better than the legally marketed predicate device under K200493.