Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small

Q: Who is the manufacturer of Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small?

Owens & Minor (O&M) Halyard, Inc. filed the 510(k) submission for Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small (K233022).

Q: What is the FDA product code for Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small?

MSH. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K233022 · Owens & Minor (O&M) Halyard, Inc. · MSH · Jan 12, 2024 · General, Plastic Surgery

Device Facts

Record ID	K233022
Device Name	Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
Applicant	Owens & Minor (O&M) Halyard, Inc.
Product Code	MSH · General, Plastic Surgery
Decision Date	Jan 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

The HALYARD FLUIDSHIELD N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Device Story

Surgical respirator consisting of nonwoven inner facing, filter media, fluid barrier film, and outer facing; covers nose and mouth; secured with two synthetic elastic headbands; includes malleable nosepiece. Used by operating room personnel and healthcare workers to provide barrier protection against microorganisms, blood, body fluids, and airborne particulates. Device is non-sterile and intended for single use. Provides physical barrier; performance validated via bench testing for filtration efficiency, fluid resistance, and breathability.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via NIOSH certification for filtration efficiency, ASTM F1862 for fluid resistance (120/160 mmHg), 16 CFR 1610 for flammability (Class I), and ISO 10993 series for biocompatibility (non-cytotoxic, non-sensitizing, non-irritating).

Technological Characteristics

Nonwoven inner/outer facing, filter media, fluid barrier film. Ultrasonic bonding. Synthetic elastic headbands, malleable nosepiece. NIOSH certified filtration. ASTM F1862 fluid resistance (120/160 mmHg). ISO 10993 biocompatibility. Non-sterile. Single-use.

Indications for Use

Indicated for operating room personnel and other health care workers to protect against transfer of microorganisms, blood, body fluids, and airborne particulates.

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

PFR95TM Particulate Filter Respirator and Surgical Mask Regular Size (K974068)

Related Devices

K974068 — PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL · Tecnol Medical Products, Inc. · Dec 22, 1997
K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S · 3M Healthcare · Aug 10, 2017
K970448 — PCM 2000; ISOLAIR APR MODEL 2735 · Tecnol Medical Products, Inc. · Apr 30, 1997
K063013 — PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S · Aearo Company · Dec 1, 2006
K960778 — ISOLAIR APR TYPE N95 · Louis M. Gerson Co., Inc. · May 9, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 12, 2024 Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116 # Re: K233022 Trade/Device Name: Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: MSH Dated: January 10, 2024 Received: January 10, 2024 Dear Anureet Singh: 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. {1}------------------------------------------------ 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" (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 QS 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 (OS) 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. 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Bifeng Qian -S Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233022 #### Device Name Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Fiter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small #### Indications for Use (Describe) The HALYARD FLUIDSHIELD N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## 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." {4}------------------------------------------------ # 510(k) Summary K233022 | 510(k) Owner: | O & M Halyard, Inc. 9120 Lockwood Boulevard Mechanicsville, VA 23116 Phone: 804-723-7000/800-488-8850 Fax: 804-723-7100 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Contact: | Anureet Singh Regulatory Affairs Manager | | Date of Summary: | 12 January 2024 | | Device Trade Name: | HALYARD* FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, HALYARD* FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, HALYARD* FLUIDSHIELD* 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | | Common Name: | Surgical Respirator | | Classification Name: | Surgical Respirator (21 CFR 878.4040, Product Code MSH) | | Predicate Device: | PFR95TM Particulate Filter Respirator and Surgical Mask Regular Size, K974068 | | Device Description: | Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece | ## Device Model Information: | Model Number | Name | Color | Size | ASTM F1862 | Individually Packaged | Dispenser Quantity | Case Quantity | |-----------------|---------------------------------------------------------------------------------------------------------------------------|--------|---------|---------------|--------------------------|-----------------------|------------------| | 46827 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 210 | | 76827 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 315 | | 46828 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical | Orange | Small | 160mmHg | Yes | 35 | 210 | | | Mask with SO SOFT* Lining | | | | | | | | 46867 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 210 | | 76867 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining | Orange | Small | 160mmHg | No | 35 | 315 | | 46727 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 210 | | 76727 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 315 | | 46728 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining | Orange | Regular | 160mmHg | Yes | 35 | 210 | | 46767 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 210 | | 76767 | FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining | Orange | Regular | 160mmHg | No | 35 | 315 | | 62355 | FLUIDSHIELD* 2 N95 Particulate | White | Small | 120mmHg | No | 50 | 300 | | | Filter Respirator and Surgical Mask with SO SOFT* Lining | | | | | | | | 62126 | FLUIDSHIELD* 2 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining | White | Regular | 120mmHg | No | 50 | 300 | {5}------------------------------------------------ {6}------------------------------------------------ Note: All devices are provided non-sterile The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Indication for Use: Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. Comparison of Device Technological Characteristics: | | Subject Device HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask (K233022) | Predicate Tecnol PFR95™ Particulate Filter Respirator and Surgical Mask (K974068) | Comparison Result | |-------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------| | Manufacturer | O&M Halyard, Inc. | Tecnol Medical Products, Incorporated | Different | | Device Model Numbers | 46827 & 76827 46828 46867 & 76867 46727 & 76727 46728 46767 & 76767 62355 62126 | 47119-110 47119-210 46717 46737 47119-114 47119-174 47119-214 47119-274 46817 46827 46837 46867 | Similar | | Common or Usual Name | Surgical Respirator | Surgical Respirator | Same | | Classification | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | Class | II | II | Same | | Product Code | MSH | MSH | Same | | Indication for Use | The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator | The PFR95™ Particulate Filter Respirator and Surgical Masks are intended | Similar | {7}------------------------------------------------ | Device Description and Materials | and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. | for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. | | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece. | Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece. | Same | | Method for Bonding | Ultrasonic | Ultrasonic | Same | | Distribution | Non-Sterile and Over-the- Counter | Non-Sterile and Over-the- Counter | Same | | Single Use Device | Yes | Yes | Same | Comparison of Specification Performance and Biocompatibility: | | Subject Device HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask (K233022) | Predicate Tecnol PFR95™ Particulate Filter Respirator and Surgical Mask (K974068) | Comparison Result | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------| | Filtration Efficiency | NIOSH certified | NIOSH certified | Same | | Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result, 160mmHg (Fluidshield 3 models: 46827, 76827, 46828, 46867, 76867, 46727, 76727) | Pass | Standard did not exist | Different | {8}------------------------------------------------ | 46728, 46767, 76767) ASTM F1862 Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result, 120mmHg (Fluidshield 2 models: 62355, 62126) ASTM F1862 | Pass | Standard did not exist | Different | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------|-----------| | Biocompatibility: Non-sensitizing Non-cytotoxic Non-irritating | Pass | Pass | Same | | Flame spread, Class I | Pass | Standard did not exist | Different | | Bacterial Filtration Efficiency ASTM F2101 | Pass BFE ≥ 98% | Standard did not exist | Different | | Particulate Filtration Efficiency ASTM F2299 | Pass PFE ≥ 98% | Standard did not exist | Different | Summary of Non-Clinical Performance Testing Performance Testing (Bench): | Performance Characteristic | Test Method | Acceptance Criteria | Result | |-------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------|--------| | Filtration Efficiency | TEB-APR-STP-0059 | Minimum efficiency for each filter of ≥95% (≤5% penetration) | Pass | | Breathability | TEB-APR-STP-0007 and TEB-APR-STP-0003 | Not exceeding 35mmH2O for TEB-APR-STP-0007, Not exceeding 25 mmH2O for TEB-APR-STP-0003 | Pass | | Fluid Resistance | ASTM F1862 | Pass at 120mmHg Pass at 160mmHg | Pass | | Flammability | 16 CFR 1610 | Class I Normal Flammability | Pass | | Biocompatibility | ISO 10993-5 L929 MEM Elution Test | < Grade 2 (mild reactivity) Non-cytotoxic | Pass | | Biocompatibility | ISO 10993-10 Guinea Pig Maximization test | No dermal erythemic response Non-sensitizing | Pass | {9}------------------------------------------------ | Biocompatibility | ISO 10993-23 Intracutaneous Injection Test | Difference between test article and control article overall mean score $ \leq $ 1 Non-irritating | Pass | |------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------|------| |------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------|------| Summary of Clinical Performance Testing: Not applicable. Conclusions: The conclusions drawn from the non-clinical tests demonstrate the subject device, the HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Tecnol PFR95TM Particulate Filter Respirator and Surgical Mask (K974068).

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