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The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose. The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.

The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.

The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose foam. These masks are single use, disposable devices, provided non-sterile.

Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM Level 1 (blue in color) Surgical and Procedure Mask(s). The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are a three-layer mask, constructed of non-woven materials. The Surgical Masks (28802) are provided with ties while the Procedure Masks (25869) are provided with earloops. A malleable nosepiece is placed within the bindings to conform with the wearer's nose. The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are single use, disposable devices, provided non-sterile.

The Fluidshield* 2 Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 2 Surgical Mask is a single use, disposable device, provided non-sterile. The Fluidshield* 2 Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 2 Procedure Mask is a single use, disposable device, provided non-sterile.

The subject device(s) are ASTM Level 2 Surgical and Procedure Mask(s). Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops and a malleable nosepiece. The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.

The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Procedure Masks are provided with earloops and a malleable nosepiece. The ASTM F2100 Level 1 Procedure Masks that are the subject of this submission are not provided with a fog-free foam or visor. These masks are single use, disposable devices, provided non-sterile.

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is a single use, disposable device, provided non-sterile.

The subject device is an ASTM F2100 Level 1 (green in color) Surgical Mask. The ASTM F2100 Level 1 Surgical Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties and a malleable nosepiece. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is provided with fog-free foam. These masks are single use, disposable devices, provided non-sterile.

Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.

The Halyard Tri-Layer AAMI 3 Isolation Gown ("Isolation Gown") is a single use gown, supplied non-sterile. The gowns come in the following sizes: Large, X-Large. These surgical gowns are apparel that are intended to be worn by healthcare professionals to protect from varying levels of fluid contact (low to moderate). These surgical gowns meet the AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, Level 3 Requirements. These Isolation Gowns are manufactured from three-layer full length polypropylene SMS material, with neck tape, elastic cuffs, and waist belt closure systems.

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 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

The Expanded Chamber Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber that are the subject of this submission are provided with a visor (39124). These masks are single use, disposable devices, provided non-sterile. The subject devices, the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124), are the same devices as cleared under K143287.

The subject devices are ASTM F2100 Level 2 (blue and white in color) Surgical Masks. The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) are a four- layer mask, constructed of well-known non-woven materials used in facial protection. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. When compared to a pleated/flat mask, the subject devices have a "duckbill" shape, which expands the volume of the chamber created when the mask is worn.