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The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following: - Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600. - 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C. - Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems. - Advanced Sterilization Products STERRAD 100S system - Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle] - Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle] PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for a maximum of 180 days or until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings: - 1- The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices. - 2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices. - 3-The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices. PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.

The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following: - Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600. - 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C. - Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems. - Advanced Sterilization Products STERRAD 100S system - Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle] - Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle] PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings: 1-The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices. 2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices. 3- The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices. PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

The PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.

The PRIMED level 1 Pediatric Facemask is a single use, disposable device intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to prevent the transmission of microorganism. PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not made with natural rubber latex.

PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material. The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only. PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below: - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal), - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL), - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Hook and Loop Closure (Universal, XL), - PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL), - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)

PRIMAGARD AAMI PB70:2012 Level 3 gowns are non-sterile, single use isolation gowns intended to be worn by healthcare professionals in isolations. These gowns are made of SMS non woven material, contain ultrasonic seams, provide full coverage (level 3 as per PB70) and are not made with natural rubber latex. The proposed isolation gowns come in 5 different models as described in the Indications for Use.

PRIMAGARD Delta Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and 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.

These surgical masks are deltoid shape, waterfall-pleated devices manufactured from selected non-woven materials (polypropylene and wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative to the degree of protection required during intended use.

PRIMAGARD™ Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedured to protect both the surgical patient and the operating room personnel from transfer of microcogniss is, body fluids, and particulate material. The PRIMAGARD™ Surgical Masks may also be worn outide of the operating room for non-surgical procedure use.

These surgical masks are rectangular, waterfall-pleated or soft-bill devices manufactured from selected non-woven materials (polypropylene or wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative, to the degree w of protection required during intended use.