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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is 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. The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/ AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user

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Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.

Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

powder-free surgeon's gloves that are disposable devices made of synthetic rubber

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

Nitrile Blue Powder-Free Examination Gloves

Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardin™ SMARTGOWN™ AIR Breathable Surgical Gown 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. The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.

Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.

The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. The closed back gowns are single use, disposable medical devices provided sterile and non-sterile. The non-sterile, closed back gowns are not intended for use in the operating room. The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. The open back gowns are single use, disposable medical devices provided non-sterile. The open back gown is nonprotective in the back. The open back gowns are not intended for use in the operating room.

The Cardinal Health™ ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are classified as Class II medical devices under Regulation 21 CFR 878.4040, General & Plastic Surgery Panel, FDA product code FYA, Surgical Gown. The ChemoPlus™ Full Coverage Closed Back and Open Back Gowns are made of a laminate with adhesive taped seams. Both closed and open back gowns have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.

The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 surgical masks are single use, disposable devices provided non-sterile.

The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.

The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Not intended for use in the operating room. The proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective. The Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use, disposable medical device provided non-sterile.

The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a Class II medical device under the FDA product code of FYC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Poly-Coated Open-Back Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015. The Cardinal Health™ Poly-Coated Open-Back Protective Gown consists of a laminate (blue spunbond polypropylene coated with polyethylene) throughout the body of the gown (including sleeves). The sleeves have a thumbhook cuff formed into the sleeve or have a knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer. The collar has a neck removal feature and the belt ties are integrated into the body. These gowns are non-sterile, single use, disposable gowns that are packaged in pastic bags and/or dispenser boxes. These gowns are offered in blue and come in both Universal and XX-Large sizes.

Cardinal Health™ Non-Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Cardinal Health™ Non-Reinforced Surgical Gowns are single use, disposable medical devices; provided sterile and non-sterile.

The Cardinal Health™ Non-Reinforced Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Non-Reinforced Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The chest front and sleeve critical zones of the Cardinal Health™ Non-Reinforced Surgical Gowns are constructed from a blue polyolefin SMS (spunbond, meltblown, spunbond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown. The Cardinal Health™ Non-Reinforced Surgical Gown is a single use, disposable medical device that will be provided in a variety of sterile and nonsterile packaging configurations.