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The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL. The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.

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The document describes the non-clinical testing and acceptance criteria for the "Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove" (K190159). The study aimed to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K082125).

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1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Specification	Standard / Test Method	Reported Device Performance
Performance Standards	ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application	Conforms
	ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves	Conforms
	ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves	Conforms
	ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves	Conforms (Shelf Life: 3 years, as noted in the technological comparison table, and this standard supports that determination).
	ASTM D412-15a Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension	Conforms (Indicated by compliance with ASTM D6319-10, which includes physical property requirements like tension).
Water Tightness	ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves	Conforms
	ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application	Conforms
	ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves	Conforms
Biocompatibility	ISO 10993-10 Skin Irritation Study	"Under the conditions of the study, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device is not a skin irritant."
	ISO 10993-10 Closed Patch Sensitization Study	"Under the conditions of the study, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device is not a contact sensitizer."
	ISO 10993-11 Acute Systemic Toxicity Study	"Under conditions of the ISO Acute Systemic Injection Test, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device does not present an acute toxicity potential."
Powder Residual	ASTM D6124-06 (acceptance criterion:

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