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A latex surgeon's gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

The proposed device, Latex Surgeon's Gloves Powdered and Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577-09. The rubber surgical gloves classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and the come in different sizes ( 5½, 6, 6½, 7, 7½, 8, 8½, 9 ). All gloves share the same color, creamy white and all have beaded cuff and textured at the finger tips and palm. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10th and place in a sterility maintenance package to ensure a shelf life of 3 years.

AI/ML Overview

This appears to be a 510(k) summary for a medical device (latex surgeon's gloves), not a study specifically designed to assess an AI/ML device or its performance against acceptance criteria in the way typically expected for such technologies. Therefore, many of the requested elements (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not detailed in this document.

However, I can extract the acceptance criteria and demonstrated performance for the physical and biological characteristics of the surgeon's gloves, as described in the "Product Comparison in Compliance with ASTM D 3577-09 Standard" and "Technological Characteristics Comparison" sections.

Here's the information formatted according to your request, with notes indicating where the requested AI-specific information is not present in this document:

1. Table of Acceptance Criteria and Reported Device Performance

SL.NO	CRITERIA	SPECIFICATION AS PER ASTM D3577-09 STANDARD / Acceptance Criteria	AVERAGE VALUE OF SUBJECT DEVICE / Reported Device Performance
1	Length
	Size 5½	Min 265mm	276 mm
	Size 6	Min 265mm	278mm
	Size 6½	Min 265mm	281mm
	Size 7	Min 265mm	281mm
	Size 7½	Min 265mm	281mm
	Size 8	Min 265mm	283mm
	Size 8½	Min 265mm	283mm
	Size 9	Min 265mm	284mm
2	Width
	Size 5½	70+/-6mm	74mm
	Size 6	76+/-6mm	79mm
	Size 6½	83+/-6mm	87mm
	Size 7	89+/-6mm	93mm
	Size 7½	95+/-6mm	98mm
	Size 8	102+/-6mm	106mm
	Size 8½	108+/-6mm	112mm
	Size 9	114+/-6mm	118mm
3	Finger Thickness (All sizes)	Min 0.10mm	0.18mm
4	Palm Thickness (All sizes)	Min 0.10mm	0.16mm
5	Cuff Thickness (All sizes)	Min 0.10mm	0.12mm
6	Tensile Strength
	Before aging (All sizes)	24Mpa minimum	28.5Mpa
	After aging @ 70°±2C for 166±2 hr (All sizes)	18Mpa minimum	24.2Mpa
7	Ultimate Elongation
	Before aging (All sizes)	750% minimum	934%
	After aging @ 70°±2C for 166±2 hr (All sizes)	560% minimum	758%
8	Stress at 500% before aging (All sizes)	5.5 MPa Max	3 Mpa
9	Pinhole AQL
	Before aging (All sizes)	Max 1.5	1.0
	After aging @ 70°C for 7 days (All sizes)	Max 1.5	1.0
10	Freedom from Holes	Complies with ASTM D3577 and ASTM D5151	Yes (device met acceptance criteria)
11	Powder Content for powdered glove	ASTM D3577 and ASTM D6124 (Max 15 mg/dm²)	10 mg/dm² on average (device met acceptance criteria)
12	Powder Content for powder free glove	ASTM D3577 and ASTM D6124 (Powder content

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