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A non-powdered 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.

A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

The provided text describes the acceptance criteria and the results of non-clinical performance testing for a medical device, specifically Disposable Powder Free Vinyl Exam Gloves.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

• Palm - 0.08 mm min.
• Finger - 0.08 mm min.
  Palm Width:
• Small 85 ± 5 mm
• Medium 95 ± 5 mm
• Large 105 ± 5 mm
• X Large 115 ± 5 mm | Pass |
  | Freedom from holes (Water leak) | G-I/AQL 2.5 | Pass |
  | Tensile strength | Before Aging: 11 MPa, min.
  After Aging: 11 MPa, min. | Pass |
  | Elongation | Before Aging: 300% min.
  After Aging: 300% min. | Pass |
  | Powder Residual |

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