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A powder-free 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.

Device Description

Powder-free Black Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.

AI/ML Overview

The provided text describes the performance testing and acceptance criteria for "Black Nitrile Examination Gloves, Powder Free, Non Sterile." Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Requirement	Standard (Acceptance Criteria)	Reported Device Performance	Meets Criteria?
Physical Dimension	Length $\geq$ 230 mm
Width = 95 + 10 mm
Thickness $\geq$ 0.05 mm (Finger, Palm, Cuff)	Length = 240.9 mm
Width = 97.7 mm
Thickness:

Finger = 0.148 mm
Palm = 0.109 mm
Cuff = 0.092 mm | Yes |
| Physical Properties | Unaged:
TS (Tensile Strength) = 14 MPa
UE (Ultimate Elongation) = 500 %
Aged:
TS = 14 MPa
UE = 400 % | Unaged:
TS = 18.8 MPa
UE = 679.4 %
Aged:
TS = 21.3 MPa
UE = 767.4 % | Yes |
| Freedom from Pinholes | Acc / Rej = 3 / 4 (This likely refers to an AQL (Acceptable Quality Limit) level, implying a maximum number of accepted or rejected units per sample based on the standard) | Not explicitly stated in numerical terms, but the device is implied to have passed based on "Acc / Rej = 3 / 4" under STANDARDS. | Implied Yes |
| Moisture Content | 0.8% | 0.46% | Yes |
| Powder Residue |

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