(88 days)
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is a disposable sterile powder-free medical device made of polyisoprene that is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove contains radiation-attenuating particles to reduce the exposure from harmful ionizing scattered or secondary radiation on the operator's hand during fluoroscopic procedures. The glove is proposed in two (2) options. The Model 2 are made with exactly the same material and composition and differ only by their thicknesses and therefore their attenuation properties.
The provided text describes the acceptance criteria and results of non-clinical performance testing for a medical device, specifically Polyisoprene Powder Free Black Colour Radiation Attenuating Surgical Gloves. It does not describe a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested fields related to AI performance, human reader studies, and training data are not applicable based on the provided document.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5151 | Freedom from holes | AQL 1.5 | PASS (AQL=0.65) |
| ASTM D3577 | Physical Dimensions - Length (Size 6-9) | ≥265mm (Predicate) / ≥285mm (Manufacturer) | PASS (All sizes ≥285mm, range: 298-301mm) |
| ASTM D3577 | Physical Dimensions - Width (various sizes) | Size 6.0: 76 ± 6mm | |
| Size 6.5: 83 ± 6mm | |||
| Size 7: 89 ± 6mm | |||
| Size 7.5: 95 ± 6mm | |||
| Size 8: 102 ± 6mm | |||
| Size 8.5: 108 ± 6mm | |||
| Size 9: 114 ± 6mm | PASS (83-84mm (size 6.5) | ||
| 90-91mm (size 7) | |||
| 96-97mm (size 7.5) | |||
| 106-107mm (size 8) | |||
| 110-113mm (size 8.5) | |||
| 112-115mm (size 9)) | |||
| ASTM D3577 | Physical Dimensions - Thickness | Min. 0.1mm | PASS (Model 1: Finger: 0.27-0.29mm, Palm: 0.24-0.25mm, Cuff: 0.23-0.24mm; Model 2: Finger: 0.33-0.39mm, Palm: 0.33-0.35mm, Cuff: 0.31-0.33mm) |
| ASTM D3577 | Physical Properties - Tensile Strength (Before accelerated aging) | 17 MPa min | PASS (18.7-19.6MPa) |
| ASTM D3577 | Physical Properties - Tensile Strength (After accelerated aging) | 12 MPa min | PASS (18.2-18.5MPa) |
| ASTM D3577 | Physical Properties - Strength at 500% | 7.0 MPa max | PASS (4.1-4.9MPa) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (Before aging) | 650 % min | PASS (700-720%) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (After aging) | 490 % min | PASS (620-645%) |
| ASTM D6124 | Residual powder |
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).