(226 days)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
The proposed device, Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound fromcontamination. The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015). The classification is: Type I - gloves compounded primarily from natural rubber latex". The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
This document is a 510(k) Premarket Notification for Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Criteria | Specification as per ASTM D3577-09 Standard | Average Value of Subject Device (Reported Performance) | Device Complied? |
|---|---|---|---|
| Length | |||
| Size 5½ | Min 265mm | 282mm | Yes |
| Size 6 | Min 265mm | 282mm | Yes |
| Size 6½ | Min 265mm | 282mm | Yes |
| Size 7 | Min 265mm | 282mm | Yes |
| Size 7½ | Min 265mm | 282mm | Yes |
| Size 8 | Min 265mm | 282mm | Yes |
| Size 8½ | Min 265mm | 282mm | Yes |
| Size 9 | Min 265mm | 282mm | Yes |
| Width | |||
| Size 5½ | 70 ± 6mm | 71mm | Yes |
| Size 6 | 76 ± 6mm | 78mm | Yes |
| Size 6½ | 83 ± 6mm | 82mm | Yes |
| Size 7 | 89 ± 6mm | 90mm | Yes |
| Size 7½ | 95 ± 6mm | 95mm | Yes |
| Size 8 | 102 ± 6mm | 100mm | Yes |
| Size 8½ | 108 ± 6mm | 106mm | Yes |
| Size 9 | 114 ± 6mm | 112mm | Yes |
| Finger Thickness (All sizes) | Min 0.10mm | 0.20mm | Yes |
| Palm Thickness (All sizes) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (All sizes) | Min 0.10mm | 0.13mm | Yes |
| Tensile Strength Before aging (All sizes) | 24Mpa minimum | 26.5Mpa | Yes |
| Tensile Strength After aging (All sizes) | 18Mpa minimum | 21.0Mpa | Yes |
| Ultimate Elongation Before aging (All sizes) | 750% minimum | 860% | Yes |
| Ultimate Elongation After aging (All sizes) | 560% minimum | 725% | Yes |
| Stress at 500% before aging (All sizes) | 5.5 MPa Max | 2.6 Mpa | Yes |
| Pinhole AQL Before aging (All sizes) | Max 1.5 | 1.0 | Yes |
| Pinhole AQL After aging (All sizes) | Max 1.5 | 1.0 | Yes |
| Powder Residue (Powder-Free Glove) |
§ 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).