(104 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, 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 D35 77 -09. 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 +and place in a sterility maintenance package to ensure a shelf life of 3 years.
This document is a 510(k) premarket notification for a medical device: "Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein)".
The acceptance criteria and study proving the device meets those criteria are detailed through non-clinical testing against established ASTM and ISO standards for surgical gloves.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| Criteria | Specification (Acceptance Criteria per ASTM D3577-09 Standard) | Reported Device Performance (Average Value of Subject Device) | Device Complied? |
|---|---|---|---|
| Length | Min 265mm | ||
| Size 5'2 | Min 265mm | 281 mm | Yes |
| Size 6 | Min 265mm | 281mm | Yes |
| Size 6'2 | Min 265mm | 282mm | Yes |
| Size 7 | Min 265mm | 282mm | Yes |
| Size 7'2 | Min 265mm | 282mm | Yes |
| Size 8 | Min 265mm | 283mm | Yes |
| Size 8'2 | Min 265mm | 283mm | Yes |
| Size 9 | Min 265mm | 283mm | Yes |
| Width | |||
| Size 5'2 | 70+/-6mm | 74mm | Yes |
| Size 6 | 76+/-6mm | 78mm | Yes |
| Size 6'2 | 83+/-6mm | 84mm | Yes |
| Size 7 | 89+/-6mm | 91mm | Yes |
| Size 7'2 | 95+/-6mm | 97mm | Yes |
| Size 8 | 102+/-6mm | 103mm | Yes |
| Size 8'2 | 108+/-6mm | 109mm | Yes |
| Size 9 | 114+/-6mm | 115mm | Yes |
| Finger Thickness (All) | Min 0.10mm | 0.18mm | Yes |
| Palm Thickness (All) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (All) | Min 0.10mm | 0.13mm | Yes |
| Tensile Strength | |||
| Before aging (All) | 24Mpa minimum | 28.0Mpa | Yes |
| After aging (All) | 18Mpa minimum | 24.0Mpa | Yes |
| Ultimate Elongation | |||
| Before aging (All) | 750% minimum | 920% | Yes |
| After aging (All) | 560% minimum | 750% | Yes |
| Stress at 500% (All) | 5.5 MPa Max | 3 Mpa | Yes |
| Pinhole AQL | |||
| Before aging (All) | Max 1.5 | 1.0 | Yes |
| After aging (All) | Max 1.5 | 1.0 | Yes |
| Powder Content |
§ 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).