(111 days)
Sterile Latex Surgical Gloves Powder Free 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, Sterile Latex Surgical 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 from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color is added). The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
The provided text describes the acceptance criteria and study results for "Sterile Latex Surgical Gloves Powder Free." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Specification as per ASTM D3577-2019) | Reported Device Performance (Average value of subject device) | Complied with Standard? |
|---|---|---|---|
| Dimensions | |||
| Length (all sizes) | Min 265mm | 383mm (Size 6), 385mm (Size 6.5), 388mm (Size 7), 390mm (Size 7.5), 392mm (Size 8), 394mm (Size 8.5), 396mm (Size 9) | Yes |
| Width (Size 6) | 76+/-6mm | 74mm | Yes |
| Width (Size 6.5) | 83+/-6mm | 86mm | Yes |
| Width (Size 7) | 89+/-6mm | 92mm | Yes |
| Width (Size 7.5) | 95+/-6mm | 98mm | Yes |
| Width (Size 8) | 102+/-6mm | 105mm | Yes |
| Width (Size 8.5) | 108+/-6mm | 110mm | Yes |
| Width (Size 9) | 114+/-6mm | 116mm | Yes |
| Finger Thickness (all sizes) | Min 0.10mm | 0.21mm | Yes |
| Palm Thickness (all sizes) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (all sizes) | Min 0.10mm | 0.12mm | Yes |
| Tensile Strength | |||
| Before aging (all sizes) | 24Mpa minimum | 28.55Mpa | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 18Mpa minimum | 23.48Mpa | Yes |
| Ultimate Elongation | |||
| Before aging (all sizes) | 750% minimum | 870% | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 560% minimum | 731% | Yes |
| Stress at 500% | |||
| Before aging (all sizes) | 5.5 MPa Max | 5.1 Mpa | Yes |
| Pinhole AQL | |||
| Before aging (all sizes) | Max 1.5 | 1.0 | Yes |
| After aging @ 70°C for 7 days (all sizes) | Max 1.5 | 1.0 | Yes |
| Powder Residue |
§ 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).