(196 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, JR Medic Latex Surgeon's Gloves Sterile 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 D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves. 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 using Gamma irradiation 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 document describes the acceptance criteria and a study proving that JR MEDIC Latex Surgeon's Gloves Sterile Powder Free meet these criteria.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Specification per ASTM D3577-09) | Reported Device Performance (Average Value) | Compliance |
|---|---|---|---|
| Length (for all sizes) | Min 265mm | 305mm - 306mm | Yes |
| Width | |||
| Size 6 | 76+/-6mm | 78mm | Yes |
| Size 6 1/2 | 83+/-6mm | 85mm | Yes |
| Size 7 | 89+/-6mm | 88mm | Yes |
| Size 7 1/2 | 95+/-6mm | 97mm | Yes |
| Size 8 | 102+/-6mm | 103mm | Yes |
| Size 8 1/2 | 108+/-6mm | 110mm | Yes |
| Size 9 | 114+/-6mm | 116mm | Yes |
| Thickness (for all sizes) | |||
| Finger Thickness | Min 0.10mm | 0.21mm | Yes |
| Palm Thickness | Min 0.10mm | 0.18mm | Yes |
| Cuff Thickness | Min 0.10mm | 0.11mm | Yes |
| Tensile Strength (Before aging) | 24Mpa minimum | 26.0Mpa | Yes |
| Tensile Strength (After aging Pinhole AQL) | 18Mpa minimum | 22.0Mpa | Yes |
| Ultimate Elongation (Before aging) | 750% minimum | 860% | Yes |
| Ultimate Elongation (After aging Pinhole AQL) | 560% minimum | 725% | Yes |
| Stress at 500% (before aging) | 5.5 MPa Max | 2.7 Mpa | Yes |
| Pinhole AQL (Before aging) | Max 1.5 | 1.0 | Yes |
| Pinhole AQL (After aging) | Max 1.5 | 1.0 | Yes |
| Powder content | Pyrogen Test. |
- ISO 11137-1-2006/ (R) 2010 - validation of sterilization process.
- ISO 11137-2:2013, sterilization of health care products - radiation - part 2: establishing the sterilization dose.
8. The sample size for the training set
This is not applicable as this is a non-clinical bench test for a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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).