(228 days)
A latex surgeon's gloves 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 Powdered and 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 D3577-09. The rubber surgical gloves classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and the come in different sizes ( 5½, 6, 6½, 7, 7½, 8, 8½, 9 ). All gloves share the same color, creamy white and all have beaded cuff and textured at the finger tips and palm. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10th and place in a sterility maintenance package to ensure a shelf life of 3 years.
This appears to be a 510(k) summary for a medical device (latex surgeon's gloves), not a study specifically designed to assess an AI/ML device or its performance against acceptance criteria in the way typically expected for such technologies. Therefore, many of the requested elements (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not detailed in this document.
However, I can extract the acceptance criteria and demonstrated performance for the physical and biological characteristics of the surgeon's gloves, as described in the "Product Comparison in Compliance with ASTM D 3577-09 Standard" and "Technological Characteristics Comparison" sections.
Here's the information formatted according to your request, with notes indicating where the requested AI-specific information is not present in this document:
1. Table of Acceptance Criteria and Reported Device Performance
| SL.NO | CRITERIA | SPECIFICATION AS PER ASTM D3577-09 STANDARD / Acceptance Criteria | AVERAGE VALUE OF SUBJECT DEVICE / Reported Device Performance |
|---|---|---|---|
| 1 | Length | ||
| Size 5½ | Min 265mm | 276 mm | |
| Size 6 | Min 265mm | 278mm | |
| Size 6½ | Min 265mm | 281mm | |
| Size 7 | Min 265mm | 281mm | |
| Size 7½ | Min 265mm | 281mm | |
| Size 8 | Min 265mm | 283mm | |
| Size 8½ | Min 265mm | 283mm | |
| Size 9 | Min 265mm | 284mm | |
| 2 | Width | ||
| Size 5½ | 70+/-6mm | 74mm | |
| Size 6 | 76+/-6mm | 79mm | |
| Size 6½ | 83+/-6mm | 87mm | |
| Size 7 | 89+/-6mm | 93mm | |
| Size 7½ | 95+/-6mm | 98mm | |
| Size 8 | 102+/-6mm | 106mm | |
| Size 8½ | 108+/-6mm | 112mm | |
| Size 9 | 114+/-6mm | 118mm | |
| 3 | Finger Thickness (All sizes) | Min 0.10mm | 0.18mm |
| 4 | Palm Thickness (All sizes) | Min 0.10mm | 0.16mm |
| 5 | Cuff Thickness (All sizes) | Min 0.10mm | 0.12mm |
| 6 | Tensile Strength | ||
| Before aging (All sizes) | 24Mpa minimum | 28.5Mpa | |
| After aging @ 70°±2C for 166±2 hr (All sizes) | 18Mpa minimum | 24.2Mpa | |
| 7 | Ultimate Elongation | ||
| Before aging (All sizes) | 750% minimum | 934% | |
| After aging @ 70°±2C for 166±2 hr (All sizes) | 560% minimum | 758% | |
| 8 | Stress at 500% before aging (All sizes) | 5.5 MPa Max | 3 Mpa |
| 9 | Pinhole AQL | ||
| Before aging (All sizes) | Max 1.5 | 1.0 | |
| After aging @ 70°C for 7 days (All sizes) | Max 1.5 | 1.0 | |
| 10 | Freedom from Holes | Complies with ASTM D3577 and ASTM D5151 | Yes (device met acceptance criteria) |
| 11 | Powder Content for powdered glove | ASTM D3577 and ASTM D6124 (Max 15 mg/dm²) | 10 mg/dm² on average (device met acceptance criteria) |
| 12 | Powder Content for powder free glove | ASTM D3577 and ASTM D6124 (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).