(169 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the requirements of ASTM D 3577-06, Type 2.
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the current specifications of ASTM D 3577-06, Type 2.
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
Characteristics: Dimensions, Physical Properties, Freedom from Holes, Powder Free
Standard: Meets ASTM D 3577, Meets ASTM D 3577, Type 2, Meets ASTM D 3577, Meets ASTM D 5151, Meets ASTM D 6124
Powder content = 2 mg per glove
This document describes the acceptance criteria and the study that proves the device meets those criteria for the Ansell Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves.
1. Table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from Holes | Meets ASTM D 3577 and ASTM D 5151 | Meets ASTM D 3577 and ASTM D 5151 |
| Powder Free | Meets ASTM D 6124 | Powder content = ≤ 2 mg per glove (Meeting ASTM D 6124) |
| FHSA Skin Irritation Study | Passes | Passes |
| ISO Maximization Sensitization Study | Passes | Passes |
| Cytotoxicity Study using the End-Point Titration Method | Non-Toxic | Non-Toxic at 24 hours |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (e.g., freedom from holes, physical properties, biocompatibility). However, it indicates that the tests conform to established ASTM and ISO standards, which typically include defined sampling plans. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory testing conducted by the manufacturer or a certified lab to demonstrate compliance with the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The ground truth for this device is established through adherence to physical and performance standards (ASTM, ISO, FDA hole requirements) rather than expert consensus on interpretive data (like imaging studies).
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., medical image analysis) to resolve discrepancies among experts. For this device, objective measurements against established standards determine compliance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not applicable and not done. This device is a surgical glove, and its performance is evaluated based on physical properties, freedom from defects, and biocompatibility, not on human interpretive tasks or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone (algorithm-only) performance evaluation was not applicable and not done. This device is a physical product (surgical glove), not an algorithm or AI-driven system.
7. The type of ground truth used
The ground truth used for this device is based on established standard specifications and laboratory testing outcomes. This includes:
- ASTM Standards: Defined dimensional, physical property, and hole specifications provided by ASTM D 3577 and ASTM D 5151.
- ISO Standards: Biocompatibility testing protocols from ISO.
- FDA Hole Requirements: Specific defect rate criteria mandated by the FDA.
- Industry Standards: Powder content standards as specified by ASTM D 6124.
8. The sample size for the training set
This information is not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
§ 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).