(71 days)
The Biogel® PI Micro Surgical Glove is a disposable device made of Poly-Isoprene material that is intended to be worn on the hands, usually in surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The subiect device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic Poly-Isoprene material (not made from natural rubber latex). The gloves are manufactured using hand-specific molds (right and left hand). Each glove contains a beaded cuff to help reduce cuff roll-down during use.
The document describes the Biogel® PI Micro Surgical Glove, a disposable, powder-free surgical glove made from synthetic Poly-Isoprene material. This device is a modification of the previously cleared Biogel® PI Surgical Glove (K050184), with changes in material thickness and the removal of a donning coating.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10 | Under the conditions of the study, not an irritant. |
| ISO Closed Patch Sensitization | ISO 10993-10 | Under the conditions of the study, not a sensitizer. |
| Physical Characteristics | ||
| Dimensions: Length | ASTM D3577 (min. 245 mm for size 5½, 265 mm for size 6-9) | Length: 284 - 310 mm, meet the ASTM minimum requirements. |
| Dimensions: Width | ASTM D3577 (70 - 114 ± 6 mm) | Width: 71 - 116 mm, meet the ASTM requirement. |
| Dimensions: Thickness | ASTM D3577 (min. 0.10 mm) | Thickness: ≥ 0.30 mm, Exceeds the ASTM minimum requirement. |
| Physical Properties: Before ageing | ASTM D3577 | Results meet requirements for rubber surgical gloves. |
| - Tensile strength | 17 MPa min | 28 - 29 MPa |
| - Stress at 500% elongation | 7.0 MPa max. AQL 4.0 | 1.8 - 1.9 MPa |
| - Ultimate elongation | 650 % min | 1100 - 1120 % |
| Physical Properties: After accelerated ageing | ASTM D3577 | Results meet requirements for rubber surgical gloves. |
| - Tensile strength | 12 MPa min | 22 - 24 MPa |
| - Ultimate elongation | 490 % min | 1100 - 1140 % |
| Freedom from holes | 21 CFR 800.20 and ASTM D3577 (AQL 1.5) | Passed AQL 0.65, exceeds 21 CFR 800.20 and ASTM D3577 requirements. |
| Powder residual | ASTM D3577 (≤ 2.0 mg/glove) | Glove meets powder level requirements for "Powder-free" designation (results generated values below 2 mg of residual powder per glove). |
2. Sample size used for the test set and the data provenance
The document specifies standards and tests (e.g., ISO 10993-10, ASTM D3577, ASTM D5151, ASTM D6124) were used to demonstrate performance. However, the specific sample sizes used for each test are not explicitly stated within this document. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes performance testing based on engineering and material science standards (e.g., biocompatibility testing, physical properties, freedom from holes, powder residual), not on subjective expert assessment of an AI's output.
4. Adjudication method for the test set
This section is not applicable for the same reasons as #3. The performance is objectively measured against established standards.
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
This section is not applicable. This document describes a medical device (surgical glove) that functions as a physical barrier. It is not an AI-powered diagnostic or assistive tool, therefore, MRMC studies involving human readers or AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical device, not an algorithm. The performance tests evaluate the glove itself.
7. The type of ground truth used
The ground truth for the performance evaluations are established by widely accepted international and national standards for medical devices and surgical gloves. Specifically:
- Biocompatibility: ISO 10993-10
- Dimensions & Physical Properties: ASTM D3577
- Freedom from holes: 21 CFR 800.20 and ASTM D3577, tested according to ASTM D5151
- Powder residual: ASTM D3577, tested using ASTM standard D6124
These standards define the acceptable range or threshold for each characteristic.
8. The sample size for the training set
This section is not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
§ 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).