(221 days)
The Biogel® PI Micro Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The subject device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic polyisoprene material (not made from natural rubber latex).
The provided text describes a 510(k) summary for the Biogel® PI Micro Indicator Underglove (K150146). This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI algorithm or its performance.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to this document as it pertains to a physical medical device (surgical glove) and not an AI/ML-driven device.
However, I can extract the acceptance criteria and reported device performance related to the physical characteristics and biocompatibility of the surgical glove.
1. Table of Acceptance Criteria and Reported Device Performance
| 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 (ASTM D3577) | Meets ASTM D3577 requirements for length, width, and thickness. |
| Physical Properties (ASTM D3577) | Meets ASTM D3577 requirements for tensile strength and elongation at break before and after accelerated aging. |
| Freedom from holes (21 CFR 800.20 and ASTM D3577, tested according to ASTM D5151) | Exceeds 21 CFR 800.20 and ASTM D3577 requirements of AQL 1.5. |
| Powder residual (ASTM D3577 tested according to ASTM D6124) | Meets powder level requirements for "Powder-free" designation per ASTM D3577. |
Details Not Applicable to this Document:
- Sample size used for the test set and the data provenance: Not applicable. This document describes testing for a physical device, not an AI algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the results of standardized physical and biological tests on the glove material.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI algorithms, not a physical surgical glove.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: For physical characteristics and biocompatibility, the ground truth is established by the specified ASTM and ISO standards for measuring these properties (e.g., tensile strength, hole detection via water leak test, irritation response).
- The sample size for the training set: Not applicable. There is no AI algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
This submission is primarily comparing a new physical device (Biogel® PI Micro Indicator Underglove) to a previously cleared predicate device (Biogel® PI Indicator® Underglove) based on established regulatory standards for surgical gloves.
§ 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).