(65 days)
MICRO-TOUCH* Powder Free Latex Surgical Gloves are intended for single use in a variety of hospital and surgical procedures to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.
MICRO-TOUCH Powder Free Latex Surgical Gloves meet the description of Rubber Surgical Gloves as described in American Society for Testing Materials (ASTM D 3577-91) as Type 1 gloves compounded primarily from rubber latex. They are white in color and are non-powdered. They are packaged sterile in pairs in sizes 5-1/2 through 9.
This document describes a 510(k) submission for "MICRO-TOUCH* POWDER FREE LATEX SURGICAL GLOVES". This is a regulatory submission for a medical device that does not involve artificial intelligence (AI). Therefore, the requested information regarding AI acceptance criteria, performance, and related study details is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's a breakdown based on the provided text, indicating why AI-specific questions are not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets ASTM D-3577-91 standards | Product meets the requirements of ASTM D-3577-91. |
| Meets 21 CFR 800.20 requirements | Product meets the requirements of 21 CFR 800.20. |
| No primary skin irritation in rabbit | No irritation indicated. |
| No delayed contact sensitization in guinea pig | No sensitization indicated. |
| Negative for the presence of starch (USP iodine test) | Final product is negative for the presence of starch. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the non-clinical tests (e.g., how many gloves were tested for ASTM standards, how many rabbits/guinea pigs were used). The data provenance is non-clinical laboratory and animal data, likely conducted by the manufacturer or contracted labs. No country of origin is specified for the data itself, but the manufacturer is based in Arlington, Texas, USA. These tests are inherently prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical glove, not an AI-powered diagnostic or interpretive device that requires expert ground truth establishment for its performance metrics. The "ground truth" here is determined by objective physical and biological tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation or AI-driven systems where there might be disagreement in expert opinions. For physical and biological tests of a glove, the results are typically objectively measured against pre-defined criteria.
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
Not applicable. This is not an AI-assisted device. No human-in-the-loop performance or MRMC studies were conducted as they are irrelevant for a surgical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The device is a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is established by:
- Established standards: ASTM D-3577-91 and 21 CFR 800.20 for physical properties.
- Biocompatibility test results: Observed biological reactions in animals (skin irritation, sensitization) against accepted criteria for "no irritation" or "no sensitization."
- Chemical tests: USP iodine test for starch presence.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a surgical glove.
§ 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).