(58 days)
The Powder Free 911 Latex Examination gloves is disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves (colored) BLUE
This document is a 510(k) clearance letter from the FDA for examination gloves. It is not a study report for an AI/ML device, so much of the requested information regarding AI device performance metrics, study design, and ground truth establishment is not applicable or available in this document.
However, I can extract the relevant information regarding the device and its intended use, and discuss how regulatory acceptance might be framed for a simple medical device like an examination glove, aligning with the spirit of the request as much as possible for a non-AI product.
Device: Powder Free 911 Latex Examination Gloves (Blue)
Regulatory Class: Class I
Product Code: LYY
Indications For Use: The Powder Free 911 Latex Examination gloves is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Given that this is a 510(k) submission for examination gloves, the "acceptance criteria" and "device performance" are typically related to physical properties and biocompatibility, demonstrating substantial equivalence to a predicate device. The "study" would refer to the testing performed to demonstrate these properties.
1. A table of acceptance criteria and the reported device performance
For examination gloves, the acceptance criteria are generally based on industry standards (e.g., ASTM, ISO) and FDA guidance for physical properties and barrier integrity. Since the provided document is a 510(k) summary, specific numerical performance results are not detailed, but the general categories would be:
| Acceptance Criteria Category | Typical Standard / Metric | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|---|
| Physical Properties | Tensile Strength (before & after aging) | Meets or exceeds minimum requirements per ASTM D3578 |
| Elongation (before & after aging) | Meets or exceeds minimum requirements per ASTM D3578 | |
| Puncture Resistance | Meets or exceeds minimum requirements (e.g., comparable to predicate) | |
| Barrier Integrity | Freedom from Holes (AQL) | Meets or exceeds specified Acceptable Quality Level (e.g., 2.5%, 4.0% AQL) via water leak test (ASTM D5151) |
| Biocompatibility | Dermal Sensitization | Passes ISO 10993-10 (no significant sensitization) |
| Primary Skin Irritation | Passes ISO 10993-10 (no significant irritation) | |
| Cytotoxicity | Passes ISO 10993-5 (non-cytotoxic) | |
| Powder Content | For Powder-Free Gloves | Meets or exceeds specified maximum powder content (e.g., ASTM D6124) |
| Dimensions | Length, Palm Width, Finger Thickness | Within specified range per ASTM D3578 |
| Color Additive Safety | For Colored Gloves | Color additive shown to be safe for its intended use |
Note: The actual 510(k) submission document would contain the detailed test reports demonstrating equivalence. The FDA clearance letter implies that these criteria were met to demonstrate substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For examination gloves, the "test set" samples would be batches of gloves produced by the manufacturer.
- Sample Size: Typically, sample sizes for physical property and barrier integrity testing are determined by statistical sampling plans (e.g., ISO 2859-1 for AQL, or specific ASTM standards for destructive testing). These can range from a few gloves per batch for certain destructive tests to hundreds for AQL-based integrity tests.
- Data Provenance: The manufacturing location is Malaysia (BioPro (M) Sdn. Bhd.). The testing would typically be performed at the manufacturer's facility or at an accredited contract laboratory, likely in Malaysia or a country adhering to international standards. This data would be prospective in the sense that the manufacturer tested batches of their new device to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to examination gloves. Ground truth, in the context of AI/ML, refers to a definitive correct answer for a diagnostic or classification task. For physical devices like gloves, "ground truth" is established by direct measurement and standardized testing protocols.
- "Experts": The "experts" would be qualified laboratory technicians and engineers who perform the tests according to established ASTM, ISO, and FDA recognized standards. Their qualifications would include training in laboratory procedures, instrumentation, and quality control. There isn't a "number of experts" in the sense of clinical consensus, but rather adherence to validated methods by qualified personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for AI/ML validation, where there might be disagreements in human expert interpretations that need resolution. For physical characteristic testing of gloves, the results are objective measurements or pass/fail criteria based on defined thresholds. Any discrepancies would be resolved by re-testing or investigation into methodology, not expert consensus.
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. MRMC studies are designed for evaluating diagnostic tools where human interpretation is involved, often comparing human performance with and without AI assistance. Examination gloves are a barrier device, not a diagnostic tool, and do not involve "human readers" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For examination gloves, the "ground truth" is based on:
- Standardized Measurement & Testing: Objective measurements of physical properties (e.g., tensile strength, elongation, dimensions), and direct tests for barrier integrity (e.g., water leak test) and biocompatibility (e.g., in vitro or in vivo biocompatibility assays).
- Predicate Device Performance: Comparison to the performance characteristics of an existing, legally marketed predicate device to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.