(185 days)
A Pre-Powdered Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Patient Examination Gloves are a Class I device 21 CFR 880. These gloves are pre-powdered with a PMA approved Corn Starch Powder. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.
This document describes the acceptance criteria and the study conducted for the Safe Shield Pre-Powdered Latex Examination Gloves (K013980).
The device in question, a pre-powdered latex examination glove, is a Class I medical device, which typically does not require extensive clinical studies to demonstrate safety and effectiveness. Instead, substantial equivalence to a predicate device is shown through non-clinical performance testing against recognized standards.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The study for this device primarily involved non-clinical performance testing against established standards. The acceptance criteria are derived from ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves, as well as specific MIL-STD-105E AQLs. The document presents the physical specifications and properties as "minimums," implying these are the acceptance criteria, and the device is implied to meet or exceed these values.
| Criterion | Acceptance Criteria (Minimum) | Reported Device Performance (Implied Met) |
|---|---|---|
| Physical Specifications: | ||
| Length | 230 mm | Met (as implied by substantial equivalence) |
| Thickness | 0.08 mm | Met (as implied by substantial equivalence) |
| Width (Small) | 80 ± 10 mm | Met (as implied by substantial equivalence) |
| Width (Medium) | 95 ± 10 mm | Met (as implied by substantial equivalence) |
| Width (Large) | 110 ± 10 mm | Met (as implied by substantial equivalence) |
| Physical Properties (Before Aging): | ||
| Tensile Strength | 21 Mpa | Met (as implied by substantial equivalence) |
| Ultimate Elongation | 700% | Met (as implied by substantial equivalence) |
| Physical Properties (After Aging): | ||
| Tensile Strength | 16 Mpa | Met (as implied by substantial equivalence) |
| Ultimate Elongation | 500% | Met (as implied by substantial equivalence) |
| Sampling and AQLs: | ||
| Water Tight Test (AQL) | 2.5 (G-II sampling) | Met (as implied by conformance with FDA requirement/MIL-STD-105E) |
| Dimensions (AQL) | 4.0 (S-2 sampling) | Met (as implied by conformance with ASTM/FDA requirements) |
| Physical Properties (AQL) | 4.0 (S-2 sampling) | Met (as implied by conformance with ASTM/FDA requirements) |
| Pin Hole Testing (AQL) | 4.0 (G-II sampling, normal inspection) | Met (as implied by conformance with FDA 1000ml water fill test and MIL-STD-105E) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document refers to sampling plans based on MIL-STD-105E, specifically "General Inspection Level G II, normal inspection and acceptable quality level of 4.0" for Pin Hole Testing, and "G-II" for Water Tight Test (AQL 2.5), and "S-2" for Dimensions and Physical Properties (AQL 4.0). However, the specific number of units tested (sample size in concrete numbers for each test) is not explicitly stated. MIL-STD-105E defines sample sizes based on lot size and inspection level, but these actual numbers are not provided in the summary.
- Data Provenance: The data is generated from tests performed by the manufacturer, Safe Shield Co. Ltd. The country of origin for the data generation would be Thailand, where the company is located. The testing is prospective in the sense that it's performed on newly manufactured devices to demonstrate compliance for regulatory submission.
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 Class I glove, and its performance is assessed through objective physical and chemical testing against established standards (ASTM, FDA regulations, MIL-STD). There is no "ground truth" established by human experts in the way it would be for an AI diagnostic device. The performance is determined by measurable physical properties.
4. Adjudication method for the test set
Not Applicable. As mentioned above, there's no human adjudication involved in determining the test results for physical properties of gloves. The tests are objective and follow standard protocols (e.g., water fill test, tensile strength measurement).
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 a physical device (examination glove), not an AI software. Therefore, an MRMC study or any assessment of AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective, measurable physical properties defined by:
- ASTM 3578-00 standard for latex examination gloves,
- Food and Drug Administration (FDA) requirements for Patient Examination Gloves (including the 1000 ml Water fill test described in 21 CFR 800.20), and
- MIL-STD-105E for sampling and acceptable quality levels (AQLs).
These are established industry and regulatory standards for glove quality.
8. The sample size for the training set
Not Applicable. "Training set" is a concept typically used for AI/machine learning models. This device is a physical product and does not involve any machine learning for its function or performance assessment. Its manufacturing process would be subject to quality control, but not a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
§ 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.