(22 days)
A patient examination glove is a disposable device intended for medical purposes, that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.
The provided text describes the acceptance criteria and performance data for "Evergreen Non-Sterile Powder Free Latex Examination Gloves." This is a medical device, and the data presented describes its physical characteristics and biocompatibility, not an AI/ML-driven device. As such, several requested sections, particularly those pertaining to AI/ML specific studies (e.g., multi-reader multi-case studies, standalone algorithm performance, AI training/test sets, expert qualifications for AI ground truth), are not applicable to this document.
Below is a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| TEST | Acceptance Criteria (ASTM D3578-95 & FDA) | Reported Device Performance (Evergreen Powder Free Latex Examination Gloves) |
|---|---|---|
| 1. Watertight (1000ml) | G II (AQL=4.0%) | Pass G II (AQL=4.0%) |
| 2. Length (mm) - XS | Min 230 | 240 mm minimum for all sizes |
| 2. Length (mm) - S | Min 230 | 240 mm minimum for all sizes |
| 2. Length (mm) - M | Min 230 | 240 mm minimum for all sizes |
| 2. Length (mm) - L | Min 230 | 240 mm minimum for all sizes |
| 2. Length (mm) - XL | - | 240 mm minimum for all sizes |
| 3. Palm Width (mm) - XS | - | 73 - 78 |
| 3. Palm Width (mm) - S | 80 ± 10 | 83 - 88 |
| 3. Palm Width (mm) - M | 95 ± 10 | 93 - 98 |
| 3. Palm Width (mm) - L | 111 ± 10 | 103 - 107 |
| 3. Palm Width (mm) - XL | - | - |
| 4. Thickness (mm) - Finger (Single Layer) | min 0.08 | 0.10 minimum |
| 4. Thickness (mm) - Palm (Single Layer) | min 0.08 | 0.10 minimum |
| 5. Physical Properties - Before Ageing: Tensile Strength (Mpa) | min 14 | 23.8-25.2 |
| 5. Physical Properties - Before Ageing: Ultimate Elongation (%) | min 700 | 810-910 |
| 5. Physical Properties - After Ageing: Tensile Strength (Mpa) | min 14 | 19.8-20.7 |
| 5. Physical Properties - After Ageing: Ultimate Elongation (%) | min 500 | 750-870 |
| 6. Powder Content | - | below 2 mg/glove |
| 7. Protein Content | - | below 50 microgram/gram |
| 8. Biocompatibility | Pass (Primary Dermal Irritation Test & Guinea Pig Sensitization) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for watertightness, length, etc.). It references "Performance data of gloves based on ASTM D3578-95 and FDA 1000ml watertight test." These standards typically define acceptable sampling plans for quality control, but the specific numbers used in this submission are not provided.
The data provenance is from YTY INDUSTRY (MANJUNG) SDN. BHD. in Malaysia. The studies appear to be prospective, laboratory-based quality control tests conducted on their produced gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This question is not applicable. The "ground truth" for glove performance is established by objective physical and chemical testing methods according to specified ASTM and FDA standards, not by expert interpretation or consensus. No human experts are mentioned as establishing ground truth for these types of tests.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective measurements that require consensus. For physical and chemical tests of gloves, the results are objectively measured and compared against predefined criteria; there is no human adjudication process involved beyond validating the test methodology and results.
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 question is not applicable. The device is a medical glove, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study, human reader improvement with AI, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable. The device is a medical glove; there is no algorithm or AI component involved.
7. The Type of Ground Truth Used:
The ground truth is based on objective measurements and results from standardized physical, chemical, and biocompatibility tests as defined by:
- ASTM D3578-95 (Standard Specification for Latex Examination Gloves)
- FDA's 1000ml watertight test requirements
- FDA's minimum powder residual content requirements
- Biocompatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test) based on established protocols.
8. The Sample Size for the Training Set:
This question is not applicable. There is no AI/ML model for which a training set would be required. The manufacturing process of the gloves would involve quality control and process validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no AI training set.
§ 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.