(44 days)
A medical glove 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.
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I Latex Patient Examination Glove 80 LYL, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-95 and FDA Water Leak Test.
The provided text describes the acceptance criteria and the results of tests performed on "Evergreen Non-Sterile Powdered Latex Examination Gloves" to demonstrate their compliance with established standards.
Here's the information extracted and organized:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test / Characteristic | Acceptance Criteria (ASTM D3578-95) | Reported Device Performance (Evergreen Gloves) |
|---|---|---|---|
| Dimensions | Minimum Length (all sizes) | 230 mm minimum | 240 mm minimum |
| Thickness – Finger | 0.08 mm minimum | 0.10 mm minimum | |
| Thickness – Palm | 0.08 mm minimum | 0.10 mm minimum | |
| X Small Width | 70 mm +/- 10 mm | 73 - 78 mm | |
| Small Width | 80 mm +/- 10 mm | 83 - 88 mm | |
| Medium Width | 90 mm +/- 10 mm | 93 - 98 mm | |
| Large Width | 100 mm +/- 10 mm | 103 - 107 mm | |
| Physical Properties | Tensile Strength (Before Aging) | 14.0 Mpa | 26.7 Mpa |
| Ultimate Elongation (Before Aging) | 700% | 840% | |
| Tensile Strength (After Aging) | 14.0 Mpa | 21.8 Mpa | |
| Ultimate Elongation (After Aging) | 500% | 820% | |
| Integrity | Water Tight Test (FDA Water Leak Test Method) | AQL 4.0% General Inspection II multiple sampling plan (specific pass/fail based on sample size and defects) | Passed (e.g., 1 unit leak in 80 for Large/Medium, 0 for Small) |
| Biocompatibility | Primary Dermal Irritation Test | (Implicitly passed for acceptance) | Passed |
| Skin Sensitization Study | (Implicitly passed for acceptance) | Passed | |
| Protein Content | Water Soluble Protein Test (ASTM D5712) | No Label Claim on Protein Level | 209 ug/g (against OVBM) (for one batch) |
2. Sample Sizes Used for the Test Set and Data Provenance:
-
Water Tight Test:
- Sample Size: 80 pieces of gloves per batch were tested.
- Data Provenance: The testing was performed by YTY Industry (Manjung) Sdn Bhd (Malaysia). It appears to be retrospective testing of produced batches.
-
Dimensional, Tensile Strength, and Elongation Tests:
- The document does not explicitly state the sample size for these tests. It reports specific values for "YTY's Gloves" which implies samples were taken and tested, but the number of units is not provided.
- Data Provenance: Presumably from internal testing conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia). Also appears retrospective.
-
Biocompatibility Tests:
- The document does not state the sample size.
- Data Provenance: Not explicitly stated, but typically done by third-party labs. The document only states "The gloves pass the Biocompatibility Tests."
-
Water Soluble Protein Test:
- Sample Size: Not explicitly stated, but results are given for one "Batch No. Production Date."
- Data Provenance: Presumably from internal testing conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This document describes performance testing against established industry standards (ASTM D3578-95, FDA Water Leak Test, ASTM D5712, etc.) for physical and chemical properties of gloves. The "ground truth" is defined by these objective engineering and regulatory standards, not by expert consensus on subjective observations.
4. Adjudication Method for the Test Set:
- None. The tests described are objective measurements (dimensions, strength, elongation) or standardized pass/fail criteria (water leak, biocompatibility). There is no "adjudication" in the sense of multiple human reviewers resolving discrepancies in a subjective assessment. The water leak test uses an AQL (Acceptable Quality Level) sampling plan, which is a statistical method for determining acceptance based on defects, not expert adjudication.
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 document is for the premarket approval of a medical device (latex examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI comparison is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used:
- The ground truth is based on established engineering and material science standards and regulatory requirements. Specifically:
- ASTM D3578-95 Standard (for dimensions, tensile strength, ultimate elongation).
- FDA Water Leak Test requirements (for integrity/holes).
- ASTM D5151-90 Test method for Detection of Holes in Medical Gloves.
- Biocompatibility test standards (Primary Dermal Irritation Test and Skin Sensitization Study, though specific standard numbers are not given here).
- ASTM D5712 standards (for Water Soluble Protein Test).
8. The sample size for the training set:
- Not applicable. Since this is not an AI/machine learning model, there is no "training set." The glove manufacturing process is controlled to meet these pre-defined specifications through quality control and process validation.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question is not relevant. The "ground truth" for the product's performance is the adherence to the published ASTM and FDA standards.
§ 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.