(55 days)
A patient examination glove is a disposable device intended for medical purposes that is worr on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A 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.
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250. Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient Examination Gloves:
The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics in the typical sense of a clinical trial. However, we can extract the relevant information regarding the standards and tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ASTM D5250-92 manufacturing requirements (Physical and Dimensions Testing) | Meets all requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. |
| FDA 1000 ml. Water Fill Test (for pinholes) | Meets requirements with samplings of AQL 2.5, Inspection Level S-4. |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions. |
| USP Iodine Test for Starch | Meets "powder-free" claim (conducted at finished inspection). |
| "Powder residue by weight" testing | Adheres to USP Iodine Test methodology. |
| Particulate testing | Contracting with a laboratory for added assurance (implies intent to meet standards, but specific results not reported here). |
| Light Transmission Test | Final release testing consists of this (implies meeting internal criteria, but specific criteria/results not detailed). |
| Applicable 21 CFR references | Conforms fully. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size:
- For ASTM D5250-92 Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific number of units tested is not provided, but these are standard sampling plans.)
- For FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. (Specific number of units tested is not provided.)
- For Primary Skin Irritation and Skin Sensitization: Not specified, but generally involves a set number of human subjects or animal models according to standard protocols.
- For USP Iodine Test/Powder Residue/Light Transmission: Conducted at finished inspection and final release; specific sample sizes for these internal quality control tests are not provided in this summary.
- Data Provenance: The device is manufactured by SHANGHAI HUAMAO GLOVES CO., LTD. in Shanghai, China. The testing was presumably conducted by or for the manufacturer. The data is retrospective in the sense that it summarizes tests already performed on manufactured batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe a scenario where experts established ground truth in the context of a typical diagnostic or AI study. The "ground truth" here is defined by meeting established regulatory standards (ASTM, FDA water fill test, USP, biocompatibility tests). These standards have predetermined pass/fail criteria, often implemented by trained technicians or quality control personnel in a laboratory setting. There isn't a "consensus of experts" forming a ground truth here.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective measurements against defined standards (e.g., AQL levels for defects, specific chemical tests, physical property limits). There is no "adjudication" between multiple expert opinions, as the assessment is based on direct measurement against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a Class I medical device (patient examination gloves) and the submission focuses on demonstrating substantial equivalence through performance against established material and safety standards, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-driven device. The "performance" is the physical and chemical properties of the gloves themselves.
7. The Type of Ground Truth Used
The ground truth is based on regulatory standards and established test methodologies (e.g., ASTM D5250-92 for physical properties, FDA 1000 ml. Water Fill Test for barrier integrity, USP Iodine Test for powder content, and biocompatibility standards for skin irritation/sensitization). These are objective, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set" in that context. The "training" in manufacturing refers to adherence to good manufacturing practices and quality control processes to ensure consistency.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. The manufacturing process itself (which could be loosely considered "training" if one were to stretch the analogy) is validated by adhering to established quality management systems (like GMP - Good Manufacturing Practice, mentioned in the FDA letter). The ground truth for successful manufacturing is producing gloves that consistently meet the specifications outlined in the standards (ASTM, FDA, USP, etc.).
§ 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.