(121 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.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-00.
The provided text is a 510(k) summary for Zibo Wanci Plastic & Rubber Co., Ltd.'s Synthetic Vinyl Patient Examination Gloves - Powder Free. This document establishes the substantial equivalence of the device to a predicate device, rather than proving its effectiveness through a typical clinical study with acceptance criteria, human readers, or specific outcomes data regarding disease.
The "acceptance criteria" discussed in this document refer to adherence to established industry standards and regulatory requirements for medical gloves, and the "study" is a series of non-clinical tests performed to demonstrate compliance with these standards.
Here's an analysis of the provided information in the requested format:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Requirement | Reported Device Performance | Study Reference |
|---|---|---|---|
| Physical and Dimensions Testing: | ASTM-D-5250-00 | ||
| - ASTM-D-5250-00 | Meet all requirements | All testing meets requirements for Physical and Dimensions Testing. | Section 7 |
| - Inspection Level S-2 | AOL 2.5 | Meets AOL 2.5 | Section 7 |
| Freedom from Holes (FDA Water Fill Test): | FDA 1000 ml. Water Fill Test | ||
| - FDA 1000 ml. Water Fill Test | AOL 2.5 (Inspection Level I) | Meets these requirements with samplings of AOL 2.5, Inspection Level I. | Section 7 |
| Biocompatibility Testing: | |||
| - Primary Skin Irritation | No primary skin irritant reactions | Results showing no primary skin irritant reactions. | Section 7 |
| - Skin Sensitization (allergic contact dermatitis) | No sensitization reactions | Results showing no sensitization reactions. | Section 7 |
| Powder-Free Claim: | No more than 2 mg powder per glove | Conducted to insure that our gloves meet our "powder-free" claims. | Section 7 |
2. Sample size used for the test set and the data provenance
- Sample Size for Physical and Dimensions Testing: The document mentions "Inspection Level S-2, AOL 2.5". This refers to an Acceptance Quality Limit (AQL) sampling plan described in ASTM standards. However, the specific number of gloves sampled for these tests is not explicitly stated.
- Sample Size for FDA 1000 ml. Water Fill Test: The document mentions "samplings of AOL 2.5, Inspection Level I". The specific number of gloves sampled for this test is not explicitly stated.
- Sample Size for Biocompatibility Testing: The specific number of subjects or samples used for primary skin irritation and skin sensitization testing is not explicitly stated.
- Data Provenance: The tests were conducted by the manufacturer, Zibo Wanci Plastic & Rubber Co., Ltd., presumably in China. The data is retrospective for the purpose of this 510(k) submission, meaning the tests were performed prior to the submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For medical gloves, "ground truth" is not established by expert consensus on diagnoses or interpretations. Instead, compliance with objective, measurable performance standards (e.g., tensile strength, dimensions, freedom from holes, biocompatibility) is the "ground truth." These standards are developed by organizations like ASTM and regulatory bodies like the FDA. The testing itself is typically performed by trained technicians in a laboratory setting according to the standard's methodology.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, especially in image-based diagnostic studies. For objective physical and chemical properties of medical gloves, the results are determined by adherence to pre-defined numerical thresholds and test methodologies, not by expert consensus or adjudication. The "adjudication" is met when the test results fall within the specified AQLs (Acceptance Quality Limits) or pass/fail criteria.
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 device is a medical glove, a physical product, not an AI-powered diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As mentioned, this is a physical medical device (glove), not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on objective, measurable criteria defined by recognized consensus standards (e.g., ASTM-D-5250-00) and regulatory requirements (e.g., FDA Water Fill Test, biocompatibility guidelines). These standards specify acceptable ranges for physical properties (dimensions, tensile strength, elongation), maximum permissible defect rates (pinholes), and biological reactions (irritation, sensitization).
8. The sample size for the training set
- Not Applicable. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical medical device, not the development of an AI model.
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.
§ 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.