(152 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 I, 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 Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This document pertains to the regulatory submission for a medical device (examination gloves), and thus, the concepts of "acceptance criteria," "study," "training set," "test set," "ground truth," and "experts" as they relate to advanced AI/ML algorithms or diagnostic devices are not directly applicable in the same way.
The document primarily focuses on demonstrating substantial equivalence of the gloves to a predicate device, as required for Class I medical devices. This involves showing that the device meets established industry standards and biocompatibility requirements.
Here's an interpretation of your request based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00) | Meets requirements (Inspection Level S-2, AOL 2.5) |
| FDA 1000 ml. Water Fill Test | Meets requirements (AOL 2.5, Inspection Level I) |
| Primary Skin Irritation Testing | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) Testing | No sensitization reactions |
| Powder-Free Claims | Contains no more than 2 mg powder per glove |
| Biocompatibility | Meets requirements (as per Section 7 data) |
| Pinhole requirements | Meets FDA requirements (as per Section 7 data) |
| Labeling Claims | Meets requirements (as per Section 7 data) |
| Applicable 21 CFR references | Conforms fully to applicable 21 CFR references |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Testing: The document mentions "samplings of AOL 2.5, Inspection Level I" for the FDA 1000 ml Water Fill Test, and "Inspection Level S-2, AOL 2.5" for Physical and Dimensions Testing. These are Acceptable Quality Level (AQL) standards used in statistical quality control for batch inspection, not a fixed sample size in the traditional sense of a clinical study. The AQL specifies the maximum percentage of defective units considered acceptable in a batch. To determine the exact sample size for a given batch size, one would need to refer to military standard tables (e.g., MIL-STD-105E or ISO 2859-1) for single-sampling plans based on the specified inspection levels and AQLs. The document does not explicitly state the number of gloves sampled.
- Data Provenance: The testing was conducted by Zibo Goldenline Plastic Products Co., Ltd. in Zibo, Shandong, China. The testing would have been prospective, as it was performed on the manufactured gloves to assess their quality against the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept is not applicable. For an examination glove, "ground truth" is established by adherence to predefined physical and chemical specifications and performance standards (like ASTM-D-5250-00 and FDA water fill test). The "experts" are the testing personnel and the certifying bodies who verify compliance with these standards, not medical experts establishing a diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to resolve discrepancies. For physical product testing, results are objective measurements against a standard, not subjective interpretations requiring 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. MRMC studies are relevant for diagnostic or AI-assisted interpretation devices. This document describes a physical medical device (gloves) and does not involve human interpretation or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the examination gloves is defined by:
- Industry Standards: Adherence to ASTM-D-5250-00 for physical properties and dimensions.
- Regulatory Requirements: Meeting FDA's 1000 ml Water Fill Test for barrier integrity and specific biocompatibility requirements (primary skin irritation, skin sensitization).
- Manufacturer Specifications: Meeting internal "powder-free" claims (≤ 2 mg powder per glove).
These are objective, measurable criteria, not subjective expert consensus or diagnostic outcomes.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of examination glove manufacturing and regulatory submission. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth for it.
§ 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.