(71 days)
A patient examination glove is disposable device intended for medical purpose 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, Power Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-06.
The provided document is a 510(k) premarket notification for "Synthetic Powder Free (Pink) Vinyl Patient Examination Gloves." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, much of the information requested, such as multi-reader multi-case studies, effect sizes of AI assistance, and detailed ground truth establishment for large training sets, is not applicable to a device of this type (Class I patient examination gloves).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device are compliance with ASTM standard D-5250-06 and FDA requirements for patient examination gloves.
| Acceptance Criteria (Standard D-5250-06 unless otherwise specified) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Meets requirements |
| - Tensile Strength | Meets requirements |
| - Elongation | Meets requirements |
| - Dimensions (Length, Width, Thickness) | Meets requirements |
| - Inspection Level S-2, AQL 4.0 | Met |
| Pinhole Detection (Water Leak Test): | |
| - FDA 1000 ml. Water Fill Test | Meets requirements |
| - AQL 2.5, Inspection Level I | Met |
| Biocompatibility: | |
| - Primary Skin Irritation | No primary skin irritant reactions |
| - Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| Powder Content (Powder-Free Claim): | |
| - ASTM D-6124-06 for Starch (≤ 2 mg powder per glove) | Meets "powder-free" claims (≤ 2 mg powder per glove) |
| Labeling Compliance: | No special labeling claims, not claiming hypoallergenic |
| Applicable 21 CFR references | Conforms fully |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "samplings of AQL 2.5, inspection level I" for the water fill test and "Inspection level S-2, AQL 4.0" for physical and dimension testing. AQL (Acceptable Quality Limit) specifies the maximum proportion of defective units, and inspection levels relate to the sample size relative to the batch size, but the exact number of gloves sampled for each test is not explicitly stated in the provided document.
- Data Provenance: The tests were performed by Ever Light Plastic Products Co., Ltd. for their glove production. The country of origin of the data is China, where the manufacturer is located. The data is prospective in the sense that it was generated as part of the manufacturing and quality control process for these specific gloves to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in the context of this device. The "ground truth" for glove performance is established by the specified ASTM standards and FDA regulations, and the tests are typically performed by trained technicians in a laboratory setting, not by medical experts establishing a "diagnosis."
4. Adjudication Method for the Test Set:
This information is not applicable. The tests for glove performance involve objective measurements against predefined criteria (e.g., pass/fail for pinholes, quantitative measurement of tensile strength, powder content). There is no "adjudication" necessary in the sense of resolving disagreements among multiple experts.
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 information is not applicable. This is a physical medical device (patient examination glove), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on established industry standards (ASTM D-5250-06) and regulatory requirements (FDA's 21 CFR and specific test methods like the 1000 ml Water Fill Test). These standards define the acceptable physical properties, barrier integrity, and biocompatibility of examination gloves.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of a physical device like an examination glove. These devices are manufactured and tested against established specifications, not "trained" like a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As there is no training set for a physical device, the establishment of ground truth for such a set 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.