(85 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, (Yellow, white, blue, pink), 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
Here's a breakdown of the acceptance criteria and study information for the Better Care Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, based on the provided K092301 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Performance Standard / AQL | Reported Device Performance (Meets/Fails) |
|---|---|---|
| Physical and Dimensions Testing | ASTM-D-5250-06e1 | Meets requirements |
| Pinhole Detection (Water Fill Test) | AQL 2.5, Inspection Level I | Meets requirements |
| Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | No sensitization reactions |
| Residual Powder | No more than 2 mg powder per glove (ASTM D-6124-06) | Meets "powder-free" claims |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of gloves tested is not explicitly stated, but it would be determined by the sampling plan outlined in ASTM-D-5250-06e1 for an AQL of 4.0 at an S-2 inspection level.
- Pinhole Detection (Water Fill Test): AQL 2.5, Inspection Level I. The specific number of gloves tested is not explicitly stated, but it would be determined by the sampling plan for an AQL of 2.5 at an Inspection Level I.
- Primary Skin Irritation and Skin Sensitization: The document states "testing was conducted" but does not specify the sample size (e.g., number of subjects or samples) used for these biocompatibility tests.
- Residual Powder Test: Based on ASTM D-6124-06. The number of gloves tested for residual powder is not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the data or if the studies were retrospective or prospective. Given that this is a 510(k) for a manufacturing company, it's likely that the tests were conducted by or on behalf of the manufacturer to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (patient examination gloves) does not typically involve human experts establishing "ground truth" in the way an AI diagnostic device would. The "ground truth" for these tests is established by objective, standardized laboratory measurements and compliance with industry standards (e.g., ASTM standards, AQL limits for defects). There are no "experts" in the sense of clinicians interpreting results for a test set.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective laboratory tests with defined pass/fail criteria based on standards. There is no subjective interpretation requiring adjudication among multiple readers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for AI devices that assist human readers in tasks like image interpretation. This device is a physical product (gloves), and its performance is evaluated through material and quality control tests, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The tests performed (physical, dimensions, pinhole, biocompatibility, residual powder) evaluate the intrinsic properties and performance of the glove itself, without any human-in-the-loop or interpretive component in the way an algorithm would be evaluated. The "device" (glove) is tested in a standalone manner against defined physical and chemical parameters.
7. The Type of Ground Truth Used
The ground truth used for these tests is objective, standardized measurements and compliance with established industry standards.
- For physical properties and dimensions, the ground truth is defined by the tolerances and specifications within ASTM-D-5250-06e1.
- For pinholes, the ground truth is defined by the FDA 1000 ml. Water Fill Test and its AQL 2.5 acceptance criterion.
- For biocompatibility (skin irritation and sensitization), the ground truth is established by the absence of adverse reactions in standardized biological tests.
- For residual powder, the ground truth is the quantitative measurement of powder content against the 2 mg per glove limit specified by ASTM D-6124-06.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.