(53 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 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 800.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
This document describes the acceptance criteria and study proving the device meets those criteria, specifically for Shijiazhuang Dilly Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical and Dimensions | ASTM-D-5250-92 | Meets standard | Meets all requirements |
| Pinhole Detection | FDA 1000 ml. Water Fill Test | AQL 2.5, Inspection Level S-4 | Meets requirements |
| Biocompatibility | Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Biocompatibility | Skin Sensitization (allergic contact dermatitis) | No sensitization reactions | No sensitization reactions |
| General Compliance | Applicable 21 CFR references | Adherence to regulations | Conforms fully |
| Labeling Claims | Specific labeling claims | No special claims, not hypoallergenic | No special labeling claims, not claimed as hypoallergenic |
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 provided, but these AQL levels dictate the sampling plan. Data provenance is not explicitly stated beyond being conducted by the manufacturer, Shijiazhuang Dilly Plastics Products Co., Ltd.
- FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. The specific number of gloves tested is not provided, but these AQL levels dictate the sampling plan. Data provenance is not explicitly stated beyond being conducted by the manufacturer.
- Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size (e.g., number of subjects, number of tests) for these biocompatibility tests, nor does it explicitly state the country of origin or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not Applicable. This document pertains to the 510(k) submission for patient examination gloves, which does not involve subjective diagnostic interpretations requiring expert consensus for ground truth establishment. The "ground truth" for these tests (e.g., pinhole presence, skin irritation) is based on objective measurements and established protocols.
4. Adjudication method for the test set:
- Not Applicable. As the device is examination gloves and the tests are objective physical and chemical assessments, there is no need for an adjudication method in the context of expert review or consensus, such as 2+1 or 3+1.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC comparative effectiveness study is not applicable for this type of device (patient examination gloves). These studies are typically used for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is patient examination gloves, not an algorithm or AI system. Therefore, a standalone performance evaluation of an algorithm is not relevant.
7. The type of ground truth used:
- The "ground truth" for the tests performed is based on:
- Objective measurements against established standards: For physical and dimensional properties, the ground truth is whether the glove meets the specifications of ASTM-D-5250-92.
- Objective experimental outcomes: For the pinhole test, the ground truth is whether water penetrates the glove under specified conditions. For biocompatibility, the ground truth is the presence or absence of a measurable irritating or sensitizing reaction.
8. The sample size for the training set:
- Not Applicable. This documentation is for a physical medical device (examination gloves), not an AI/ML algorithm that requires a training set. The tests performed are quality control and performance verification tests for manufactured products.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML algorithm or training set involved, the concept of establishing ground truth for a training set does not apply.
§ 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.