(46 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 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, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
Here's a breakdown of the acceptance criteria and study information for the Ever Light Powdered (White) Vinyl Patient Examination Gloves, based on the provided text:
Device: Ever Light Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves
Predicate Device: Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | |
| (Based on ASTM-D-5250-00E4) | Meets all requirements for physical and dimensions testing conducted on gloves. (Inspection level S-2, AQL 4.0) |
| Pinhole / Water Leak Test: | |
| (FDA 1000 ml. Water Fill Test) | Meets requirements. (Sampling AQL 2.5, inspection level I) |
| Primary Skin Irritation: | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions. |
| Residual Powder Content: | |
| (Based on ASTM D-6124-06 for Starch) | Meets "powdered" claims (contains no more than 10mg/dm2). |
| Biocompatibility: | Meets biocompatibility requirements (as implied by skin irritation/sensitization results). |
| Labeling Compliance: | No special labeling claims; does not claim gloves as hypoallergenic. |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
- Pinhole / Water Leak Test: Sampling AQL 2.5, inspection level I. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
- Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size for the subjects/animals used in the tests.
- Residual Powder Test: "at finished inspection" (specific sample size not provided).
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of product testing for a 510(k) submission, these would typically be prospective tests conducted by the manufacturer or contracted labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The tests performed are laboratory and material property tests (e.g., physical dimensions, water-fill, chemical analysis, biocompatibility tests), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by direct measurement against defined ASTM or FDA standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations in clinical studies. The tests described are objective, pass/fail or quantitative measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is used to evaluate the diagnostic performance of a medical device (especially those involving image interpretation or clinical decision support) with and without AI assistance, typically involving human readers. The device in question is a patient examination glove, for which such a study is irrelevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This refers to AI algorithm performance. The device is a physical product (gloves) and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on established industry standards and regulatory requirements:
- ASTM-D-5250-00E4: For physical and dimensions testing.
- FDA 1000 ml. Water Fill Test: For pinhole detection.
- ASTM D-6124-06: For residual powder content.
- Biocompatibility testing guidelines: For primary skin irritation and sensitization.
Essentially, the "ground truth" is defined by these measurable standards and the outcome of the tests (e.g., whether a glove leaks, whether it irritates skin, whether it meets dimensional specifications).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for physical examination gloves. This concept applies to machine learning algorithms where data is used to train a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device type.
§ 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.