(47 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 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, Powder-Free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
The provided text is a 510(k) summary for "Shanghai Super Gloves Co., Ltd. Powder-Free Vinyl Patient Examination Gloves." This document describes the device, its intended use, and its comparison to predicate devices, along with non-clinical tests performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Performance/Result Reported |
|---|---|
| ASTM D5250-92 | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0." Also, "Shanghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves conform fully to ASTM-D-5250-92 standards..." |
| FDA 1000 ml. Water Fill Test | "Also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements." This test assesses the integrity of the glove (e.g., pinholes). |
| Primary Skin Irritation | "Testing was conducted with results showing no primary skin irritant reactions." |
| Skin Sensitization (allergic contact dermatitis) | "Testing was conducted with results showing no... sensitization reactions." |
| USP Iodine Test (for starch content) | "A USP Iodine conducted to insure that our gloves meet our 'powder-free' claim. We adhere to all USP Iodine Test methodology and testing conducted revealed passing results." |
| Biocompatibility requirements | "...meets... biocompatibility requirements..." (General statement, no specific test details provided beyond skin irritation/sensitization). |
| Labeling Requirements | "...meets... labeling requirements..." (General statement). |
2. Sample Size Used for the Test Set and the Data Provenance
- ASTM D5250-92 (Physical and Dimensions Testing): Inspection Level S-2, AQL 4.0. (This describes the sampling plan, but not the absolute number of samples.)
- FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. (This describes the sampling plan, but not the absolute number of samples.)
- Primary Skin Irritation and Skin Sensitization: The document states "testing was conducted" but does not specify the sample size or provenance (e.g., country of origin, retrospective/prospective).
- USP Iodine Test: The document states "testing conducted" but does not specify the sample size or provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of experts or ground truth establishment in the context typically seen for diagnostic or AI-driven devices. The tests performed are objective, laboratory-based conformity assessments against established standards for medical gloves.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective measurements against predefined standards (e.g., ASTM, FDA water fill test, USP Iodine test). There is no "adjudication" in the sense of expert consensus on qualitative data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document describes the testing for a medical glove, not a diagnostic or AI-assisted device that would typically undergo MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
No. This is not an AI/algorithm-driven device.
7. The type of ground truth used
The "ground truth" for this device is defined by the established performance standards and test methodologies (e.g., ASTM D5250-92 for physical properties, FDA 1000 ml Water Fill Test for pinholes, USP Iodine Test for powder residue, and standard biocompatibility testing for skin reactions). These are objective criteria.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
§ 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.