(134 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.(21 CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Examination Vinyl Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
The provided 510(k) summary is for the Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue. As such, the "device" in this context refers to these gloves. This document describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study of an AI algorithm. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to this type of medical device submission.
Here's the information extracted from the document, focusing on the acceptance criteria and the study (non-clinical testing) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on the ASTM-D-5250-06 standard for examination vinyl gloves, and FDA requirements for pinholes and biocompatibility. The reported device performance is compared to the predicate device, which implicitly meets these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Synmax Synthetic Examination Vinyl Gloves) |
|---|---|
| ASTM-D-5250-06 Compliance | Conforms fully to ASTM-D-5250-06 standard |
| Overall Pinhole AQL 2.5 (FDA 1000 ml. Water Fill Test, Inspection Level I) | Meets these requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| Powder Content (for "powder-free" claim) | Contains no more than 2 mg powder per glove |
| Physical Dimensions (for Medium Size, based on comparison to predicate, implied to meet standards) | |
| Overall Length | Average over 230mm |
| Width of Palm | Average 95mm |
| Palm Thickness | Average 0.095 mm |
| Finger Thickness | Average 0.090 mm |
| Material Properties (Before Aging, based on comparison to predicate, implied to meet standards) | |
| Average Tensile Strength (Mpa) | 16.9 |
| Average Ultimate Elongations (%) | 550% |
| Material Properties (After Aging, based on comparison to predicate, implied to meet standards) | |
| Average Tensile Strength (Mpa) | 14.4 |
| Average Ultimate Elongations (%) | 500% |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a single "test set" sample size. For physical and dimensions testing, the inspection levels are S-2, AQL 2.5. For the FDA 1000 ml. Water Fill Test (pinhole), the inspection level is I, AQL 2.5. These are industry standard sampling plans, but the specific number of gloves sampled is not provided in this summary.
- Data Provenance: The tests were conducted by Zibo Intco Medical Products, Co. Ltd. (the manufacturer) in China. The data is prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/diagnostic device that requires expert ground truth establishment in the traditional sense. The "ground truth" for glove performance is determined by established engineering and material science standards (ASTM, FDA water fill test).
4. Adjudication method for the test set
Not applicable. This is not an AI/diagnostic device. Performance is measured against objective standards.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is based on:
- Industry Standards: ASTM D5250-06 for physical properties and dimensions.
- Regulatory Requirements: FDA 1000 ml. Water Fill Test for pinhole integrity.
- Biocompatibility Testing: Primary Skin Irritation and Skin Sensitization tests (in vivo tests on biological systems, typically animals or human volunteers for patches, but the document doesn't specify for this case, only "with results showing no primary skin irritant or sensitization reactions").
- Chemical Analysis: Measurement of powder content (no more than 2 mg/glove).
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.