(62 days)
Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Vinyl Co-Polymer Powder-free Examination Gloves, Black are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.
The provided text is related to the FDA 510(k) premarket notification for "Vinyl Co-Polymer Powder-free Examination Gloves, Black". This document describes the device's technical specifications and how it compares to a predicate device. It also includes non-clinical performance data to demonstrate that the device meets established standards.
However, the request asks for specific information regarding acceptance criteria and a study proving a medical device meets those criteria, particularly in the context of AI/ML-assisted diagnostic tools (implied by questions about MRMC studies, human readers, ground truth establishment for training/test sets, etc.). The provided document is for examination gloves, which are Class I medical devices and do not involve AI, image analysis, or diagnostic capabilities in the way the questions are framed. Therefore, most of the requested information is not applicable to this submission.
I will fill in the relevant information that is present in the document and explicitly state when the requested information is not applicable due to the nature of the device.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250-19 | Length | Minimum 230mm | All size ≥230mm |
| ASTM D5250-19 | Palm Width (XS) | 75 ± 5 mm | 76-78mm |
| ASTM D5250-19 | Palm Width (S) | 85 ± 5 mm | 86-88mm |
| ASTM D5250-19 | Palm Width (M) | 95 ± 5 mm | 96-98mm |
| ASTM D5250-19 | Palm Width (L) | 105 ± 5 mm | 106-108mm |
| ASTM D5250-19 | Palm Width (XL) | 115 ± 5 mm | 116-118mm |
| ASTM D5250-19 | Thickness (Finger) | 0.08mm (min) | 0.08mm |
| ASTM D5250-19 | Thickness (Palm) | 0.08mm (min) | 0.08-0.10mm |
| ASTM D5250-19, ASTM D412-16 | Tensile Strength, Before Aging | 11MPa, min | 13.5-17.8 MPa |
| ASTM D5250-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 11MPa, min | 13.1-17.6 MPa |
| ASTM D5250-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 300%, min | 320-430% |
| ASTM D5250-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 300%, min | 310-420% |
| ASTM D5151-19, ASTM D65250-19 | Freedom from holes | G-I, AQL 2.5 | Meets AQL 2.5 requirements |
| ASTM D6124-06(2017), ASTM D5250-19 | Powder-Content | ≤2 mg per glove | 0.35-0.68 mg |
| 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| 10993-10:2010 | Maximization Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| 10993-5:2009 | In Vitro Cytotoxicity Test | No potential cytotoxicity to L929 cells | No potential cytotoxicity to L929 cells |
| ISO 10993 Part 11 | Acute Systemic Toxicity Test | No systemic toxicity | No systemic toxicity |
2. Sample sizes used for the test set and the data provenance
The document refers to "non-clinical tests" and "performance test data" but does not specify the exact sample sizes (e.g., number of gloves tested for each individual parameter). The tests conducted are standard physical and biocompatibility tests for examination gloves as per ASTM and ISO standards.
- Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the specifications of the referenced ASTM and ISO standards.
- Data Provenance: The manufacturing entity is Grand Work Plastic Products Co., Ltd in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing was presumably conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but for device development and regulatory submission, it would reflect tests performed on batches of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system that requires expert interpretation for ground truth establishment. The "ground truth" for these tests is based on objective physical, chemical, and biological measurements against established international standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic system requiring expert adjudication of results. Testing is based on laboratory measurements and adherence to specified tolerances.
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 device is an examination glove and does not involve human readers, AI assistance, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an examination glove and does not involve algorithms or standalone performance testing in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on:
- Physical and Mechanical Standards: Measurements of length, palm width, thickness, tensile strength, and elongation against specifications in ASTM D5250-19 and ASTM D412-16.
- Performance Standards: Freedom from holes (ASTM D5151-19, ASTM D65250-19) and powder content (ASTM D6124-06(2017), ASTM D5250-19).
- Biocompatibility Standards: Results from tests for skin irritation, sensitization (ISO 10993-10:2010), in vitro cytotoxicity (ISO 10993-5:2009), and acute systemic toxicity (ISO 10993 Part 11).
8. The sample size for the training set
Not applicable. This device is an examination glove and does not involve AI/ML models that require training sets.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, no ground truth establishment method for a training set is relevant.
§ 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.