(87 days)
Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only.
The provided document is a 510(k) summary for Nitrile Examination Gloves (Model: ZMG1351). It details the device's characteristics, comparison to a predicate device, and results from non-clinical testing. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension - ASTM D6319-19 | Evaluate the glove palm width | S: 80±10mm | |
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120±10mm | S: 84~86mm | ||
| M: 96~98mm | |||
| L: 104~106mm | |||
| XL: 113~115mm | |||
| Evaluate the glove length | S: Min 220mm | ||
| M: Min 230mm | |||
| L: Min 230mm | |||
| XL: Min 230mm | S: 241~251mm | ||
| M: 236~249mm | |||
| L: 237~245mm | |||
| XL: 240~249mm | |||
| Evaluate the glove finger thickness | S, M, L, XL: Min 0.05mm | S: 0.111~0.137mm | |
| M: 0.124~0.150mm | |||
| L: 0.112~0.133mm | |||
| XL: 0.117~0.137mm | |||
| Evaluate the glove palm thickness | S, M, L, XL: Min 0.05mm | S: 0.080~0.097mm | |
| M: 0.087~0.098mm | |||
| L: 0.074~0.086mm | |||
| XL: 0.077~0.094mm | |||
| Physical Properties - ASTM D6319-19 | Evaluate the glove physical properties before and after aging | Before Aging: |
- Tensile Strength: Min 14Mpa
- Ultimate Elongation: Min 500%
After Aging: - Tensile Strength: Min 14Mpa
- Ultimate Elongation: Min 400% | Before Aging:
- Tensile Strength: 19.9~27.4Mpa
- Ultimate Elongation: 509~553%
After Aging: - Tensile Strength: 20.1~35.1Mpa
- Ultimate Elongation: 454~504% |
| Freedom from Holes - ASTM D6319-19 | Detect the holes that allow water leakage | Do not show droplet, stream, or other type of water leakage (Pass at AQL 2.5, as per comparison table) | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
| Powder Residue - ASTM D6319-19 | Evaluate the residue powder | ≤2mg/glove | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
| Skin Irritation - ISO 10993-10:2010 | Evaluated for the potential to cause skin irritation | Under the condition of the test, not an irritant. | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
| Sensitization - ISO 10993-10:2010 | Evaluated for the potential to cause skin sensitization | Under the condition of the test, not a sensitizer. | No-sensitization (Performance reported as meeting the acceptance criteria as per "No- sensitization" in "Test Results" column and confirmation of compliance for all tests) |
| Acute Systemic Toxicity - ISO 10993-11:2017 | Evaluated for acute systemic toxicity | Under the condition of the test, not a systemic toxicity. | No-acute systemic toxicity (Performance reported as meeting the acceptance criteria as per "No- acute systemic toxicity" in "Test Results" column and confirmation of compliance for all tests) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each test. It simply states that "Bench tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly mentioned, but given the manufacturer (Wuhan Zonsen Medical Products Co.,Ltd) and contactor (Shanghai CV Technology Co., Ltd.) locations, it is highly likely the testing and data originated from China. The study appears to be retrospective in the sense that these are design verification tests performed on manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the document describes physical and biocompatibility testing of medical gloves, not an AI or diagnostic device that requires expert interpretation to establish a ground truth. The "ground truth" for these tests is based on established international standards (ASTM and ISO).
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as above. The tests performed are objective measurements against predefined criteria in established 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical product (nitrile examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the acceptance criteria and testing of the Nitrile Examination Gloves is based on established industry standards and protocols:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
The tests measure physical properties and biological responses against scientifically defined and accepted limits.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI or machine learning device. The tests are for product verification and validation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.