(134 days)
The Medical Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves and has different size specification and color. The proposed device is provided in non-sterile. The proposed device is made of Nitrile. The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D6319.
This document is a 510(k) Summary for Medical Nitrile Examination Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by relevant ASTM and ISO standards, and the device performance is reported as complying with these standards.
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance (Compliance/Result) |
|---|---|
| Physical Properties (Referencing ASTM D6319) | |
| Tensile Strength (Before Aging) - 14 MPa, min | 14 MPa, min (Applicant's device) |
| Ultimate Elongation (Before Aging) - 500% min | 500% min (Applicant's device) |
| Tensile Strength (After Aging) - 14 MPa, min | 14 MPa, min (Applicant's device) |
| Ultimate Elongation (After Aging) - 400% min | 400% min (Applicant's device) |
| Dimensions (Referencing ASTM D6319) | |
| Cuff Thickness, Palm Thickness, Finger Thickness - ≥ 0.05 mm | All proposed devices meet the specifications of ASTM D6319 (Table 1, indicates XS, S, U, M, L, XL, XXL all ≥ 0.05mm for Cuff, Palm, Finger Thickness) |
| Width - Specific values with ±10 mm tolerance (e.g., XS: 70±10, S: 80±10) | All proposed devices meet the specifications of ASTM D6319 (Table 1, indicates XS: 70±10, S: 80±10, U: 85±10, M: 95±10, L: 110±10, X-L: 120±10, XX-L: 130±10) |
| Length - Specific values (e.g., XS/S: ≥ 220 mm, U/M/L/XL/XXL: ≥ 230 mm) | All proposed devices meet the specifications of ASTM D6319 (Table 1, indicates XS/S: ≥ 220 mm, U/M/L/XL/XXL: ≥ 230 mm) |
| Freedom from Holes (Referencing ASTM D5151) | Be free from holes when tested in accordance with ASTM D5151 (Pinhole AQL 2.5) |
| Powder Content (Referencing ASTM D6124) | Less than 2 mg per glove when tested in accordance with ASTM D6124 |
| Biocompatibility (Referencing ISO 10993) | |
| Irritation (ISO 10993-10) - Not an irritant | Under the conditions of the study (ISO 10993-10), not an irritant |
| Sensitization (ISO 10993-10) - Not a sensitizer | Under conditions of the study (ISO 10993-10), not a sensitizer |
| Acute Systemic Toxicity (ISO 10993-11) - No mortality or systemic toxicity | Under the condition of the study (ISO 10993-11), there is no mortality or evidence of systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical properties, number of animals for biocompatibility tests). However, it implies that the tests were conducted according to the methodologies prescribed by the referenced standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11), which would include sample size requirements.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature of the data. However, the manufacturer is Jiangxi Hongda Medical Equipment Group Ltd. from China, and the testing results seem to be specific to their manufactured gloves. These appear to be prospective studies conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this type of device submission. The "ground truth" for medical gloves is established through objective physical, chemical, and biological testing against recognized international standards (ASTM and ISO), not through expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations are based on objective laboratory testing against predefined criteria in standards, not subjective assessments requiring expert adjudication.
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
This information is not applicable. This is a submission for medical gloves, a physical device, and does not involve AI software or human readers for diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a submission for medical gloves, a physical device, and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective measurements and laboratory testing results compared against the specifications defined in recognized international standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-17 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (medical gloves), not an AI algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
§ 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.