(228 days)
The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.
Powdered Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the acceptance criteria and performance of the NitriTech® Non-Sterile Powdered Nitrile Examination Glove, as presented in the 510(k) summary K093516. It details the tests conducted to demonstrate substantial equivalence to a predicate device and adherence to relevant ASTM standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319-00a) | Reported Device Performance |
|---|---|---|
| 1. Detection of Holes (ASTM 5151) | Multiple Normal G1 AQL = 2.5 | Pass G1 AQL = 2.5 |
| 2. Length (mm) | ||
| Size XS | Min 220 | 240 mm minimum for all sizes |
| Size S | Min 220 | 240 mm minimum for all sizes |
| Size M | Min 230 | 240 mm minimum for all sizes |
| Size L | Min 230 | 240 mm minimum for all sizes |
| Size XL | Min 230 | 240 mm minimum for all sizes |
| 3. Palm Width (mm) | ||
| Size XS | 70 ± 10 | 73-78 |
| Size S | 80 ± 10 | 83-88 |
| Size M | 95 ± 10 | 93-98 |
| Size L | 110 ± 10 | 104-109 |
| Size XL | 120 ± 10 | 111-118 |
| 4. Thickness (mm) | ||
| Finger | Min 0.05 | Min 0.06 |
| Palm | Min 0.05 | Min 0.05 |
| 5. Physical Properties: Before Aging | ||
| Tensile Strength (Mpa) | Min 14 | 18-33 |
| Ultimate Elongation (%) | Min 500 | 500-630 |
| 5. Physical Properties: After Aging | ||
| Tensile Strength (Mpa) | Min 14 | 18-33 |
| Ultimate Elongation (%) | Min 400 | 500-610 |
| 6. Powder Content | Maximum is not Stated | Max 120 mg/glove |
| 7. Primary Skin Irritation (CPSC Title 16 Chapter II Part 1500) | PII Greater or equal to 5.0 indicates an irritant | PII was "0.04" (indicating no irritation) |
| 8. Dermal Sensitization Test (ISO 10993-10) | Score greater or equal to 1 indicates irritation/hypersensitivity | Score was "0" (indicating no irritation/hypersensitivity) |
Notes on Acceptance Criteria and Performance:
- For the "Length" and "Palm Width" tests, the reported performance is a range or a minimum value, which falls within or exceeds the specified ASTM criteria.
- For "Thickness (Finger)", the reported minimum performance (0.06mm) exceeds the ASTM minimum (0.05mm).
- For "Thickness (Palm)", the reported minimum performance (0.05mm) meets the ASTM minimum (0.05mm).
- For "Tensile Strength" (Before and After Aging), the reported range (18-33 Mpa) exceeds the ASTM minimum (14 Mpa).
- For "Ultimate Elongation" (Before Aging), the reported range (500-630%) meets or exceeds the ASTM minimum (500%).
- For "Ultimate Elongation" (After Aging), the reported range (500-610%) significantly exceeds the ASTM minimum (400%).
- "Powder Content" had no specific maximum stated in ASTM D6319-00a, but the device reports a maximum of 120mg/glove.
- For "Primary Skin Irritation" and "Dermal Sensitization", the reported scores are well below the thresholds indicating irritation or hypersensitivity, thus meeting the biocompatibility requirements.
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for each specific test (e.g., number of gloves tested for holes, length, etc.) are not explicitly stated in the provided 510(k) summary. The summary refers to "Third Party test data is available in Appendix A" and "Ammendment E", which would contain these specifics.
Data Provenance: The tests were conducted by a "Third Party" and "Mediamal Testing and Consultancy Services" for biocompatibility. The country of origin of this data is not specified within the provided text. The data is retrospective in the sense that the tests were performed on finished product samples prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a physical examination glove. The "ground truth" for its performance is established through standardized physical, chemical, and biological testing methods (ASTM, CPSC, ISO standards), not through expert consensus on interpretation. Therefore, no experts in a clinical interpretation sense were used to establish ground truth for this device performance data.
4. Adjudication Method for the Test Set
This is not applicable for the type of testing performed on an examination glove. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or imaging interpretation where there is subjective assessment that requires consensus. The performance tests for the glove are objective measurements (e.g., length, thickness, tensile strength, hole detection) or standardized biological assays with clear pass/fail criteria.
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 is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an examination glove, not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on established industry standards and objective measurements. Specifically:
- ASTM D6319-00a: Standard Specification for Nitrile Examination Gloves for Medical Application, which defines acceptable ranges and methods for physical properties (dimensions, thickness, tensile strength, elongation) and hole detection.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (used for tensile properties unaged).
- ASTM D573: Standard Test Method for Rubber—Deterioration in an Air Oven (used for tensile properties aged).
- ASTM D6124-06 Section 7 Procedure II: Standard Test Method for Residual Powder on Medical Gloves.
- CPSC Title 16 Chapter II Part 1500: Regulations for the Federal Hazardous Substances Act, specifically for Primary Skin Irritation.
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
These standards define the pass/fail criteria and acceptable limits, serving as the objective ground truth against which the glove's performance was measured.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (examination glove) and does not involve AI or machine learning, thus no "training set" in that context was used. The manufacturing process itself (Good Manufacturing Practices, or GMPs) ensures consistency, and quality control (QC) testing of batches ensures compliance with standards.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
§ 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.