(268 days)
The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.
The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves Biodegradable (Green). It describes the device, its intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This document pertains to a medical device (examination gloves) that is a physical product, not an AI/software-based device. Therefore, several of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable in this context, as they relate specifically to the validation of AI/ML systems or diagnostic aids, not physical medical devices like gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves and biocompatibility.
| Characteristic | Test Methodology / Standard | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|---|
| Dimensions | ASTM D6319-19 | (S) Length: Min 230mm, Width: 80±10mm | |
| (M) Length: Min 230mm, Width: 95±10mm | |||
| (L) Length: Min 230mm, Width: 105±5mm | |||
| (XL) Length: Min 230mm, Width: 115±5mm | |||
| (XXL) Length: Min 230mm, Width: >120mm | (S) Average: Length 246mm, Width 86mm | ||
| (M) Average: Length 246mm, Width 99mm | |||
| (L) Average: Length 246mm, Width 106mm | |||
| (XL) Average: Length 250mm, Width 115mm | |||
| (XXL) Average: Length 254mm, Width 125mm | |||
| Material Thickness | ASTM D6319-19 | Palm & Finger: Min 0.05mm | (S) Palm 0.13mm, Finger 0.19mm |
| (M) Palm 0.13mm, Finger 0.19mm | |||
| (L) Palm 0.13mm, Finger 0.18mm | |||
| (XL) Palm 0.13mm, Finger 0.17mm | |||
| (XXL) Palm 0.12mm, Finger 0.19mm | |||
| Physical Properties (Tensile Strength) | ASTM D6319-19 | Before Aging: ≥14MPa | |
| After Aging: ≥14MPa | M: Before Aging 29.95MPa, After Aging 29.66MPa (Only M size reported) | ||
| Physical Properties (Ultimate Elongation) | ASTM D6319-19 | Before Aging: ≥500% | |
| After Aging: ≥400% | M: Before Aging 561%, After Aging 496% (Only M size reported) | ||
| Hole Detection (Watertight) | ASTM D5151-19, 21 CFR 800.20 | AQL 1.5 | All sizes (S, M, L, XL, XXL) Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06(2022) | Max - 2 mg/glove | 0.36 mg/glove |
| Biodegradation | ASTM D5511-18 | Tested (Specific % is not an 'acceptance criterion' but a 'result' of testing) | Adjusted Percent Biodegraded (%): 7.2 |
| Biocompatibility - Cytotoxicity | ISO 10993-5 | Not explicitly stated as a numeric criterion, but expectation of low/no reactivity | Mild cytotoxicity reactivity result (2) with the neat extract (100%). (This indicates a mild reaction but is often acceptable depending on the product and risk assessment) |
| Biocompatibility - Skin Sensitization | ISO 10993-10:2021 | Not explicitly stated, but expectation of non-sensitizing | Extracts are not sensitizing to the animal model. |
| Biocompatibility - Irritation | ISO 10993-23:2021 | Not explicitly stated, but expectation of non-irritating | Device is non-irritating, extracts are not irritating to the animal model. |
| Biocompatibility - Systemic Toxicity | ISO 10993-11:2017 | Not explicitly stated, but expectation of no acute toxic reaction | Did not demonstrate any acute toxic reaction. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests are conducted according to recognized standards (ASTM, ISO), which inherently specify sampling plans and test methods (e.g., AQL 1.5 for hole detection typically implies a specific sampling size based on lot size).
- Data Provenance: The tests were conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The data appears to be prospective as it directly supports the 510(k) submission for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. For a physical product like medical gloves, "ground truth" is established through standardized physical, chemical, and biological testing methods (e.g., measuring dimensions, tensile strength, or observing biological reactions in animal models), not through expert consensus on interpretations like with AI/imaging data. The standards themselves define the "ground truth" for compliance.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for subjective human assessments, particularly in image interpretation or clinical diagnosis. For physical and chemical property testing of gloves, the results are typically objective measurements or observations by trained laboratory personnel following the specified test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
Not Applicable. MRMC studies are used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing human reader performance with and without the system. This is not relevant for a physical product like examination gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not Applicable. "Standalone" performance refers to the diagnostic capability of an algorithm or AI without human interaction. This concept does not apply to a physical medical device. The device's performance is intrinsically linked to its physical and material properties.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements and observations derived from:
- Standardized Test Methods: Adherence to established and recognized international standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D5511-18, ASTM D6124-06(2022), ISO 10993 series). These standards define the test procedures and acceptance criteria for various physical, chemical, and biological properties.
- Direct Physical and Chemical Analysis: Measurements of dimensions, tensile strength, elongation, residual powder, and observations of biodegradation and biocompatibility reactions.
- Biological Endpoints: For biocompatibility, the ground truth is based on the observed biological response (e.g., presence/absence of irritation, sensitization, or systemic toxicity) in established animal or in-vitro models as per ISO 10993.
8. The Sample Size for the Training Set
Not Applicable. The concept of a "training set" (for machine learning models) does not apply to the development or validation of a physical medical device like these gloves. The manufacturing process is controlled by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation), and product performance is validated through testing of manufactured lots against specifications, not through machine learning.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As mentioned above, there is no "training set" in the context of this device. The physical and performance characteristics are inherent to the material and manufacturing process, validated through testing against pre-defined standards.
§ 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.