(133 days)
A 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.
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
This response is tailored to a medical device's performance evaluation, specifically a Nitrile Examination Glove, based on the provided FDA 510(k) summary. The document describes the testing performed to demonstrate substantial equivalence to a predicate device, rather than a novel AI/software medical device. Therefore, aspects related to AI (e.g., human-in-the-loop, training/test sets, expert adjudication, MRMC studies) are not applicable and are addressed as such.
Here's the breakdown of the acceptance criteria and study proving device performance:
Device Name: Powder Free Blue Nitrile Examination Glove (K210375)
Predicate Device: Powder Free Blue Nitrile Examination Glove (K153562)
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is evaluated against established ASTM and ISO standards for examination gloves.
| Test Method (Reference Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6124 | To check the amount of powder residue from glove surface | Less than 2mg/glove | Pass (Average powder residue for each size: S: 0.61 mg/glove, M: 0.59 mg/glove, L: 0.57 mg/glove) |
| ASTM D5151 | To detect the presence of hole in glove | Meet AQL 2.5 from sampling of the lot | Pass |
| ASTM D6319 | To measure the following physical parameters of the glove: a) Length b) Palm Thickness c) Tensile Strength before age d) Tensile Strength after age e) Elongation before age f) Elongation after age | a) Length at minimum 230mm b) Palm Thickness at minimum 0.05mm c) Tensile strength before age at minimum 14MPa d) Tensile Strength after age at minimum 14MPa e) Elongation before age at minimum 500% f) Elongation after age at minimum 400% | Pass (Reported averages meet or exceed criteria for all sizes) |
| ISO 10993-10 | To determine the irritation potential of glove when exposed to skin surface (Primary Skin Irritation Test) and to evaluate potential for Type IV allergy (Skin Sensitization Test) | a) Not an Irritant b) Not a Sensitizer | Pass (Not an irritant, Not a sensitizer) |
| ISO 10993-11 | To evaluate the human hazard potential from glove (Acute Systemic Toxicity) | Not induce systemic toxicity | Pass (Did not induce systemic toxicity) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/ML device validating against a separate dataset. Instead, it refers to non-clinical tests performed on the "proposed device" (the Nitrile Examination Glove).
- Sample Size: The document does not explicitly state the sample sizes for each test (e.g., number of gloves tested for holes, tensile strength, etc.). However, it refers to standard practices like "sampling of the lot" for ASTM D5151 (Holes), and implies multiple samples for calculating averages for physical properties (D6319) and powder residue (D6124) across different glove sizes (S, M, L). For biocompatibility tests (ISO 10993), specific animal or in-vitro sample sizes are common for such assessments but are not detailed here. ASTM and ISO standards typically outline appropriate sampling plans.
- Data Provenance: The data is generated from performance testing of the "Powder Free Blue Nitrile Examination Glove" from Duramitt Sdn Bhd, located in Kulim, Kedah, Malaysia. These are prospective test results generated for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the described device is a physical medical glove, not an AI/software device that requires human expert annotation for establishing ground truth on a dataset. The "ground truth" for glove performance is established by standardized physical, chemical, and biological testing methods (e.g., measuring dimensions, tensile strength, conducting irritation tests in a lab setting) as per ASTM and ISO standards.
4. Adjudication Method for the Test Set
This section is not applicable. Since the device is a physical product and the "ground truth" is determined by objective, standardized laboratory tests, there is no need for expert adjudication of results as would be the case for subjective interpretations in an expert-based AI/ML ground truth dataset. Test results are quantified and compared to predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance for tasks involving interpretation (e.g., radiology image reading). This submission pertains to a physical medical glove, which does not involve human "readers" or AI assistance in its primary function or evaluation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
This section is not applicable. This concept applies to AI algorithms. The performance of the medical glove is evaluated as a standalone product based on its physical properties and biocompatibility as per the listed standards. There is no "algorithm" to evaluate.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by compliance with recognized international consensus standards (ASTM, ISO). These standards define objective, measurable criteria for physical properties (e.g., length, thickness, tensile strength, elongation), barrier integrity (freedom from holes), and biological safety (biocompatibility).
- Physical Properties: Measured directly (e.g., length, thickness) or through standardized mechanical testing (tensile strength, elongation).
- Barrier Integrity: Determined by a standardized water leak test (ASTM D5151).
- Biocompatibility: Assessed through standardized biological evaluation methods (ISO 10993-10 for irritation/sensitization, ISO 10993-11 for systemic toxicity), typically involving in-vitro or animal models as per the standard's guidelines.
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable. Since there is no training set (as this is not an AI/ML device), no ground truth establishment for such a set was performed.
§ 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.