(496 days)
The Nitrile Patient Examination gloves. Powderfree. Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is non-sterile, powderfree and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM 06319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA.
The device is for over-the counter single use.
The provided document is a 510(k) premarket notification for Nitrile Patient Examination gloves. It does not describe an AI/ML medical device. Therefore, it is not possible to extract information related to AI/ML device acceptance criteria or studies proving device performance, as the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment, training set size) are not applicable to this type of medical device submission.
The document focuses on demonstrating substantial equivalence to a predicate device (K121947) through performance data based on established ASTM standards and biocompatibility tests for examination gloves.
Here's the relevant information that directly addresses the "acceptance criteria and the study that proves the device meets the acceptance criteria" for this non-AI/ML medical device:
1. A table of acceptance criteria and the reported device performance:
The document provides a detailed table comparing the subject device (Nitrile Patient Examination gloves, Powderfree, Blue color) to a legally marketed predicate device (ETS Blue Powderfree Nitrile patient exam glove, K121947) across various characteristics. The "Acceptance criteria/Standard" column outlines the benchmarks, typically ASTM standards or FDA guidance. The "SUBJECT DEVICE : K143477" column indicates the subject device's performance against these criteria, consistently stating "PASS" or meeting the specified physical properties.
| Characteristics | Acceptance Criteria/Standard | Reported Device Performance (Nitrile Patient Examination gloves, Powderfree, Blue color) |
|---|---|---|
| Freedom from Holes | ASTM D6319-10 / ASTM D5151-06 (FDA 1000 ml water leak test, ISO 2859-1 / G11 AQL 2.5) | Meets / PASS |
| Dimensions | ASTM D6319-10 (ISO 2859-1 / S2 AQL 4.0) - Length: min 230 mm (> 240-400mm met); Width: 70±10 mm to 120±10 mm (sizes XS to XL met); Thickness: > 0.05 mm (palm & finger met) | PASS |
| Physical Properties | Before aging: ASTM D6319-10 and ASTM D412-06 (ISO 2859-1 / S2 AQL 4.0) - Tensile strength: > 14 Mpa; Ultimate Elongation: > 500% | |
| After accelerated aging: ASTM D6319-10 and ASTM D412-06 (ISO 2859-1 / S2 AQL 4.0) - Tensile strength: > 14 Mpa; Ultimate Elongation: > 400% | PASS (Tensile strength: > 14 Mpa, Ultimate Elongation: > 500% before aging; Tensile strength: > 14 Mpa, Ultimate Elongation: > 400% after accelerated aging) | |
| Powder-free residue | ASTM D6319-10 / ASTM D6124-06 (N=5) - Less than 2 mg per glove | Meets / PASS (Less than 2 mg per glove) |
| Biocompatibility | ISO 10993-10 - Primary skin irritation (non-irritant); Skin/Dermal Sensitization (non-sensitizer) | Non-irritant; Non-sensitizer |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
| Intended Use | Medical Glove Guidance Manual (Intended for medical purpose to prevent contamination between patient and examiner) | Meets |
| Indication for Use | Medical Glove Guidance Manual (Disposable device for medical purposes, worn on hand/finger to prevent contamination) | Meets |
| Material | ASTM D6319-10, LZA product code (Nitrile synthetic latex) | Meets (Nitrile synthetic latex) |
| Non-sterile or sterile | Sterility (Non Sterile) | Non Sterile |
| Single Use | Disposable/Single use | Yes |
| Ambidextrous | ASTM D6319-0 | Yes |
2. Sample sized used for the test set and the data provenance:
The document refers to sampling plans and inspection levels for certain tests:
- Freedom from Pin holes: ISO 2859-1 / G11 AQL 2.5
- Dimensions: ISO 2859-1 / S2 AQL 4.0
- Physical Properties (Before and After aging): ISO 2859-1 / S2 AQL 4.0
- Powder-free residue: N=5 gloves
The exact numerical sample sizes for each test are not explicitly stated as absolute numbers but rather by the sampling plans (e.g., ISO 2859-1). The data provenance is not explicitly mentioned as "country of origin" for the test data, nor is it categorized as "retrospective or prospective." However, given the nature of the device (examination gloves) and the standards used, it's implied that these are laboratory tests performed on samples of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a non-AI/ML medical device submitting for 510(k) clearance. The "ground truth" for the physical and chemical properties of the gloves is established through adherence to defined ASTM and ISO standards and laboratory testing protocols, not by expert consensus or interpretations in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not an AI/ML device involving human interpretation that would require an adjudication method.
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:
Not applicable. This is a non-AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI/ML medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on established industry standards and validated laboratory test methods. This includes:
- ASTM International Standards: Such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D412-06 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM D7160-05 (Standard Practice for Determination of Expiration Dating for Medical Gloves).
- ISO Standards: Specifically ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization) for biocompatibility.
- FDA water leak test (1000ml).
8. The sample size for the training set:
Not applicable. This is a non-AI/ML medical device; therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this non-AI/ML medical 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.