(87 days)
The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document pertains to the 510(k) premarket notification for Nitrile Examination Gloves (K212922). This device is a Class I reserved medical device (non-powdered patient examination glove) and, as such, does not involve AI/ML technology or image analysis.
Therefore, the requested information regarding acceptance criteria, study details, human readers, ground truth establishment, etc., is not applicable to this type of medical device submission. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical properties and biocompatibility.
Here's a breakdown of why each point of your request is not relevant in this context:
- Acceptance Criteria and Reported Device Performance: This device is a physical product (gloves), not an AI/ML system. The acceptance criteria relate to physical and chemical properties like dimensions, tensile strength, freedom from holes, powder content, and biocompatibility, not measures like accuracy, sensitivity, or specificity of an algorithm.
- Sample size for the test set and data provenance: No "test set" in the context of AI/ML models exists. The testing involves physical samples of gloves.
- Number of experts and qualifications for ground truth: No "ground truth" in the AI/ML sense is established. The "ground truth" for gloves is adherence to physical and biocompatibility standards.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI/ML diagnostic or assistive device for human readers.
- Standalone (algorithm-only) performance: Not applicable, as there is no algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is established by adherence to recognized ASTM and ISO standards for glove manufacturing and safety (e.g., ASTM D6319, ASTM D5151, ISO 10993).
- Sample size for the training set: Not applicable, as there is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
Instead, the document details:
1. Acceptance Criteria and Reported Device Performance (Summary of Non-clinical Testing):
The acceptance criteria are derived from recognized standards like ASTM D6319 for physical dimensions, ASTM D5151 for watertightness, ASTM D6124 for powder content, and ASTM D412 for physical properties (tensile strength, ultimate elongation). Biocompatibility tests (ISO 10993-5, -10, -11) also have pass/fail criteria.
| Test Method | Purpose | Acceptance Criteria | Reported Performance / Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230 | |
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | |||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): S/M/L/XL: > 230/Pass | ||
| Width (mm): S: 80-90 /Pass; M: 85-96/ Pass; L: 101-115/ Pass; XL:110-122/ Pass | |||
| Thickness (mm): | |||
| S: Finger: 0.08-0.15/Pass; Palm: 0.07-0.08/Pass | |||
| M: Finger: 0.10-0.18/Pass; Palm: 0.07-0.11/Pass | |||
| L: Finger: 0.11-0.18/Pass; Palm: 0.07-0.08/Pass | |||
| XL: Finger: 0.11-0.13/Pass; Palm: 0.07-0.08/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures in a sample of 125, meeting the AQL of 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
§ 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.