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510(k) Data Aggregation
(134 days)
The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is white. The subject device is non-sterile.
The provided document is a 510(k) summary for a Disposable Nitrile Medical Examination Glove. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. This document is not for an AI/ML medical device, but rather for a physical examination glove. Therefore, many of the requested criteria regarding AI/ML device acceptance, such as expert consensus, MRMC studies, training/test sets, and ground truth establishment, are not applicable to this submission.
However, I can extract and present the acceptance criteria and test results related to the physical and biocompatibility performance of the glove, as described in the document.
Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Glove (K210684)
The device, a "Disposable Nitrile Medical Examination Glove," is classified as Class I and its performance is evaluated against established ASTM and ISO standards for medical gloves, rather than complex AI/ML performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria Reported in Document | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):- XS/S: ≥220- M/L/XL: ≥230 | Length:- XS/S: > 220/Pass- M/L/XL: > 230/Pass |
| Width (mm):- XS: 70±10- S: 80±10- M: 95±10- L: 110±10- XL: 120±10 | Width:- XS: 78-80 / Pass- S: 85-89 /Pass- M: 95-99/ Pass- L: 105-111/ Pass- XL: 115-120/ Pass | ||
| Thickness (mm):- Finger: ≥0.05- Palm: ≥0.05 | Thickness:- Finger: 0.09-0.13/Pass- Palm: 0.07-0.13/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.07 mg/Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14 MPaUltimate Elongation: ≥500% | Tensile Strength:- XS:29-31/Pass- S:27-32/Pass- M:28-33/Pass- L:25-33/Pass- XL:28-31/PassUltimate Elongation:- XS:520-565/Pass- S:520-575/Pass- M:520-565/Pass- L:510-565/Pass- XL:525-563/Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14 MPaUltimate Elongation: ≥400% | Tensile Strength:- XS:26-31/Pass- S:28-32/Pass- M:27-31/Pass- L:28-33/Pass- XL:28-31/PassUltimate Elongation:- XS:480-520/Pass- S:490-525/Pass- M:485-530/Pass- L:490-545/Pass- XL:480-530/Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
Non-Applicable Criteria for this Device:
The following requested information is primarily relevant to AI/ML (Artificial Intelligence/Machine Learning) medical devices, which typically involve algorithms processing data (e.g., images, signals) to make predictions or assist in diagnoses. The submitted device, a medical examination glove, is a physical product and its testing is based on established performance standards for materials and manufacturing. Therefore, these items are not applicable to this 510(k) submission:
2. Sample size used for the test set and the data provenance: Not applicable. Tests are standard physical and chemical property evaluations on manufactured gloves, not a data-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is defined by physical/chemical standards, not expert medical opinion on a data set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. No AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on established international standards (ASTM, ISO) for physical properties and biocompatibility of medical gloves.
8. The sample size for the training set: Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary of Study (Non-Clinical Testing):
The study described is a series of non-clinical tests conducted to verify that the Disposable Nitrile Medical Examination Glove meets design specifications and complies with relevant international standards. The tests cover:
- Physical Dimensions: Length, width, and thickness for various glove sizes.
- Physical Properties: Tensile strength and ultimate elongation, both before and after accelerated aging, to assess durability and flexibility.
- Freedom from Holes: Watertightness testing to ensure barrier integrity.
- Powder Content: To confirm it is "powder free" as claimed.
- Biocompatibility: Tests for irritation, sensitization, and cytotoxicity to ensure the material is safe for contact with human skin.
The document reports that all tests demonstrated the proposed device complies with the specified standards and meets the acceptance criteria, leading to the conclusion that it is as safe and effective as the legally marketed predicate device.
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