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510(k) Data Aggregation
(118 days)
The Sterile Latex Examination Gloves Powder Free 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 Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation. The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.
The provided text describes the 510(k) summary for "Sterile Latex Examination Gloves Powder Free". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing, rather than an AI-driven medical device requiring extensive clinical validation of diagnostic accuracy. As such, many of the requested elements for AI/ML device studies (like sample sizes for test sets, expert ground truth adjudication, MRMC studies, training set details) are not applicable to the information provided.
However, I can extract the acceptance criteria and performance results for the non-clinical tests conducted for these gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Dimensions (width) | Evaluate the physical dimension of the glove | Width: | Pass | |
| S: 80 ± 10 mm | S: 81mm min | |||
| M: 95 ± 10 mm | M: 95mm min | |||
| L: 105 ± 10 mm | L: 106mm min | |||
| XL: 115 ± 10 mm | XL: 115mm min | |||
| Dimensions (length) | Evaluate the physical dimension of the glove | Length: 230mm min | 238mm min length | Pass |
| Dimensions (thickness) | Evaluate the physical dimension of the glove | Palm – 0.08mm min.Finger – 0.08mm min. | Palm – 0.11mm min.Finger – 0.11mm min | Pass |
| Physical properties (Before aging) | Evaluate tensile strength and ultimate elongation before aging | Tensile Strength: 18 MPa, min.Elongation: 650%, min.Stress at 500% Elongation: 5.5MPa, max. | Tensile Strength: 23.4MPa, min.Elongation: 650%, min.Stress at 500% Elongation: 5.3MPa, max. | Pass |
| Physical properties (After aging) | Evaluate tensile strength and ultimate elongation after aging | Tensile Strength: 14 MPa, min.Elongation: 500%, min. | Tensile Strength: 22MPa, min.Elongation: 704%, min. | Pass |
| Freedom from holes | Detect holes in the gloves | No leakage at sampling level of G-1, AQL 1.5 | No leakage, 314 of 315 passed | Pass |
| Residual Powder | Detect powder residue in the glove | <2mg per glove | Average 0.09 mg per glove | Pass |
| Residual Protein | Detect protein residue in the glove | <200µg/dm² | Average 70.880µg/dm² | Pass |
| Sterility | Detect the sterility of the glove | Sterile | Sterile | Pass |
| Irritation (ISO 10993-10) | Demonstrate the safety of the subject device (biocompatibility) | Under the conditions of the study, not an irritant. Comply with ISO 10993-10. | Under the conditions of the study, not an irritant. Comply with ISO 10993-10. | Pass |
| Sensitization (ISO 10993-10) | Demonstrate the safety of the subject device (biocompatibility) | Under the conditions of the study, not a sensitizer. Comply with ISO 10993-10. | Under the conditions of the study, not a sensitizer. Comply with ISO 10993-10. | Pass |
| Acute systemic toxicity (ISO 10993-11) | Demonstrate the safety of the subject device (biocompatibility) | Under the conditions of the study, the device does not induce acute systemic toxicity | Under the conditions of the study, the device does not induce acute systemic toxicity | Pass |
Since this is not an AI/ML-driven medical device, the following sections are either not applicable (N/A) or the information is not provided in the document:
2. Sample size used for the test set and the data provenance:
- For the Freedom from holes test, the document states "314 of 315 passed," implying a test set size of 315 gloves for this specific attribute.
- For other physical and material property tests (Dimensions, Physical Properties, Residual Powder, Residual Protein, Sterility), specific sample sizes are not explicitly stated, but standard testing procedures for medical devices of this type would typically involve a statistically appropriate random sample from production lots.
- Data provenance (country of origin, retrospective/prospective) is not specified for the test data, but the manufacturer is based in China. This is a non-clinical/material performance study.
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):
- N/A. This is a physical product, and ground truth is established through standardized laboratory testing methods (e.g., ASTM and ISO standards), not human expert interpretation of images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Ground truth is determined by objective laboratory measurements and tests according to cited standards, not by human adjudication of ambiguous cases.
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:
- N/A. This is not an AI/ML device; therefore, MRMC studies involving human readers are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML device. The "standalone" performance refers to the device's inherent physical and material properties when tested according to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth for this device is based on objective measurements and results from standardized laboratory testing protocols as defined by ASTM International and ISO standards (e.g., ASTM D3578-19, ASTM D6124-06, ASTM D5151-19, ASTM D5712-15, ISO 10993-10, ISO 10993-11, ISO 11137-1, ISO 11137-2).
8. The sample size for the training set:
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- N/A. This device does not involve a "training set" or "ground truth establishment" for training purposes as understood in AI/ML.
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