(67 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER: CANAD
DISPOSABLE VINYL EXAM GLOVES, POWDERED
This is a letter from the FDA to Shanghai Antares Industries, Incorporated regarding their Disposable Vinyl Exam Gloves, Powdered. The letter approves the device for marketing and indicates it is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section specifies the intended purpose of the gloves.
Here's an analysis based on the provided text for the acceptance criteria and study, though not all requested information is present as this is a regulatory approval document and not a scientific study report:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Indications for Use: Prevent contamination between patient and examiner. | "A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER." (This is the stated intended use, implying the device performs this function.) |
| Material: Disposable Vinyl | "DISPOSABLE VINYL EXAM GLOVES, POWDERED" (Matches the device description.) |
| Form: Powdered Exam Gloves | "DISPOSABLE VINYL EXAM GLOVES, POWDERED" (Matches the device description.) |
Note: This document does not provide quantifiable performance metrics (e.g., tensile strength, barrier efficacy rates) that would typically be part of a detailed acceptance criterion table for a medical device. It primarily focuses on the regulatory clearance based on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance
- The document does not specify a sample size used for a test set. This is a 510(k) premarket notification approval, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed new clinical study data for device performance.
- The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. The submission is from Shanghai Antares Industries, Incorporated, China, P.R.C., suggesting any supporting data would likely originate from there or be based on existing literature/predicate device data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For a 510(k) submission, the "ground truth" often relates to the established performance and safety profile of the predicate device, or adherence to recognized standards.
4. Adjudication method for the test set
- The document does not describe any adjudication method for a test set.
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
- This is not applicable to this device (disposable vinyl exam gloves). This type of study is relevant for diagnostic imaging or AI-assisted interpretation tools, not for basic medical consumables. No MRMC study was done or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable to this device. No algorithm or AI component is mentioned or relevant to disposable exam gloves.
7. The type of ground truth used
- The implicit "ground truth" for a 510(k) submission like this is typically the established safety and effectiveness of the legally marketed predicate device to which the new device is compared as "substantially equivalent." It also relies on adherence to relevant manufacturing practices (GMP) and general controls. There is no mention of pathology, outcome data specific to this device, or expert consensus in the context of a new study for this specific approval.
8. The sample size for the training set
- The document does not specify a training set sample size. This concept is typically relevant for machine learning algorithms, which are not applicable here.
9. How the ground truth for the training set was established
- This is not applicable as there is no mention of a training set or machine learning.
§ 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.