(36 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06
Here's a breakdown of the acceptance criteria and study information for the Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powdered, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Device Performance (Test Results) | Notes |
|---|---|---|
| ASTM D5250-06 (General Requirements for Vinyl Patient Examination Gloves) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0. | This standard covers various physical properties and dimensions of the gloves. |
| FDA 1000 ml Watertight Test based on ASTM D-5151-06 (Pinhole Leakage) | Conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements. | This test assesses the integrity of the glove to prevent liquid penetration. |
| Biocompatibility (Primary Skin Irritation) | Results showing no primary skin irritant reactions. | Assesses potential for skin irritation upon contact. |
| Biocompatibility (Skin Sensitization/Allergic Contact Dermatitis) | Results showing no sensitization reactions. | Assesses potential for allergic reactions upon repeated contact. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set:
- For Physical and Dimensions Testing (ASTM D5250-06): Inspection level S-2, AQL 4.0. (The exact numerical sample size is not explicitly stated, but these AQL and inspection levels define the sampling plan.)
- For FDA 1000 ml Watertight Test (ASTM D-5151-06): AQL 2.5, Inspection level I. (Again, the exact numerical sample size is not explicitly stated, but these AQL and inspection levels define the sampling plan.)
- For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically tested on a defined number of subjects or animal models according to biocompatibility guidelines.
- Data Provenance: The document does not explicitly state the country of origin of the data for the testing. It is implied that the testing was conducted by or for Rich Mountain Medical Products Inc. which is based in China. The studies are prospective as they were conducted specifically for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This information is not applicable to this submission. The device is a medical glove, and the evaluation relies on adherence to established ASTM standards and FDA guidelines for physical properties, barrier integrity, and biocompatibility, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
- This information is not applicable. The testing involves objective measurements against predefined standards and biological responses rather than subjective expert evaluations requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD devices that assist human readers in interpreting medical data. The device here is a physical product (a glove) and does not involve AI or human readers for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone study was not done. This concept applies to AI algorithms. The device is a physical product.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by objective measurements and standardized test methods as defined by ASTM D5250-06 and ASTM D-5151-06, along with established protocols for biocompatibility testing. There is no expert consensus, pathology, or outcomes data used in the typical sense for diagnostic devices.
8. The Sample Size for the Training Set:
- This information is not applicable. The device is a physical product, not an AI model, therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no training set for a physical product like a medical glove.
§ 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.