(73 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.
The provided text describes a 510(k) premarket notification for disposable powder-free vinyl synthetic exam gloves. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, not on proving effectiveness through clinical studies with specific acceptance criteria in the way a diagnostic or therapeutic AI device would.
Therefore, many of the requested points are not applicable to this type of device and submission. I will address the applicable points and note where information is not relevant to this submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing | ASTM D5250-06 (Inspection level S-2, AQL 4.0) | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0." Specific values are not provided, but the statement indicates conformance to the standard. |
| Watertight Test (Pinhole Detection) | ASTM D-5151-06 (AQL 2.5, Inspection level 1) | "The FDA 1000 ml Watertight Test based on ASTM D-5151-06 was also conducted with samplings of AQL 2.5, Inspection level 1, meeting these requirements." Specific failure rates or number of pinholes are not provided, but the statement indicates conformance to the standard. |
| Primary Skin Irritation | Not explicitly stated (implied "no primary skin irritant") | "results showing no primary skin irritant" |
| Skin Sensitization | Not explicitly stated (implied "no sensitization reactions") | "results showing no... sensitization reactions." |
| Residual Powder | ASTM D6124-06 (no more than 2 mg powder per glove) | "conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per gloves)" |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0." The exact sample size is not explicitly stated, but these are standard sampling plans (e.g., in accordance with ISO 2859-1 or similar). The data provenance is not specified beyond being generated by the device manufacturer, Rich Mountain Medical Products Inc.
- Watertight Test: "samplings of AQL 2.5, Inspection level 1." The exact sample size is not explicitly stated, but these are standard sampling plans. The data provenance is not specified.
- Primary Skin Irritation and Skin Sensitization: Sample size not specified.
- Residual Powder Test: Sample size not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This submission is for physical examination gloves, not an AI/ML device that requires expert-established ground truth for a test set. The tests performed are laboratory-based and involve physical properties and biocompatibility.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This is not an AI/ML algorithm; it is a physical medical device.
7. Type of Ground Truth Used
- Physical and Biocompatibility Test Results: The "ground truth" for this device comes from adherence to established engineering standards (ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06) and biocompatibility testing results (primary skin irritation and sensitization). These are objective measurements and assessments against predefined criteria.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in the context of machine learning. The manufacturing process is implicitly "trained" through quality control and adherence to standards, but not in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.