(61 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
This document is a 510(k) summary for a "Powder Free Vinyl Patient Examination Glove," which is a Class I medical device. The document primarily focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with relevant ASTM standards and FDA requirements. It does not present a study proving the device meets acceptance criteria in the typical sense of a clinical or AI-based diagnostic device study.
Instead, the "acceptance criteria" here refer to the performance standards and tests required for this type of medical glove to be marketed. The "study" refers to the non-clinical tests performed to demonstrate compliance with these standards.
Here's the breakdown of the information requested, tailored to the context of this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D5250-06e1 Standard for Vinyl Patient Examination Gloves (General Requirements) | All testing meets requirements for physical and dimension testing conducted on gloves. |
| FDA 1000 ml. Water Fill Test (Pinhole integrity) | Samplings (AQL 2.5, inspection level I) meet requirements. |
| Primary Skin Irritation Test | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) Test | No sensitization reactions. |
| Residual Powder Test (ASTM D6124-06) | Gloves meet "powder-free" claims (contain no more than 2 mg powder per glove). |
| Biocompatibility Requirements | Met (implied by skin irritation/sensitization tests). |
| Labeling Claims | No special labeling claims; not claimed as hypoallergenic. |
2. Sample Size Used for the Test Set and Data Provenance
- ASTM D5250-06e1 (Physical and Dimensions Testing): Inspection level S-2, AQL 4.0. (Specific sample size not explicitly stated, but these AQL values dictate the sampling plan).
- FDA 1000 ml. Water Fill Test: Inspection level I, AQL 2.5. (Specific sample size not explicitly stated, but these AQL values dictate the sampling plan).
- Biocompatibility Tests (Skin Irritation and Sensitization): Sample size for testing on subjects is not specified.
- Residual Powder Test (ASTM D6124-06): Sample size not specified.
- Data Provenance: The document does not specify the country of origin for the testing or if it was retrospective or prospective. Given it's a 510(k) submission, the testing would be conducted prospectively to demonstrate compliance before market entry.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical product (medical glove) and not a diagnostic device that requires expert interpretation for a "ground truth." The "ground truth" for these tests comes from objective measurements against established ASTM standards and FDA requirements.
4. Adjudication Method for the Test Set
- Not Applicable. As explained above, this is about objective measurements against standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance
- Not Applicable. This is a medical glove, not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Not Applicable. This is a medical glove, not an algorithm/AI.
7. The Type of Ground Truth Used
- The "ground truth" for this device is based on objective measurements and adherence to established industry standards (ASTM D5250-06e1, ASTM D6124-06) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility criteria).
8. The Sample Size for the Training Set
- Not Applicable. This is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, there is no "training set" for this type of device.
§ 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.