(20 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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 and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powdered Vinyl Patient Examination Gloves:
This document is a 510(k) premarket notification for a Class I medical device (Powdered Vinyl Patient Examination Gloves). For such devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally based on adherence to recognized standards and non-clinical testing rather than complex clinical studies with human participants. The focus is on demonstrating substantial equivalence to a predicate device and meeting established performance specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (based on ASTM D-5250-00E4) | All testing meets requirements for physical and dimensions testing. |
| Pinhole FDA Requirements (Water Fill Test) | FDA 1000 ml. Water Fill Test conducted with samplings of AQL 2.5, inspection level I, meeting these requirements. |
| Primary Skin Irritation | Results showing no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Results showing no sensitization reactions. |
| Residual Powder (Starch) (based on ASTM D-6124-06) | Conducted to insure gloves meet "powdered" claims (contain no more than 10mg/dm2). |
| Biocompatibility (General) | Meets biocompatibility requirements (implied by skin irritation/sensitization tests). |
| Labeling Claims | Meets labeling claims (no special claims, not hypoallergenic). |
2. Sample Size Used for the Test Set and Data Provenance
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Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of gloves tested is not specified but is determined by the AQL (Acceptable Quality Limit) standard for lot inspection.
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FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, inspection level I. The exact number of gloves tested is not specified, but indicated by the AQL standard.
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Primary Skin Irritation and Skin Sensitization Testing: The sample size for these tests (e.g., number of animals or human volunteers if applicable) is not specified in the document.
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Residual Powder Test: Not explicitly stated, but performed at "finished inspection" based on ASTM D-6124-06.
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Data Provenance: The document does not explicitly state the country of origin of the data (e.g., where the independent labs for skin testing were located). However, the manufacturing company is "Super Safe Plastic Products Co., Ltd." located in Shijiazhuang, Hebei, China. The testing would likely have been conducted in China or by labs contracted by the Chinese manufacturer.
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Retrospective or Prospective: These tests are prospective in nature, conducted specifically to demonstrate compliance for this device prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable in the traditional sense for this device. For Class I general-use products like examination gloves, "ground truth" is established by adherence to recognized consensus standards (like ASTM standards) and regulatory requirements (like FDA water fill tests).
- The tests are objective measurements against established thresholds, rather than subjective expert consensus on complex findings. For the skin irritation/sensitization tests, these would typically be conducted by qualified toxicologists or dermatologists, but their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
- Not Applicable in this context. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple experts review cases to establish a "ground truth" for diagnostic or prognostic endpoints.
- For these gloves, the "ground truth" is compliance with objective, quantifiable thresholds defined by ASTM standards and FDA test methods. The tests themselves are the "adjudicators" against a set standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant or required for a Class I patient examination glove. These studies are typically used to assess the impact of a diagnostic AI algorithm on human reader performance, which does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical product (gloves), not an AI algorithm. Therefore, "standalone algorithm performance" is not a concept that applies.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Industry Consensus Standards: Primarily ASTM D-5250-00E4 for physical and dimensional properties, and ASTM D-6124-06 for residual powder.
- Regulatory Requirements: FDA's 1000 ml Water Fill Test for pinholes.
- Biological Compatibility Testing Guidelines: Standard methods for assessing primary skin irritation and skin sensitization.
These act as the objective benchmarks against which the device's performance is measured.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not applicable.
§ 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.