(43 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, 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 Ever Light Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves:
Device: Ever Light Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Name | Standard / Requirement | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing (General) | ASTM-D-5250-00E4 | Meets requirements for physical and dimensions testing. |
| Physical and Dimensions Testing (AQL) | Inspection level S-2, AQL 4.0 | Meets requirements. |
| Pinhole Test (Water Fill Test) | FDA 1000 ml. Water Fill Test, AQL 2.5, inspection level I | Meets requirements. |
| Primary Skin Irritation | Not explicitly stated, implied to prevent irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Not explicitly stated, implied to prevent sensitization | No sensitization reactions. |
| Residual Powder Test | ASTM D6124-06 (for Starch), ≤ 2 mg powder per glove | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility | Applicable 21 CFR references (implied requirement for patient contact devices) | Meets biocompatibility requirements. |
| General Safety/Efficacy | Substantial equivalence to predicate device (K000071), no new claims | No safety/efficacy issues or new claims compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The text does not provide a specific number of gloves, but specifies the AQL (Acceptable Quality Level) and inspection level, which are standard statistical sampling methods for quality control. This is likely a retrospective evaluation of manufacturing batches.
- Pinhole Test (Water Fill Test): AQL 2.5, inspection level I. Similar to the above, a specific number isn't given, but the sampling plan is defined. This is likely a retrospective evaluation of manufacturing batches.
- Primary Skin Irritation and Skin Sensitization: The text states these tests were "conducted" but does not specify the sample size of subjects or the exact provenance of the data (e.g., specific country or demographic). It's broadly a prospective test on human or animal subjects to assess biological response.
- Residual Powder Test: The test is "conducted at finished inspection" to ensure compliance. The sample size or specific provenance isn't detailed, but it's part of standard retrospective quality control during manufacturing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The tests described are primarily objective, quantitative measurements (e.g., physical dimensions, water-fill, chemical analysis, biocompatibility assessments). They do not rely on expert consensus for "ground truth" in the way a diagnostic imaging study would. The data is generated directly from laboratory testing and quality control processes.
4. Adjudication Method for the Test Set:
- Not applicable. As the tests are objective measurements, there is no need for expert adjudication in the traditional sense (e.g., comparing expert reads to an algorithm's output). The results are determined by adherence to pre-defined numerical or qualitative standards (e.g., "no primary skin irritant reactions," "meets requirements," "no more than 2 mg powder per glove").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is typically performed for diagnostic devices (e.g., AI in radiology) where human readers interpret data, and the AI's impact on their performance is evaluated. This device is a patient examination glove, and the tests relate to its physical properties, barrier function, and biological compatibility, not its interpretation performance.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Study Was Done:
- No. This device is a physical product, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance described is the inherent performance of the physical glove itself.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by:
- External Standards: Adherence to established industry standards like ASTM-D-5250-00E4 for physical properties and dimensions, and ASTM D6124-06 for residual powder.
- Regulatory Requirements: Meeting FDA's 1000 ml. Water Fill Test requirements for barrier integrity and general 21 CFR references for biocompatibility.
- Direct Laboratory Measurements/Observations: Results from primary skin irritation and sensitization tests (direct observation of biological response).
- Predicate Device Equivalence: The ultimate "ground truth" for market clearance is demonstrating substantial equivalence to a legally marketed predicate device (K000071) where those benchmarks established its safety and effectiveness.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set." The testing described relates to product quality control and performance validation, not algorithm development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an algorithm, this question is not relevant to the described device and studies.
§ 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.