(63 days)
A patient examination glove is disposable device intended for medical a 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 Nitrile Examination Gloves (Blue, White), 80 LZA, and meets all requirements of ASTM standard D 6319-00a(2005).
The provided text describes the acceptance criteria and the study conducted for "Purtech Cleanroom Products Co., Ltd. Powder Free Nitrile Examination Gloves (Blue, White)."
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM D-6319-00a(2005) | Meets all requirements for physical and dimensions testing. |
| FDA 1000 ml. Water Fill Test | Meets requirements (AQL 2.5, inspection level I). |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions. |
| Residual Powder (ASTM D 6124-06) | Meets "powder-free" claims (≤ 2 mg powder per glove). |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical and Dimensions Testing (ASTM D-6319-00a(2005)): Inspection level S-2, AQL 4.0. (Specific sample size not provided, but indicated by the AQL and inspection level).
- FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, inspection level I. (Specific sample size not provided, but indicated by the AQL and inspection level).
- Primary Skin Irritation and Skin Sensitization Testing: The document does not specify the sample size for this testing.
- Residual Powder Test (ASTM D 6124-06): The document does not specify the sample size for this testing.
- Data Provenance: The tests are conducted on the manufacturer's own products and are non-clinical in vitro or ex vivo tests, not involving human subjects for retrospective or prospective studies in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a Class I medical device (patient examination gloves) and the testing described are non-clinical performance and safety tests (material properties, integrity, biocompatibility), not requiring expert-established ground truth in the context of clinical efficacy or diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable. The tests involve objective measurements against established standards (e.g., ASTM, FDA) for physical properties, integrity, and chemical residue, rather than subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is not relevant for the evaluation of examination gloves. MRMC studies are typically used to assess diagnostic devices where human readers interpret images or data, often with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical device (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the tests is derived from established national and international standards and methodologies for evaluating medical gloves:
- Standard ASTM D-6319-00a(2005): Defines the ground truth for physical and dimensional properties.
- FDA 1000 ml. Water Fill Test: Defines the ground truth for barrier integrity (pinhole detection).
- Biocompatibility Standards (Primary Skin Irritation, Skin Sensitization): Define the ground truth for safety in terms of skin reactions.
- ASTM D 6124-06: Defines the ground truth for acceptable residual powder levels for "powder-free" claims.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI or algorithm-based system that requires a training set. The "training" for the manufacturing process would be internal quality control and adherence to established specifications.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
§ 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.