(36 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 Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4
The device described is the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color. The submission is a 510(k) for substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (from ASTM D-5250-00E4 and FDA) | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing | Requirements of ASTM D-5250-00E4 | Meets all requirements (implicitly, as stated "All testing meets requirements") |
| Pinhole Detection (Water Fill Test) | AQL 2.5, Inspection Level G-1 (based on ASTM D-5151-99) | Meets these requirements |
| Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | No sensitization reactions |
| Residual Powder | No more than 2 mg powder per glove (ASTM D-6124-06 for Starch) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of items sampled is not explicitly stated but is determined by the AQL and inspection level. Data provenance is not specified but would typically be from the manufacturer's internal testing.
- Pinhole Detection (Water Fill Test): AQL 2.5, Inspection Level G-1. The specific number of items sampled is not explicitly stated. Data provenance is not specified.
- Primary Skin Irritation and Skin Sensitization: The sample size for these biological tests is not specified in the provided document. These tests are typically conducted in vitro or in vivo on animal models or human volunteers according to standard protocols. Data provenance is not specified.
- Residual Powder Test: The sample size is not specified. Data provenance is not specified.
All testing would be considered retrospective in the context of this submission, as they were performed prior to the submission for FDA clearance. The country of origin of the data is implied to be from the manufacturer's testing facilities, likely in China, given the submitter's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of device and submission. The "ground truth" for the performance tests (e.g., tensile strength, pinholes) is established by the objective physical and chemical testing methods and their predefined acceptance criteria, not by expert consensus on interpretations of complex data like medical images.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against predetermined standards, not subjective assessments requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images), and the AI's impact on reader performance is evaluated. Examination gloves do not involve such human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. The device is a physical product (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements and predefined standards.
- For physical properties and dimensions, the ground truth is derived from the ASTM D-5250-00E4 standard specifications.
- For pinhole detection, the ground truth is determined by the FDA 1000 ml. Water Fill Test based on ASTM D-5151-99.
- For biocompatibility (skin irritation and sensitization), the ground truth is established by the results of standardized biological assays that demonstrate no adverse reactions.
- For residual powder, the ground truth is based on the ASTM D-6124-06 standard for starch content.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is based on the manufacturing process and material characteristics, assessed through quality control and testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.