(102 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LZA; and meets all requirement of ASTM Standard D6319-10.
The document provided describes the acceptance criteria and study proving the device meets those criteria for the "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue Color" by Xinwei (Shandong) Plastic and Rubber Products Co., Ltd.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Predicate Device Performance | Proposed Device Performance |
|---|---|---|
| Indication for Use | Substantially equivalent | Disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner |
| Basic Design | Substantially equivalent | A garment covering the hand and wrist area. Gloves have separate sheaths or openings for each finger and the thumb. |
| Materials Used | Same (Nitrile Latex (NBR), Sulfur, Accelerator, ZDBC) | Nitrile Latex (NBR), Sulfur, Accelerator, ZDBC |
| Single Use | Yes | Yes |
| Sterile | Not sterile | Not sterile |
| Dimension | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical Property | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 or FDA 1000 ml. Water Fill Test with AOL 2.5, Inspection Level I |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 (no more than 2 mg powder per glove) |
| Primary Skin Irritation | ISO 10993-10 passes | ISO 10993-10 passes (no primary skin irritant reactions) |
| Dermal Sensitization | ISO 10993-10 passes | ISO 10993-10 passes (no sensitization reactions) |
| Tensile Strength | >14 MPa | >14 MPa |
| Ultimate elongation before aging | >500 | >500 |
| Ultimate elongation after aging | >500 | >500 |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "samplings of AOL 2.5, Inspection Level I" for the FDA 1000 ml. Water Fill Test and "Inspection Level S-2, AOL 2.5" for Physical and Dimension Testing. These are standard acceptance quality limits (AQLs) and inspection levels found in sampling plans (e.g., ISO 2859-1 or MIL-STD-105E). While the specific number of gloves sampled is not explicitly stated, these levels correspond to a defined sample size based on the lot size.
The data provenance is retrospective, as the tests were performed on finished products to demonstrate compliance with existing standards. The country of origin for the device manufacturer is China (Xinwei (Shandong) Plastic and Rubber Products Co., Ltd.), and the predicate device manufacturer is also from Tangshan Zhonghong Pulin Group Co., Ltd. (China, implied by other similar K-summaries for this manufacturer).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable to this type of device. The ground truth for this device is based on objective measurements against established engineering and biocompatibility standards, not expert medical opinion or diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable. This evaluation does not involve subjective interpretation requiring adjudication among experts. The tests are objective measurements.
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 or interpretive devices where human readers are involved in assessing cases, often with and without AI assistance. Examination gloves are physical barriers, not diagnostic tools.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or software requiring standalone performance testing. It is a physical product.
7. The Type of Ground Truth Used:
The ground truth used is based on established engineering standards and biocompatibility testing guidelines. Specifically:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
- ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves) or FDA 1000 ml. Water Fill Test for pinholes.
- ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
- ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) for primary skin irritation and dermal sensitization.
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.
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.