(613 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, and meets all requirement of ASTM Standard D5250-06. The subject device is a garment covering the hand and wrist area. Clovers have separate sheaths or openings for each finger and the thumb. And vinyl films form a barrier to body fluid and blood-borne pathogens, and that the vinyl rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
The acceptance criteria and device performance information from the provided text are summarized below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM-D-5250-06 unless otherwise specified) | Reported Device Performance (Shandong Yifan Plastic Products Co., Ltd.) |
|---|---|
| Before Aging: | |
| Tensile Strength (Mpa) | Average Tensile Strength: 16.9 Mpa |
| Ultimate Elongations (%) | Average Ultimate Elongations: 550% |
| After Aging: | |
| Tensile Strength (Mpa) | Average Tensile Strength: 14.4 Mpa |
| Ultimate Elongations (%) | Average Ultimate Elongations: 500% |
| Overall Length on Medium Size | Average over 230mm |
| Width of Palm on Medium Size | Average 95mm |
| Palm Thickness | Average 0.085 mm |
| Finger Thickness | Average 0.090 mm |
| Residual Powder (per ASTM D6124-06) | ≤ 2 mg per glove |
| Pinhole Results (ASTM D5151-06, AQL 2.5) | Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met. |
| Biocompatibility: Primary Skin Irritation | Not an irritant |
| Biocompatibility: Dermal Sensitization | Not a sensitizer |
| Water Tightness (FDA 1000 ml. Water Fill Test, AQL 2.5, Inspection Level I) | Meeting these requirements (Implied pass based on "meeting these requirements") |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size:
- For Pinhole Results (ASTM D5151-06): At least 125 pieces of gloves were tested.
- For Water Fill Test: Specific sample size not explicitly stated, but performed with "samplings of AQL 2.5, Inspection Level I."
- For Physical and Dimensions Testing: "Inspection Level S-2, AQL 2.5" was used, which implies a sample size determined by these AQL standards, but the exact number isn't quantified.
- Data Provenance: The document does not specify the country of origin of the data for these tests. It implies these were internal tests conducted by the manufacturer, Shandong Yifan Plastic Products Co., Ltd., based in Zibo City, Shandong, China. The tests are presented as being conducted to demonstrate substantial equivalence, suggesting they were prospective tests performed on the device prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This device (patient examination gloves) is a Class I medical device and typically does not involve human expert interpretation for establishing the "ground truth" in the same way an AI diagnostic device would. The "ground truth" is established by direct physical measurements and standardized chemical/biological tests. Therefore, this section is not applicable in the context of this device and report. The tests performed are objective, measurable physical properties and biocompatibility assessments.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements (e.g., tensile strength, dimensions, pinhole count, chemical content) or standard biological assays (e.g., skin irritation, sensitization) that result in direct numerical or categorical outcomes, not requiring expert adjudication of subjective interpretations.
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 images or data, and an AI would assist or replace them. For patient examination gloves, such a study is not applicable.
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 algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device is established through:
- Objective Physical Measurements: Tensile strength, ultimate elongations, overall length, width, palm thickness, finger thickness, residual powder, and water leak test. These are directly measurable properties.
- Standardized Biological Tests: Primary skin irritation and dermal sensitization. These produce objective results (e.g., "not an irritant," "not a sensitizer") based on established protocols.
- Conformance to Standards: The "ground truth" is implicitly defined by the requirements outlined in the referenced ASTM standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151-06) and the FDA 1000 ml. Water Fill Test.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI development. It is a manufactured physical product.
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.