(304 days)
Powder-Free Vinyl Patient Examination Gloves,Clear(non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and exeminer.
Powder-Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
This document describes an application for a 510(k) premarket notification for "Powder-Free Vinyl Patient Examination Gloves, Clear (non-colored)". The application seeks to demonstrate substantial equivalence to a predicate device.
Analysis based on the provided document:
The provided document is a 510(k) summary for medical gloves, not an AI/ML medical device. Therefore, many of the requested criteria related to AI/ML device performance evaluation (such as MRMC studies, training set details, ground truth for AI, etc.) are not applicable to this document. This document focuses on demonstrating the physical and chemical properties of the gloves meet established standards and are equivalent to an already marketed device.
Here's an attempt to address the applicable parts of your request based on the provided text, and explicitly state when a criterion is not applicable:
Device: Powder-Free Vinyl Patient Examination Gloves, Clear (non-colored)
Device Type: Patient Examination Glove (Class I)
Regulatory Submission: 510(k) Premarket Notification (K130732)
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on meeting the requirements of the ASTM D5250-06 (Reaffirmation 2011) standard for vinyl patient examination gloves, along with ASTM D5151-06 (Reaffirmation 2011) for freedom from pinholes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder. Biocompatibility testing (Skin Irritation and Sensitization) followed ISO 10993-10:2002/Amd.1:2006.
Here's a table summarizing the acceptance criteria and the reported device performance as stated in the "Technological Characteristics" table:
| Feature & Description | Acceptance Criteria (from ASTM/ISO standards or stated minimums) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Dimensions - Length | ≥230mm min (per ASTM D5250-06) | 230mm min for all sizes | Substantially Equivalent |
| Dimensions - Width | ASTM D5250-06 specified ranges: Small 80-90mm, Medium 90-100mm, Large 100-110mm, X-Large 110-120mm | Small 80-85mm, Medium 95-97mm, Large 102-108mm, X-Large 114-118mm | Substantially Equivalent |
| Dimensions - Thickness | Finger 0.05mm min (per ASTM D5250-06), Palm 0.08mm min (per ASTM D5250-06) | Finger 0.05mm min, Palm 0.08mm min | Substantially Equivalent |
| Physical Properties (Before/After Aging) | Elongation ≥300%, Tensile Strength ≥14MPa (per ASTM D5250-06) | Elongation ≥300%, Tensile Strength ≥14MPa | Substantially Equivalent |
| Freedom from Pinholes | Meets ASTM D5151-06 (Reaffirmation 2011) and 21 CFR 800.20 (AQL 2.5 for Holes) | Meets ASTM D5151-06 (Reaffirmation 2011), Inspection Level I, AQL 2.5 | Substantially Equivalent |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder | Substantially Equivalent |
| Biocompatibility | Meets ISO 10993-10:2002/Amd.1:2006 for Skin Irritation and Sensitization | The test article was a non-irritant or non-sensitizer | Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each physical/chemical test (e.g., how many gloves were tested for length, width, thickness, pinholes, tensile strength, or residual powder). It only states that the device "meets" the ASTM standards, which inherently define sampling plans for these tests (e.g., AQL levels for pinholes).
- Data Provenance: The testing was presumably conducted by the manufacturer, Aide Plastic Co., Ltd. (China), or a contract lab. The data provenance is associated with the manufacturing process of the subject device. It is not "retrospective" or "prospective" in the sense of clinical trial data, but rather typical quality control and product performance testing.
- Country of Origin: The manufacturer is Aide Plastic Co., Ltd. in Shijiazhuang, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a medical device (glove) performance study based on established engineering and materials standards (ASTM, ISO), not an AI/ML model requiring expert annotation for ground truth. The "ground truth" here is the objective measurement against the specified standard.
4. Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, this is not an AI/ML study requiring adjudication of expert interpretations. The measurements are objective and standard-driven.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically performed for diagnostic imaging AI/ML devices to assess their impact on human reader performance. It is not relevant for patient examination gloves.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is a physical product (glove), not an algorithm. Its performance is evaluated through physical and chemical testing.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is defined by established engineering and materials standards (ASTM D5250-06, ASTM D5151-06, ASTM D6124-06) and biocompatibility standards (ISO 10993-10:2002/Amd.1:2006). These standards define the acceptable ranges and methods for evaluating the device's physical properties.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, no training set or AI model is involved.
Conclusion from the Document (Section b3):
The applicant concludes that the Powder-Free Vinyl Patient Examination Gloves meet the ASTM or equivalent standards and FDA requirements for water leak tests on pinhole AQL, meet labeling claims, and are as safe, as effective, and perform as well as the predicate device (Tangshan Zhonghong Pulin Plastic Co., Ltd. K120968). This conclusion is based on the nonclinical performance data provided. No clinical data was deemed necessary for this device type.
§ 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.