(100 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 examiner.
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided document describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" manufactured by Shijiazhuang Aok Plastic Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are primarily based on meeting various ASTM standards and FDA regulations, demonstrating equivalence to the predicate device. The performance of the subject device is stated to meet these same standards and specifications.
| Feature | Acceptance Criteria (Predicate Device / Standard) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| General | |||
| Product Name | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) | Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) | Same |
| Product Code | LYZ | LYZ | Same |
| Intended Use | Disposable device intended for medical purposes, worn on examiner's hand/finger to prevent cross-contamination. | Disposable device intended for medical purposes, worn on examiner's hand/finger to prevent cross-contamination. | Substantially equivalent |
| Physical Properties | |||
| Device Description & Specs | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250 -06 (Reapproved 2011) | Substantially equivalent |
| Length | Meets ASTM D5250-06 (Reapproved 2011), ≥230mm min. | Meets ASTM D5250-06 (Reapproved 2011), 230mm min for all sizes | Substantially equivalent |
| Width | Meets ASTM D5250-06 (Reapproved 2011) | ||
| Small 80-90 mm | |||
| Medium 90-100mm | |||
| Large 100-110mm | |||
| X large 110-120 mm | Meets ASTM D5250-06 (Reapproved 2011) | ||
| Small 85-87 mm | |||
| Medium 93-97 mm | |||
| Large 103-106mm | |||
| X large 113-115 mm | Substantially equivalent | ||
| Thickness | Meets ASTM D5250-06 (Reapproved 2011) | ||
| Finger 0.05mm min. | |||
| Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011) | ||
| Finger 0.05mm min. | |||
| Palm 0.08mm min. | Substantially equivalent | ||
| Elongation (Before/After aging) | Meets ASTM D5250-06 (Reapproved 2011), ≥300% | Meets ASTM D5250-06 (Reapproved 2011), ≥300% | Substantially equivalent |
| Tensile Strength (Before/After aging) | Meets ASTM D5250-06 (Reapproved 2011), ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011), ≥11MPa | Substantially equivalent |
| Performance Characteristics | |||
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) | |
| Holes Inspection Level I, AQL 2.5 | Substantially equivalent | ||
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | ASTM D6124-06 (Reaffirmation 2011) | |
| Results generated values below 2mg of residual powder | Substantially equivalent | ||
| Biocompatibility | Under the conditions of this study, the test article was a non-irritant and non-sensitizer. (Predicate's reported claim) | Under the conditions of this study, the test article was a non-irritant and non-sensitizer. | Substantially equivalent |
| Labeling for Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006 (Predicate's reported standard) | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 Third Edition 2010-08-01 | Substantially equivalent |
| Materials | PVC, PU (as Dusting or Donning Powder) | PVC, PU (as Dusting or Donning Powder / Surface Coating Agent) | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each specific characteristic. However, it references conformity to ASTM and ISO standards (e.g., ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-10). These standards typically define the sampling plans and methodologies for testing.
- Data Provenance: The tests were conducted to demonstrate conformity to international and national standards (ASTM, ISO). The manufacturing company is Shijiazhuang Aok Plastic Co., Ltd. located in China. The testing data would likely be from retrospective tests performed on newly manufactured devices by the applicant or a certified testing laboratory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (patient examination gloves) does not typically involve "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for performance is based on quantifiable measurements against established engineering and material standards. Therefore, information about experts and their qualifications for establishing ground truth is not applicable to this submission.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretation (e.g., medical imaging). For the physical and performance testing of medical gloves, measurements are typically objective and quantitative, and thus no adjudication method as typically understood in medical device AI/diagnostic studies is used. Testing laboratories follow standardized protocols for obtaining measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to evaluate the impact of a device (often AI-based diagnostics) on human reader performance. This submission is for a physical medical device (gloves) with performance criteria based on manufacturing and material standards, not diagnostic interpretation.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is not an algorithm or software-based device. Performance is assessed through physical and chemical testing of the manufactured product.
7. Type of Ground Truth Used
The "ground truth" for this device is based on established engineering and material standards (e.g., ASTM D5250-06 for physical properties, ASTM D5151-06 for pinholes, ASTM D6124-06 for residual powder, and ISO 10993-10 for biocompatibility). These standards define objective pass/fail criteria and test methods.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no training set in the conventional sense. The product is manufactured and tested according to specified quality control processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for a training set. The "ground truth" for ensuring quality manufacturing is embedded within the referenced ASTM and ISO standards for material properties and testing protocols.
§ 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.