(159 days)
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC 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. Poly (viny) chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
Here's a summary of the acceptance criteria and the study details for the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, based on the provided 510(k) summary:
This device is a Class I medical device (K131828), which typically requires less rigorous clinical testing compared to Class II or III devices. The submission focuses on demonstrating substantial equivalence to a predicate device (K110972) through non-clinical performance testing.
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Standard / Acceptance Criteria | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06(Reapproved 2011) | Meets |
| Physical Properties | ASTM standard D 5250-06(Reapproved 2011) | Meets |
| Freedom from pinholes | 21 CFR 800.20 (and ASTM D5250-06, ASTM D5151-06) | Meets (Holes at Inspection Level 1 AQL 2.5) |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) & D6124-06 (Reapproved 2011) | Meets (230mm min. |
| Width | ASTM D5250-06 (Reapproved 2011) (Ranges for S, M, L, XL) | Small 80-85 mm, Medium 95-97 mm, Large 102-108mm, X large 114-118 mm |
| Thickness (Minimum) | ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min., Palm 0.08mm min. | Finger 0.09-0.12 mm, Palm 0.09-0.12 mm |
| Physical Properties (Elongation) | ASTM D5250-06 (Reapproved 2011) ≥300% (before/after aging) | 330-420% (before/after aging) |
| Physical Properties (Tensile Strength) | ASTM D5250-06 (Reapproved 2011) ≥ 14MPa (before/after aging) | 15-18 MPa (before/after aging) |
| Materials Used | Identified as a polymer or other material | PVC |
| Dusting/Donning Powder | Composition identified | PU (Surface Coating Agent) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., pinhole, tensile strength, biocompatibility). It references adherence to ASTM and ISO standards, which would dictate the required sample sizes for those tests.
The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. It implies the performance data was generated through laboratory testing based on the cited standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device's performance is evaluated against established engineering and biocompatibility standards (ASTM, ISO, CFR), not through expert interpretation of medical images or conditions. The "ground truth" for glove performance relies on objective measurements against these standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance is based on objective measurements against established standards, not on expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not relevant for this type of device. The evaluation of patient examination gloves focuses on their physical properties, barrier integrity, and biocompatibility, not on the interpretative performance of human readers aided by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for evaluating this device's performance is based on established industry standards and regulatory requirements:
- ASTM D5250-06 (Reapproved 2011): Standard for Poly(vinyl chloride) Gloves for Medical Application.
- ASTM D5151-06 (Reapproved 2011): Standard for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: Code of Federal Regulations pertaining to barrier integrity.
- ISO 10993-10:2002/Amd.1:2006: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve machine learning algorithms that require 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.