(245 days)
Powder Free Yellow Vinyl Patient Examination Gloves 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.
Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions: PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The document describes a 510(k) premarket notification for "Powder-Free Yellow Vinyl Patient Examination Gloves" (K143347). The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, which is also a Powder-Free Vinyl Patient Examination Glove, Yellow Color (K122920).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is evaluated against ASTM standards and FDA requirements. The table below summarizes the key acceptance criteria and the device's reported performance, as it is claimed to meet these standards.
| Acceptance Criteria | Device Performance (K143347) |
|---|---|
| Device Description & Specifications | Meets ASTM D5250-06 (Reapproved 2011) |
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) |
| ≥230mm min. for all sizes | |
| Dimensions - Width | Meets ASTM D5250-06 (Reapproved 2011) |
| Small 83-87 mm, Medium 93-97 mm, Large 103-107mm, X large 111-116 mm | |
| Dimensions - Thickness | Meets ASTM D5250-06 (Reapproved 2011) |
| Finger 0.05mm min., Palm 0.08mm min. | |
| Physical Properties (Before/After Aging) | Meets ASTM D5250-06 (Reapproved 2011) |
| Elongation ≥ 300%, Tensile Strength ≥ 11MPa | |
| Freedom from Pinholes | Meets ASTM D5151-06 (Reapproved 2011) and 21 CFR 800.20 |
| Inspection Level I, AQL 2.5 | |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) |
| Results generated values below 2mg of residual powder | |
| Biocompatibility | Meets ISO 10993-10 Third Edition 2010-08-01 |
| Test article was a non-irritant or non-sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, tensile strength, etc.). However, it indicates compliance with recognized standards that would implicitly define appropriate sampling plans.
- Data Provenance: The testing appears to have been conducted by the manufacturer, Zibo Zhouheng Plastic Products Co. Ltd, in China, to demonstrate compliance with international and US standards. The data is retrospective, as it refers to tests conducted on the manufactured device for submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device submission. The "ground truth" for medical gloves is established by their adherence to defined performance specifications and safety standards (e.g., ASTM, ISO, FDA regulations) as measured through physical and chemical testing, not by expert consensus on clinical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. For glove testing, results are objective measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
This is not applicable. MRMC studies and the concept of AI assistance for human readers are relevant to AI/ML-driven diagnostic devices, not patient examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device is based on established performance standards and regulatory requirements. Specifically:
- ASTM Standards: ASTM D5250-06 (Reaffirmation 2011) for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for freedom from holes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder.
- FDA Regulations: 21 CFR 800.20 for barrier integrity.
- ISO Standard: ISO 10993-10 Third Edition 2010-08-01 for biocompatibility (skin irritation and sensitization).
These standards define the acceptable physical properties, barrier integrity, and biological safety of the gloves.
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical product and does not involve AI/ML. All testing mentioned constitutes part of the validation process against established standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.