(106 days)
Powder-Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Powder-Free Yellow Vinyl Patient Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Feature & Description | Acceptance Criteria (Predicate Device / Standard) | Reported Device Performance (Subject Device) | Compliance / Result of Comparison |
|---|---|---|---|
| Product Name | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | Powder-Free Yellow Vinyl Patient Examination Gloves | Same |
| Product Code | LYZ | LYZ | Same |
| Size | Small/Medium/Large/X large | Small/Medium/Large/X large | Substantially equivalent |
| Intended Use | Disposable device for medical purposes, worn on hand/finger to prevent contamination. | Disposable device for medical purposes, worn on hand/finger to prevent contamination. | Substantially equivalent |
| Conformance to Standard | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Dimensions - Length | ≥230mm min. (per ASTM D5250-06) | ≥230mm min. for all sizes (per ASTM D5250-06) | Substantially equivalent |
| Dimensions - Width | Small 80-90 mm, Medium 90-100mm, Large 100-110mm, X large 110-120 mm (per ASTM D5250-06) | Small 83-87 mm, Medium 94-97 mm, Large 103-107mm, X large 113-116 mm (per ASTM D5250-06) | Substantially equivalent |
| Dimensions - Thickness | Finger 0.05mm min., Palm 0.08mm min. (per ASTM D5250-06) | Finger 0.05mm min., Palm 0.08mm min. (per ASTM D5250-06) | Substantially equivalent |
| Physical Properties (Before/After Aging) | Elongation ≥300%, Tensile Strength ≥11MPa (per ASTM D5250-06) | Elongation ≥300%, Tensile Strength ≥11MPa (per ASTM D5250-06) | Substantially equivalent |
| Freedom from Pinholes | Meets: 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (AQL 2.5) | Meets ASTM D5151-06 (AQL 2.5) | Substantially equivalent |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (per ASTM D6124-06) | Substantially equivalent |
| Materials Used | PVC | PVC | Substantially equivalent |
| Dusting or Donning Powder | PU | PU | Substantially equivalent |
| Dusting or Donning Powder Name | PU | Surface Coating Agent | Substantially equivalent |
| Performance Data | Meets ASTM D5151-06, ASTM D5250-06, ASTM D6124-06 | Meets ASTM D5151-06, ASTM D5250-06, ASTM D6124-06 | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
| Biocompatibility | Non-irritant and non-sensitizer per ISO 10993-10:2002/Amd.1:2006 (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES) | Non-irritant and non-sensitizer per ISO 10993-10 Third Edition 2010-08-01 (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES) | Substantially equivalent |
| Labeling | Powder Free, Yellow, Patient Examination Glove, Non sterile, Single Use Only, Manufactured For, Lot | Powder Free, Yellow, Patient Examination Glove, Non sterile, Single Use Only, Manufactured For, Lot | Substantially equivalent |
Study Information:
The study proving the device meets the acceptance criteria is a nonclinical study focused on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for testing each specific characteristic (e.g., number of gloves tested for length, width, tensile strength, pinholes, residual powder, or biocompatibility).
- The data provenance is China (Zibo Litong Plastic Products Co., Ltd. is located in Zibo, Shandong, China).
- The study is retrospective in the sense that it relies on product testing to demonstrate conformance to existing standards and comparison to a legally marketed predicate device, rather than a new prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth for the test set. The "ground truth" here is defined by established performance standards (ASTM standards, 21 CFR regulations, ISO standards) and comparison to a predicate device. The testing would have been conducted by trained personnel in a laboratory setting.
4. Adjudication method for the test set:
- The document does not describe an adjudication method in the context of expert review for the test set. The assessment appears to be based on direct measurement and laboratory testing against pre-defined quantitative and qualitative standards.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices involving human interpretation. This device is a patient examination glove, and the regulatory pathway does not require or involve such studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a physical medical device (glove), not a software or AI algorithm.
7. The type of ground truth used:
- The ground truth used is primarily based on established industry standards and regulatory requirements, including:
- ASTM D5250-06 (Reaffirmation 2011) - for physical properties, dimensions, etc.
- ASTM D5151-06 (Reapproved 2011) - for freedom from pinholes (water leak test).
- ASTM D6124-06 (Reaffirmation 2011) - for residual powder.
- 21 CFR 800.20 - for freedom from pinholes.
- ISO 10993-10 (2002/Amd.1:2006 and Third Edition 2010-08-01) - for biocompatibility (skin irritation and sensitization).
- The characteristics of a legally marketed predicate device (Hebei Leader Plastic Co., Ltd. K122920) serve as a comparative ground truth for demonstrating substantial equivalence.
8. The sample size for the training set:
- Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, no ground truth was established for it.
§ 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.