(158 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).
-- 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. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The document describes the acceptance criteria and performance of the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Better Plastic Co., Ltd. against regulatory standards and a predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Feature & Description | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Product Name | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) (K120968) | Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) | Same |
| Product Code | LYZ (K120968) | LYZ | Same |
| Size | Small/ Medium/ Large/X large (K120968) | Small/ Medium/ Large/X large | Substantially Equivalent |
| Intended Use | (K120968) Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner. | Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner. | Substantially Equivalent |
| Device Description & Specs | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250 -06 (Reapproved 2011) | Substantially Equivalent |
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) ≥230mm min. | Meets ASTM D5250-06 (Reapproved 2011) 230mm min for all sizes | Substantially Equivalent |
| Dimensions - 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 95-98 mm, Large 104-107mm, X large 112-116 mm | Substantially Equivalent |
| Dimensions - 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 |
| Physical Properties | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging: Elongation ≥300%, Tensile Strength ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011) Before aging/after aging: Elongation ≥300%, Tensile Strength ≥ 11MPa | Substantially Equivalent |
| 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 |
| Materials | PVC (K120968) | PVC | Substantially Equivalent |
| Dusting or Donning Powder | PU (K120968) | PU / Surface Coating Agent | Substantially Equivalent |
| Performance Data | Meets ASTM D5151-06 (Reapproved 2011), ASTM D5250-06 (Reapproved 2011), ASTM D6124-06 (Reaffirmation 2011) | Meets ASTM D5151-06 (Reapproved 2011), ASTM D5250-06 (Reapproved 2011), ASTM D6124-06 (Reaffirmation 2011) | Substantially Equivalent |
| Single Patient Use | Single Patient Use (K120968) | Single Patient Use | Substantially Equivalent |
| Biocompatibility | Non-irritant and non-sensitizer (studies meets ISO 10993-10:2002/Amd.1:2006) | Not an irritant, not a sensitizer (studies meets ISO 10993-10 Third Edition 2010-08-01) | Substantially Equivalent |
| Labeling | -Powder Free, -devices color: Clear(Non-colored), -Patient Examination Glove, -Non sterile, -Single Use Only, - Manufactured For:, - Lot (K120968) | -Powder Free, -devices color: Clear(Non-colored), -Patient Examination Glove, -Non sterile, -Single Use Only, - Manufactured For:, - Lot | Substantially Equivalent |
Study Details:
The document describes a submission for a 510(k) premarket notification, which is a process to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The study is a comparison of the subject device's performance against established ASTM standards and the predicate device's characteristics rather than a traditional clinical study with patients.
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Sample sizes used for the test set and the data provenance:
- The document does not specify a distinct "test set" in the context of a clinical trial or algorithm evaluation. Instead, the "testing" refers to the manufacturing quality control and performance evaluation of the gloves based on established ASTM standards.
- The data provenance is from non-clinical testing performed by the manufacturer, Better Plastic Co., Ltd. The country of origin for the manufacturing and testing is China, as indicated by the submitter's address. The data is prospective in the sense that it's generated for the submission of this specific device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and submission. "Ground truth" in the context of diagnostic AI or image analysis typically refers to definitively confirmed diagnoses by expert clinicians, pathology, or long-term outcomes. For patient examination gloves, the "truth" is whether they meet specified physical, chemical, and biological performance standards (e.g., tensile strength, freedom from pinholes, biocompatibility). These are evaluated through standardized laboratory tests, not by human expert consensus on a diagnostic outcome.
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Adjudication method for the test set:
- Not applicable. The "adjudication" for this product involves laboratory testing against defined standards. There is no human observer consensus or adjudication required beyond verifying that the test results meet the specified criteria.
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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:
- Not applicable. This is a medical device (patient examination gloves), not an AI diagnostic imaging tool or a system that involves human "readers" or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through physical and chemical testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is defined by adherence to established international and national standards for patient examination gloves, specifically:
- ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Gloves for Medical Application.
- ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: General requirements for medical devices.
- ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
- The testing also focuses on demonstrating substantial equivalence to a legally marketed predicate device (K120968) which presumably met these same standards.
- The "ground truth" for this device's performance is defined by adherence to established international and national standards for patient examination gloves, specifically:
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device. The manufacturing process is controlled, and samples are taken for quality assurance testing against the standards. This is not an AI/ML product that learns from a training dataset.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The performance standards are established by consensus national and international bodies (e.g., ASTM, ISO, FDA regulations) for medical devices of this 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.