(311 days)
Powder Free Vinyl Patient Examination Gloved) 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). PVC films form a barrier to body fluids and bloodborne Pathogens. 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. 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 provided text describes Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored). This device is classified as a Class I medical device under regulation number 21 CFR 880.6250.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are based on demonstrating substantial equivalence to a predicate device (Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908) by meeting established ASTM standards.
| Feature & Description | Acceptance Criteria (Predicate Device / ASTM Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| General | |||
| Product Code | LYZ | LYZ | Same |
| 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 |
| Device Specifications | |||
| Meets ASTM Standard | ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) | 230mm min for all sizes | Substantially equivalent |
| Dimensions - Width | Meets ASTM D5250-06 (Reapproved 2011) | Small 80-85 mm, Medium 95-97 mm, Large 102-108mm, X large 114-118 mm | Substantially equivalent |
| Dimensions - Thickness | Meets ASTM D5250-06 (Reapproved 2011) | Finger 0.05mm min., Palm 0.08mm min. | Substantially equivalent |
| Physical Properties | |||
| Before aging/after aging | Elongation ≥300%, Tensile Strength ≥14MPa (ASTM D5250-06) | Elongation ≥300%, Tensile Strength ≥14MPa | Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 | Meets ASTM D5151-06 (Inspection Level I, AQL 2.5) | Substantially equivalent |
| Residual Powder | Meets ASTM D6124-06 (Reapproved 2011) | Results generated values below 2mg of residual powder | Substantially equivalent |
| Material/Biocompatibility | |||
| Compare all materials used | PVC | PVC | Substantially equivalent |
| Dusting or Donning Powder | PU | PU (Surface Coating Agent) | Substantially equivalent |
| Biocompatibility | Skin Irritation Dermal and Sensitization Studies (ISO 10993-10:2002/Amd.1:2006) | Non-irritant or non-sensitizer (Skin Irritation Dermal and Sensitization Studies Meets ISO 10993-10:2002/Amd.1:2006) | Substantially equivalent |
| Other | |||
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
| Labeling for the devices | Powder Free, Clear (Non-colored), Patient Examination Glove, Non-sterile, Single Use Only, Mfg. For, Lot | Powder Free, Clear (Non-colored), Patient Examination Glove, Non-sterile, Single Use Only, Mfg. For, Lot | Substantially equivalent |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size or data provenance in the context of typical clinical or AI/algorithm studies. The device is a patient examination glove, and its performance is evaluated against established physical and chemical standards (ASTM, ISO, CFR). The tests performed are likely destructive or involve laboratory analysis of glove samples. The provenance of these samples (e.g., country of origin) is not specified as being relevant beyond the manufacturer's location in China.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The device's performance is assessed against recognized industry standards (ASTM, ISO) and regulatory requirements (21 CFR), not through expert interpretation of medical images or patient data. The "ground truth" is defined by these objective technical specifications and test methods.
4. Adjudication Method
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical data by multiple experts. For this device, the compliance is determined by laboratory testing against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical data, potentially with AI assistance. The described device is a physical barrier (gloves), not a diagnostic tool requiring interpretation.
6. Standalone (Algorithm Only) Performance
No standalone algorithm-only performance was done. The device does not involve an AI algorithm; it is a physical medical device.
7. Type of Ground Truth Used
The ground truth used for this device is based on objective technical standards and regulatory requirements. Specifically, this includes:
- ASTM Standards: ASTM D5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reaffirmation 2011), and ASTM D6124-06 (Reaffirmation 2011). These standards define specific physical properties, dimensions, and performance characteristics (e.g., tensile strength, elongation, freedom from pinholes, residual powder).
- Regulatory Requirements: 21 CFR 800.20 (Freedom from Pinholes).
- International Standards: ISO 10993-10:2002/Amd.1:2006 for biocompatibility (skin irritation and sensitization).
8. Sample Size for the Training Set
This information is not applicable. The device is not an AI/machine learning model, so there is no "training set" in the conventional sense. The manufacturing process of the gloves would involve quality control and statistical process control, which might use samples, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set." The performance of the gloves is established by testing against the aforementioned objective technical standards and regulatory requirements.
§ 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.