(235 days)
Powder Free Nitrile Patient Examination Gloves, Blue 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.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile 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. Nitrile 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 glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The provided document describes the acceptance criteria and the study results for the "Powder Free Nitrile Patient Examination Gloves, Blue Color" (subject device) which is seeking substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Characteristics | Standard (Acceptance Criteria) | Device Performance (Subject Device) |
|---|---|---|
| Dimension | ASTM standard D 6319-10. | |
| Length | ≥230mm | 234-243mm |
| Width (Small) | 70-90 mm | 78-85mm |
| Width (Medium) | 85-105mm | 95-99mm |
| Width (Large) | 100-120mm | 108-113mm |
| Width (X large) | 110-130 mm | 117-126mm |
| Thickness (Fingertip) | ≥0.05mm | 0.08-0.11 mm |
| Thickness (Palm) | ≥0.05mm | 0.08-0.12 mm |
| Physical Properties | ASTM standard D 6319-10. | |
| Tensile strength (Before aging) | ≥14MPa (based on predicate comparison) | 20-23MPa |
| Tensile strength (After aging) | ≥14MPa | 18-21 MPa |
| Elongated rate (Before aging) | ≥500% | 560-600% |
| Elongated rate (After aging) | ≥400% | 530-580% |
| Freedom from pinholes | • 21 CFR 800.20 | |
| • ASTM standard D 6319-10. | ||
| • Test method in accordance with ASTM D5151-06(Reapproved 2011) | Passed Standard Acceptance Criteria (Tested in accordance with ASTM D5151 (Reapproved 2011) with acceptable results) | |
| Powder Residual | ASTM standard D 6319-10. | |
| Test method in accordance with D6124-06 (Reaffirmation 2011) | ||
| below 2mg of residual powder (based on predicate comparison) | 0.1mg/glove (Results generated values below 2mg of residual powder) | |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10: Third Edition 2010-08-01) | Under the conditions of the study, the device was a non-irritant. |
| Dermal sensitization in the guinea pig (ISO 10993-10: Third Edition 2010-08-01) | Under the conditions of the study, the device was a non-sensitizer. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for dimensions, tensile strength, pinholes). However, it implies testing was conducted on samples derived from the "Powder Free Nitrile Patient Examination Gloves, Blue Color."
The data provenance is from China, as the submitter, Suqian Xingye Glove Co,Ltd, is located in Suqian City, Jiangsu Province, China. The studies appear to be prospective as they were conducted to obtain data for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this submission. The "ground truth" for glove performance is established by standardized testing methods (ASTM, CFR, ISO) rather than expert consensus on medical 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 for studies involving human interpretation (e.g., diagnostic image reading) where there might be disagreement among experts. For performance testing of medical gloves, the results are determined by objective measurements against established 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:
This is not applicable. MRMC studies are relevant for AI-powered diagnostic tools or decision support systems. This submission concerns the physical and biological properties of patient examination gloves, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. There is no AI algorithm involved in the performance of patient examination gloves. The device's performance is standalone in the sense that its physical properties are measured directly.
7. The type of ground truth used:
The ground truth used for these studies are:
- Standardized specifications: Primarily ASTM standards (e.g., D6319-10, D5151-06, D6124-06) and FDA regulations (21 CFR 800.20) for physical properties.
- Biological safety standards: ISO 10993-10: Third Edition 2010-08-01 for biocompatibility.
- These standards define the acceptable range or threshold for each characteristic (e.g., minimum length, maximum powder residual, non-irritant/non-sensitizer).
8. The sample size for the training set:
This is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device (gloves) and does not involve AI or machine learning.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for a machine learning model.
§ 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.