(58 days)
Powder Free Nitrile Examination Gloves, Orange is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Orange are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile latex and are powder free. They are ambidextrous. The physical and performance characteristics of the devices meet all requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) summary for the Powder Free Nitrile Examination Gloves, Orange, and it describes a non-clinical study to demonstrate substantial equivalence to a predicate device, not a study to prove the device meets acceptance criteria for a new medical device technology. Therefore, many of the requested elements for a study proving device performance (e.g., sample size for test set, ground truth, MRMC study, training set information) are not applicable or not provided in the context of this regulatory submission.
However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted to support the device's substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests):
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All sizes ≥ 230mm |
| ASTM D6319-19 | Palm Width (XS) | 70 ± 10mm | 76-78mm |
| ASTM D6319-19 | Palm Width (S) | 80 ± 10mm | 86-88mm |
| ASTM D6319-19 | Palm Width (M) | 95 ± 10mm | 96-98mm |
| ASTM D6319-19 | Palm Width (L) | 110 ± 10mm | 106-108mm |
| ASTM D6319-19 | Palm Width (XL) | 120 ± 10mm | 116-118mm |
| ASTM D6319-19 | Palm Width (XXL) | 130 ± 10mm | 126-128mm |
| ASTM D6319-19 | Thickness (Finger) | 0.05mm (min) | 0.15-0.18mm |
| ASTM D6319-19 | Thickness (Palm) | 0.05mm (min) | 0.16-0.22mm |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | 15.8-19.9Mpa |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | 15.2-18.8Mpa |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | 500-550% |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | 430-500% |
| ASTM D5151-19, ASTM D6319-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL 2.5 requirements |
| ASTM D6124-06(2017), ASTM D6319-19 | Powder-Content | ≤ 2 mg per glove | 0.55-0.78 mg |
| ISO 10993-10:2010 | Biocompatibility: Primary Skin Irritation | Not an irritant | Under conditions of the study, not an irritant |
| ISO 10993-10:2010 | Biocompatibility: Dermal Sensitization | Not a sensitizer | Under conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Biocompatibility: Cytotoxicity | Cytotoxicity concern addressed by acute systematic toxicity testing | Test article extract showed potential toxicity to L929 cells, concern addressed by acute systematic toxicity testing |
| ISO 10993-11:2017 | Biocompatibility: Acute Systemic Toxicity | No systemic toxicity | Extracts (polar and non-polar) did not show any systemic toxicity |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes (number of gloves or tests) for each non-clinical test conducted. It only reports the ranges of performance achieved.
- Data Provenance: The data is from non-clinical tests performed by Shanxi Hongjin Plastic Technology Co., Ltd. for their device Powder Free Nitrile Examination Gloves, Orange. The type of data is laboratory test results. No country of origin for the data is explicitly stated beyond the manufacturing company's location in China. The tests are prospective in the sense that they were conducted for this specific device to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. These are non-clinical material and performance tests, not clinical studies requiring expert ground truth for interpretation of medical data. The "ground truth" is defined by the technical specifications and standards (e.g., ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study involving human readers or adjudicators for diagnosis. The tests are objective measurements against defined 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:
- Not applicable. This is not an AI-assisted device, nor a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for these tests is based on established industry standards (ASTM D6319-19, ASTM D412-16, ASTM D5151-19, ASTM D6124-06(2017)) and international biocompatibility standards (ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2017). These standards specify the test methods and the acceptable ranges for the physical, chemical, and biological properties of examination gloves.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. As above, this does not involve a training set for an algorithm.
§ 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.