(100 days)
This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).
Nitrile rubber is impermeable to water and body fluids under normal conditions of use. The physical properties of the nitrile rubber enable it to conform to the hand for medical procedures. Nitrile rubber is known to form a superior barrier to bloodborne pathogens and meet physical properties for medical examination procedures as specified in ASTM D6319-00ae3.
This document is a 510(k) submission for Green Powder-Free Nitrile Examination Gloves, identifying K041276 as the submission number. The submission outlines the device's characteristics, intended use, and a comparison to a predicate device (K030207). It includes performance data from non-clinical tests to demonstrate safety and effectiveness.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance (This Submission) | Reported Device Performance (Predicate K030207) |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-00ae3, ASTM D5151-99, FDA 21 CFR 800.20 | Meets | Meets |
| Powder-Free Residual | ASTM D6124-01 | Meets, Less than 2 mg/glove | Meets, Less than 2 mg/glove |
| Physical Properties | ASTM D6319-00ae3 | Meets | Meets |
| Dimensions | ASTM D6319-00ae3 | Meets | Meets |
| Primary Skin Irritation | ISO 10993 Biological Evaluation of Medical Devices, Part 10 | Passes | Not explicitly stated for predicate in table, but implied by substantial equivalence |
| Dermal Sensitization | Guinea Pig Sensitization, Buehler Method | Passes | Not explicitly stated for predicate in table, but implied by substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the non-clinical tests (e.g., number of gloves tested for freedom from holes or physical properties). Similarly, the country of origin for the data is not specified beyond the submitter's location in Shanghai, China. The studies described are non-clinical (laboratory testing), not human clinical trials, so the terms "retrospective" or "prospective" are not applicable in the typical sense for patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The ground truth for these non-clinical tests is established by adherence to recognized international and national standards (ASTM, FDA, ISO) and the results obtained from standardized testing methods. There is no mention of expert consensus establishing ground truth for these specific performance characteristics.
4. Adjudication Method:
Not applicable. This is not a study involving human readers or interpretations needing adjudication. The results are based on objective measurements and adherence to specified pass/fail criteria within the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved, which is not the case for examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in a sense, the tests performed are "standalone" in that they evaluate the physical and biological properties of the glove itself against established standards, without human interaction in a diagnostic or interpretive loop. The device's performance is determined solely by its material properties and manufacturing quality as measured by the specified tests.
7. The Type of Ground Truth Used:
The ground truth used for these tests is defined by:
- Established Standards: ASTM D6319-00ae3, ASTM D5151-99, ASTM D6124-01, FDA 21 CFR 800.20, and ISO 10993 Part 10. These standards set the criteria for acceptable performance (e.g., maximum allowable holes, maximum powder residue, minimum physical properties like tensile strength).
- Experimental Results: The outcome of the tests (e.g., whether the glove "Meets" the standard, or "Passes" irritation tests) constitutes the evidence against these standards.
8. The Sample Size for the Training Set:
Not applicable. This device is a medical glove, and the evaluation is based on non-clinical performance testing. It does not involve AI algorithms that require training sets of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set for an AI algorithm is involved.
§ 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.