(227 days)
The device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the user as protection against possible contamination when examining a patient.
Powderfree Chloroprene Flavored and Colored Patient Examination Gloves
The provided text is a 510(k) premarket notification approval letter for "Powder-Free Colored (White, Pink, Blue Green) and Flavored (Strawberry, Tutti-Fruity and Peppermint) Chloroprene Patient Examination Glove." This document is related to the regulatory approval of a medical device, specifically a patient examination glove.
Medical gloves are designed to prevent contamination and act as a barrier. Their performance is primarily evaluated based on their physical integrity (e.g., freedom from holes) and barrier properties. The provided document does not contain specific acceptance criteria for device performance or the details of a study proving those criteria are met.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are considered comparable. For devices like gloves, "performance" typically refers to physical properties that ensure their barrier function.
However, based on general knowledge of glove regulatory requirements and what would be typical for a 510(k) submission for such a device, I can infer the types of acceptance criteria and studies that would likely have been submitted.
Inferred Acceptance Criteria and Study (Based on common glove standards and 510(k) requirements):
1. Table of Acceptance Criteria and Reported Device Performance (Inferred):
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Example) | Reported Device Performance (Example - Hypothetical) |
|---|---|---|---|
| Physical Integrity | AQL for Pinholes (e.g., per ASTM D5151 or EN 455-1) | AQL 2.5% or 4.0% (depending on specific standard and glove type, e.g., examination vs. surgical) | Tested at AQL 2.5% with 0.9% detected pinholes |
| Physical Properties | Tensile Strength (e.g., per ASTM D412 or EN 455-2) | Before aging: ≥ 18 MPa; After aging: ≥ 16 MPa (for chloroprene) | Before aging: 23 MPa; After aging: 20 MPa |
| Elongation at Break (e.g., per ASTM D412 or EN 455-2) | Before aging: ≥ 650%; After aging: ≥ 500% (for chloroprene) | Before aging: 720%; After aging: 610% | |
| Biocompatibility | Dermal Sensitization (e.g., per ISO 10993-10) | No or negligible sensitization potential (primary dermal irritation, allergic contact dermatitis) | Passed (no sensitization observed in guinea pig maximization test or human patch test) |
| Cytotoxicity (e.g., per ISO 10993-5) | Non-cytotoxic | Passed (no cytotoxic effect observed in MEM elution test) | |
| Chemical Residues | Powder Residue (for powder-free gloves, per ASTM D6124) | ≤ 2 mg/glove | 1.2 mg/glove |
| Protein Content (for latex, but chloroprene is synthetic) | N/A (chloroprene is synthetic, so protein allergy is not a concern) | N/A | |
| Dimensions | Length, Palm Width, Thickness (e.g., per ASTM D3578 or EN 455-2) | Within specified ranges for each size | All sizes met specified dimensions |
2. Sample Size Used for the Test Set and Data Provenance (Inferred):
- Sample Size: For AQL testing (e.g., pinholes), sample sizes are typically determined by statistical sampling plans, often involving hundreds or thousands of gloves from specific production lots. For physical property tests, smaller but statistically significant sample sizes (e.g., 5-10 gloves per lot) are common. Biocompatibility studies use animal models (e.g., 5-10 animals per test group) or in vitro cell cultures.
- Data Provenance: Likely retrospective (tests performed on manufactured lots) and conducted by the manufacturer (PT Irama Dinamika Latex in Indonesia) or a contracted testing laboratory. The document explicitly states the manufacturer is from Indonesia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts (Inferred):
- For physical and chemical tests of gloves, "ground truth" is typically established by standardized laboratory testing procedures performed by certified technicians or engineers in quality control or R&D departments. There isn't typically an "expert consensus" for these types of objective measurements in the same way there would be for image interpretation in radiology. The "experts" are the personnel competent in performing the specified ASTM or EN standard test methods. Their qualifications include training and experience in metrology, materials science, or chemical analysis, often with documented proficiency in the specific test standards.
4. Adjudication Method for the Test Set (Inferred):
- For objective physical, chemical, and biological tests, adjudication is not typically required in the sense of multiple reviewers resolving discrepancies in subjective interpretations. Instead, results are obtained by following a clearly defined standard. If a result is borderline or unexpected, the test may be repeated by the same or different qualified personnel following the same standard, and statistical methods (e.g., for AQL) would determine acceptance or rejection of a lot.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done (Not Applicable):
- No, an MRMC study would not have been done for a patient examination glove. MRMC studies are used for diagnostic devices (e.g., imaging software) to compare the performance of human readers with and without AI assistance on complex cases. A glove is a physical barrier device, not a diagnostic tool requiring human interpretation of information.
6. If a Standalone Study (Algorithm Only) was Done (Not Applicable):
- No, a "standalone" study is not applicable for this device. This refers to the performance of an AI algorithm without human input. A glove is a physical product; there is no embedded algorithm.
7. The Type of Ground Truth Used (Inferred):
- Objective Measurement Data based on Recognized Standards:
- For physical integrity (pinholes): Determined by water leak test or air inflation test as per ASTM D5151 or EN 455-1.
- For physical properties (tensile strength, elongation): Determined by mechanical testing equipment as per ASTM D412 or EN 455-2.
- For biocompatibility: Determined by in vitro (cytotoxicity) and in vivo (sensitization) tests following ISO 10993 series.
- For chemical residues: Determined by gravimetric or analytical chemistry methods (e.g., for powder residue via ASTM D6124).
8. The Sample Size for the Training Set (Not Applicable):
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established (Not Applicable):
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
Summary of Device and Approval:
The provided document details the FDA's approval of "Powder-Free Colored and Flavored Chloroprene Patient Examination Gloves" for marketing based on their substantial equivalence to predicate devices. This means that the device is considered safe and effective because it performs at least as well as other legally marketed gloves, likely demonstrated through a battery of standard physical, chemical, and biological tests. However, the specific test results and acceptance criteria are not included in this regulatory letter itself, but would have been part of the manufacturer's 510(k) submission.
§ 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.