(108 days)
A 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.
Latex Examination Gloves, Powdered
Here's a breakdown of the requested information based on the provided FDA 510(k) clearance letter for "Latex Examination Gloves, Powdered":
Important Note: The provided document is an FDA clearance letter, which means the device has already gone through the review process. This letter approves the device based on a previous submission that contained the details of the studies and acceptance criteria. Therefore, the letter itself does not explicitly list the acceptance criteria or the full study details, but rather confirms that the device has met the requirements for substantial equivalence.
To fully answer your request, one would typically need to refer to the original 510(k) submission (K974660). However, based on the nature of this particular device (Latex Examination Gloves), we can infer common acceptance criteria and the type of studies usually conducted for such products.
Inferred Acceptance Criteria and Reported Device Performance (based on common standards for examination gloves):
| Acceptance Criteria (Inferred) | Reported Device Performance (Implied by Clearance) |
|---|---|
| Physical Properties | |
| Tensile Strength (before and after accelerated aging) | Meets relevant ASTM/ISO standards |
| Elongation at Break (before and after accelerated aging) | Meets relevant ASTM/ISO standards |
| Force at Break (before and after accelerated aging) | Meets relevant ASTM/ISO standards |
| Barrier Integrity | |
| Freedom from Holes (AQL Level 2.5 or 4.0 for water leak test) | Meets an Acceptable Quality Limit (AQL) |
| Biocompatibility | |
| Dermal Sensitization | No significant irritation or sensitization observed |
| Primary Skin Irritation | No significant irritation observed |
| Cytotoxicity | Non-cytotoxic |
| Sterility (if applicable - though this is "examination" gloves, often non-sterile by default) | (Not applicable for non-sterile gloves) |
| Powder Content (for powdered gloves) | Meets relevant ASTM/ISO standards for powder residue |
Explanation:
For medical examination gloves, the primary performance characteristics revolve around their physical strength, barrier integrity (preventing fluid/pathogen transfer), and biocompatibility (not causing adverse reactions on the skin). The FDA's 510(k) clearance implies that the device has demonstrated substantial equivalence to a predicate device, which inherently means it has met these types of performance standards.
1. A table of acceptance criteria and the reported device performance:
See table above. The "reported device performance" is implied by the FDA's "substantial equivalence" finding. The actual numbers would be in the original K974660 submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the clearance letter. For barrier integrity (Freedom from Holes), AQL (Acceptable Quality Limit) sampling plans are typically used (e.g., ANSI/ASQ Z1.4 for attributes sampling), which dictate sample sizes based on lot size and desired AQL level. For physical properties, standard test methods (e.g., ASTM D412) specify sample numbers (e.g., 5-10 specimens per test). Biocompatibility tests usually involve a small number of animal subjects (e.g., 3-5 for irritation/sensitization).
- Data Provenance: Not specified in the clearance letter. Typically, device manufacturers conduct these tests in their own labs or through accredited contract testing organizations. The country of origin of the data would likely be Malaysia (where Ideal Quality Sdn. Bhd. is located) or another country with accredited testing facilities.
- Retrospective or Prospective: These types of performance and safety tests are prospective studies performed specifically to demonstrate compliance with standards for the 510(k) submission.
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):
This question is more applicable to diagnostic devices involving image interpretation or complex clinical assessments. For a physical device like examination gloves:
- Ground Truth Establishment: The "ground truth" for gloves is established by objective, standardized test methods designed to measure physical properties (e.g., ISO, ASTM standards). There isn't an "expert" consensus in the same way as in diagnostic AI.
- Experts involved: The "experts" would be the laboratory personnel performing the standardized tests, who are qualified and trained in operating the testing equipment and interpreting results according to the specified standards (e.g., trained technicians, chemists, materials scientists). Their qualifications would include proficiency in the specific ASTM or ISO test methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable in the sense of expert consensus for diagnostic tasks. The results of the physical and chemical tests are objective measurements. Any "adjudication" would refer to internal lab quality control processes, where results might be cross-checked or equipment calibrated.
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:
- MRMC Study: Not applicable. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). Examination gloves are physical barrier devices, not diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This concept applies to AI algorithms. Examination gloves do not have an "algorithm" component. Their "performance" is inherently standalone in the sense that their physical characteristics are tested directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For examination gloves, the "ground truth" is derived from:
- Standardized Test Methods: Adherence to established international and national standards (e.g., ASTM D3578 for medical examination gloves, ISO 11193 for single-use medical examination gloves) which define acceptable limits for tensile strength, elongation, freedom from holes, etc.
- Reference Materials/Controls: Use of calibrated equipment and reference materials to ensure accurate measurements.
- Chemical Analysis: For biocompatibility and powder content.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This concept applies to machine learning models that require a 'training set' to learn patterns. Examination gloves are manufactured physical products and do not involve a training set in this context. Their design and manufacturing processes are based on engineering principles and material science, not AI training.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for physical medical devices like examination gloves. The "ground truth" for ensuring quality and safety in manufacturing is established through adherence to Good Manufacturing Practices (GMP) and ongoing quality control testing against established product specifications.
§ 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.