(76 days)
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED for MEDICAL PURPOSES THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER
SATARI® latex patient examination glove, is a powder glove single side polymer coated, non sterile, 50 ug or less of total water extractable protein per gram, 10 mg/dm2 or less of residual powder
The provided 510(k) summary (KO14110) describes a medical device, the SATARI® latex patient examination powdered glove. It claims substantial equivalence to a predicate device, Siam Sempermed Latex Patient Examination Glove Polymer powder-free (K981096). This submission is for an ABBREVIATED 510(k) type, which typically relies on established performance standards and a declaration of conformity, implying the device meets pre-defined criteria rather than requiring extensive new clinical studies.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of numerical acceptance criteria with reported performance values for properties like tensile strength, elongation, or protein content. Instead, it claims "Identical" or "Similar" for various technological characteristics when compared to the predicate device. This is typical for an Abreviated 510(k) where conformity to recognized standards often replaces detailed performance tables.
However, specific claims about the device's characteristics that would need to meet certain standards (and thus act as acceptance criteria) are mentioned:
| Acceptance Criteria (Derived from Device Description/Claims) | Reported Device Performance (Implied by "Identical"/ "Similar" to K981096 and descriptions) |
|---|---|
| Total water extractable protein per gram: ≤ 50 µg | ≤ 50 µg (Stated in device name and description, and implied by substantial equivalence to a predicate that would meet similar protein limits for examination gloves) |
| Residual powder: ≤ 10 mg/dm² | ≤ 10 mg/dm² (Stated in device name and description, and implied by substantial equivalence to a predicate that would meet similar powder limits for examination gloves) |
| Indications for Use: Disposable, for medical purposes, worn on examiner's hand to prevent contamination between patient and examiner | Identical to predicate device (Stated in comparison table) |
| Target population: (Not explicitly defined, but implied for general medical examination use) | Identical to predicate device (Stated in comparison table) |
| Design: (Physical attributes of the glove) | Similar to predicate device (Stated in comparison table) |
| Materials: (Type of latex, polymer coating) | Identical to predicate device (Stated in comparison table) |
| Performance: (e.g., Barrier integrity, physical properties like tensile strength, elongation) | Identical to predicate device (Stated in comparison table, likely referring to compliance with ASTM D3578) |
| Sterility: Non-sterile | Identical (Non-sterile) to predicate device (Stated in comparison table) |
| Biocompatibility: (No adverse reactions) | Identical to predicate device (Stated in comparison table) |
| Mechanical safety: (e.g., tear resistance) | Identical to predicate device (Stated in comparison table) |
| Chemical safety: (e.g., absence of harmful leachables) | Identical to predicate device (Stated in comparison table) |
| Anatomical sites: Hand | Identical to predicate device (Stated in comparison table) |
| Human factors: (Ease of donning/doffing, fit, comfort) | Identical to predicate device (Stated in comparison table) |
| Standards met: (e.g., relevant ASTM standards for medical gloves) | Identical to predicate device (Stated in comparison table, implying compliance with recognized standards) |
The "study that proves the device meets the acceptance criteria" in this context is the declaration of conformity to established standards and the demonstration of substantial equivalence to the predicate device. For an abbreviated 510(k), the detailed test results are typically summarized or declared as meeting specified standards, rather than presenting a full, independent study write-up. The submission references "ADDITIONAL TECHNICAL COMPARATIVE TABLE WITHIN 510K SUBMISSION" which would contain details if this were a traditional submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided text does not specify the sample size used for any testing or the data provenance. For an abbreviated 510(k) for a well-established device like examination gloves, testing would typically involve standard methods (e.g., ASTM D3578 for rubber examination gloves) on representative batches of the manufactured product. The facility location (Thailand) suggests the tests would be performed on gloves manufactured there, but direct data provenance is not stated.
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 information is not applicable and not provided. This device is a physical medical glove, not a diagnostic or AI-driven device requiring expert interpretation for "ground truth" establishment in a diagnostic sense. Performance is assessed through objective physical and chemical tests (e.g., tensile strength, protein content).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for diagnostic accuracy, where multiple experts evaluate cases to reach a consensus on "ground truth." For physical device testing, objective measurement methods are used.
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 information is not applicable and not provided. This device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance would be the objective measurements obtained from standardized physical, chemical, and biological tests (e.g., ASTM standards for mechanical properties like tensile strength and elongation, validated laboratory methods for protein content and barrier integrity). Pathology or outcomes data are not directly relevant for evaluating the intrinsic performance of an examination glove.
8. The sample size for the training set:
This information is not applicable and not provided. This device is not an machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As above, this device is not an 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.