(220 days)
A patient examination glove 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 Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578:05-2010
The provided text describes the acceptance criteria and the performance of an A1 Brand Powder Free Patient Examination Glove. This document is a 510(k) summary for a medical device (patient examination glove), which is often supported by non-clinical performance data rather than extensive clinical studies as seen with AI/software as a medical device (SaMD). Therefore, many of the requested points, particularly those related to AI algorithm performance, ground truth establishment, expert adjudication, and multi-reader multi-case studies, are not applicable to this type of device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| CHARACTERISTICS | STANDARDS | SPECIFICATION (Acceptance Criteria) | DEVICE PERFORMANCE/ACTUAL SPECIFICATION (Reported Performance) |
|---|---|---|---|
| Dimensions | ASTM D3578:05-2010 | Thickness Palm: min 0.08mm Finger: min 0.08mm | Meet. Palm Thickness: 0.09 mm Finger Thickness: 0.11 mm |
| Length (by size) S: min 220 M: min 220 L: min 230 | Length (by size) S: 240 mm M: 240 mm L: 240 mm | ||
| Physical Properties | ASTM D3578:05-2010 | ||
| ASTM D412:06 | |||
| ASTM D573:04-2010 | Tensile Strength (MPa) Before aging: Min 18 MPa After aging: Min 14 MPa | Meet. | |
| Tensile Strength (MPa) Before aging: 22.91 MPa After Aging: 20.98 MPa | |||
| Elongation at Break (%) Before aging: Min 650mm After aging: Min 500mm | Elongation at Break (%) Before aging: 850 mm After aging: 820 mm | ||
| Freedom from pin-holes | ASTM D5151:06-2011 | AQL 1.5 | Meet |
| Powder Free Residue | ASTM D6124:06-2011 | Below 2mg/glove | Meet |
| Protein Content | ASTM D5712:10-2010 | Below 50ug/dm² | Meet |
| Biocompatibility | Animal Irritation Test (ISO 10993-10:2010) | Under the conditions tested, the subject glove was not an irritant. | Under the conditions tested, the subject glove was not an irritant. |
| Dermal Sensitization (ISO 10993-10:2010) | Under the condition tested, the subject glove was not a sensitizer. | Under the condition tested, the subject glove was not a sensitizer. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of gloves tested for each characteristic) used for the non-clinical tests. It refers to compliance with ASTM and ISO standards, which typically include sampling plans. The data provenance is Malaysia, where A1 Glove Sdn. Bhd. is located. These are non-clinical (laboratory/bench) tests, not retrospective or prospective human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/SaMD and does not use "ground truth" derived from expert consensus on medical images or diagnoses. The "ground truth" for glove performance is defined by the objective measurements and chemical analyses specified by the ASTM and ISO standards.
4. Adjudication method for the test set
Not applicable. There is no adjudication method described as this is not a study involving human interpretation or subjective assessment of medical data. 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 device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established international standards and objective laboratory measurements (e.g., precise measurements of thickness, tensile strength, chemical residue, and biological reactivity according to ASTM and ISO protocols). There is no pathology, outcomes data, or expert consensus used in the typical sense for medical imaging or diagnostic algorithms.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
§ 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.