(146 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
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.
The provided document is a 510(k) summary for "Powder Free Blue Nitrile Examination Gloves" (K213107) and does not describe an AI medical device. Therefore, many of the requested fields are not applicable. This summary focuses on the safety and performance of physical medical gloves, primarily through non-clinical testing against established standards.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method / Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D 5151 (Pinhole) | Free from holes, AQL 1.5 | Pass |
| ASTM D6319 (Physical) | Before Aging: Tensile Strength: Min 14 MPa, Elongation: Min 500% | Pass |
| After Aging: Tensile Strength: Min 14 MPa, Elongation: Min 400% | Pass | |
| Watertight (1000mL) | Single Sampling in accordance with ISO 2859 G1: AQL 2.5 | Pass G1: AQL 2.5 |
| Length (mm) | Min 220 (S), Min 230 (M, L, XL) | 240mm minimum for all sizes |
| Palm width (mm) | 80 ± 10 (S), 95 ± 10 (M), 110 ± 10 (L), 120 ± 10 (XL) | 84-86 (S), 95-96 (M), 108-109 (L), 114-115 (XL) |
| Thickness (mm) | Min 0.05 (Finger, Palm, Cuff) | Min 0.06 (Finger), Min 0.06 (Palm), Min 0.05 (Cuff) |
| ASTM D412 (Physical) | Before Aging: Tensile Strength: Min 14 MPa, Elongation: Min 500% | 17-23 (Tensile Strength), 540-607 (Elongation) |
| After Aging: Tensile Strength: Min 14 MPa, Elongation: Min 400% | 21-27 (Tensile Strength), 480-565 (Elongation) | |
| ASTM D6124 (Powder) | Max 2.0 mg/glove | Below 2.0 mg/glove |
| Guinea Pig Sensitization | No deviations noted, no positive allergic reaction | No reaction observed, no positive allergic reaction. Meets conformance requirements. |
| Primary Dermal Irritation (Rabbits) | No deviations noted, identify primary irritants | Primary Irritation Index was 0. Meets conformance requirements. |
| Acute Systemic Cytotoxicity (Rats) | No adverse reaction noted | All animals survived, gained weight, no abnormalities in necropsies. Meets conformance requirements. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for pinholes, physical properties, or biocompatibility). However, it refers to standards such as "Single Sampling in accordance with ISO 2859 G1" for the watertight test, which implies a statistically determined sample size based on the Acceptable Quality Level (AQL). The tests appear to be performed on the final and finished devices.
- Data Provenance: Not explicitly stated, but given the applicant's location (Novid PPE Sdn Bhd, Malaysia), the testing was likely conducted in Malaysia or a lab contracted by them. The tests are non-clinical, meaning they involve physical product testing and animal studies, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-AI medical device (examination gloves). Ground truth for these tests is established by adherence to recognized international and national standards (e.g., ASTM, ISO) and laboratory protocols, not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against predefined criteria in established standards, not subjective assessments requiring expert adjudication.
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 medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI medical device.
7. The type of ground truth used
For the performance and physical properties, the "ground truth" is defined by the specified minimum or maximum values and methodologies outlined in the referenced ASTM and ISO standards (e.g., ASTM D6319 for physical properties, ASTM D5151 for pinhole detection, ASTM D6124 for powder content). For biocompatibility, the ground truth is established by the absence of adverse biological reactions using standard animal testing protocols (ISO 10993-10, ISO 10993-11).
8. The sample size for the training set
Not applicable. This is not an AI medical device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI medical device.
§ 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.