(294 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 Dermagrip powder free blue nitrile patient examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the qloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
This document is a 510(k) summary for the Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile. It provides information about the device's characteristics and how it meets acceptance criteria, primarily through comparison to established standards and a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS | Acceptance Criteria (from Standards) | Reported Device Performance (Current) |
|---|---|---|---|
| Dimensions | ASTM D6319-10 | Meets ASTM D6319-10 requirements | Meets |
| Physical Properties | ASTM D6319-10 | Meets ASTM D6319-10 requirements | Meets |
| Thickness | ASTM D6319-10 | Meets ASTM D6319-10 requirements | Meets (Note: Current device is thinner than predicate but still meets standard) |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | Meets (≤ 2 mg/glove) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Passes (Not a primary skin irritant) | Passes (Not a primary skin irritant). There was no erythema or oedema noted on test sites after (24±2), (48±2) and (72±2) hours. The Primary Irritation Index (PII) was "0". |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4) | Passes (Not a contact sensitizer) | Passes (Not a contact sensitizer). There was no positive allergic reaction observed during the challenge phase at (0±2), (24±2) and (48±2) hours in animals treated with the test material and negative control. |
| Watertight (1000ml) | ASTM D5151-06 | Passes (as per standard) | Passes |
| Intended use | N/A (Descriptive) | Disposable device for medical purposes to prevent contamination between patient and examiner. | 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. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | N/A (Descriptive) | Blue | Blue |
| Texture | N/A (Descriptive) | Finger textured | Finger textured |
| Size | Medical Glove Guidance Manual - Labeling | Small, Medium, Large, Extra Large (for predicate) | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use | Single use |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., for biocompatibility, watertightness, etc.). It only indicates that the device's performance "Meets" the respective standards. The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective, beyond acknowledging that the manufacturer (WRP Asia Pacific Sdn Bhd) is located in Malaysia.
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 type of information is not applicable to the device described. The device is a patient examination glove, and its performance is assessed against established engineering and biocompatibility standards (ASTM, ISO), not through expert interpretation of medical images or clinical outcomes that require "ground truth" established by medical experts in a diagnostic context. The "ground truth" here is the pass/fail criteria defined by the standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As explained above, the assessment is against predefined technical and biological standards, not through adjudication of expert opinions on a test set.
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 device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and effects on human readers are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical product (a glove), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. For example:
- Dimensions, Physical Properties, Thickness: Defined by ASTM D6319-10.
- Powder Free: Defined by ASTM D6124-06 (≤ 2 mg/glove).
- Biocompatibility: Defined by ISO 10993-10:2010(E) and Consumer Product Safety Commission regulations (absence of primary skin irritation, absence of dermal sensitization).
- Watertight: Defined by ASTM D5151-06 (passing the water leak test).
- Intended Use, Material, Color, Texture, Size, Single Use: Compliance with descriptive criteria or labeling guidance.
These standards provide objective, measurable criteria for the device's performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development and testing follow established engineering and manufacturing quality control processes.
9. How the ground truth for the training set was established
Not applicable, as no training set is used for this type of 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.