(135 days)
A powder-free patient examination gloves 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.
Nitrile Examination gloves powder free blue colour as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, blue colour and powder free.
The provided text describes the 510(k) summary for "RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)". This document is for a medical device (nitrile examination gloves), a Class I device. As such, the concept of a "study" to prove performance in the way it might apply to more complex AI/ML or diagnostic devices (e.g., MRMC, standalone algorithm performance, training/test sets, expert adjudication, effect size) is not relevant here.
The document demonstrates substantial equivalence by showing that the device meets established consensus standards for medical gloves.
Here's a breakdown of the requested information based on the provided text, focusing on how it applies to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimension | ASTM D 6319-00a | Meets |
| Physical Properties | ASTM D 6319-00a | Meets |
| Freedom from pinholes | ASTM D 6319-00a | Meets |
| Powder-Free | ASTM D 6319-00a | Meets |
| Biocompatibility | Primary Skin Irritation Test (Consumer Product Safety Commission, Title 16, Chapter II, Part 1500) | Passes |
| Dermal Sensitization Assay (ASTM-F 720-81 (Reapproved 2007)El) | Passes |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample size for each test (e.g., how many gloves were tested for pinholes, or how many subjects for biocompatibility). However, the tests are conducted in accordance with the methodologies outlined in the referenced ASTM and CPSC standards, which would define appropriate sample sizes for such physical and biocompatibility testing.
- Data Provenance: Not explicitly stated as "country of origin for data", but the testing was conducted by the manufacturer (Riverstone Resources Sdn. Bhd.) in Malaysia, as indicated by their address. The testing is assumed to be prospective, as it's part of the premarket notification process for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable to the evaluation of medical gloves. The "ground truth" here is the pass/fail criteria defined by the internationally recognized consensus standards (ASTM, CPSC). There isn't a need for expert radiologists or similar specialists to establish ground truth for glove performance. The "experts" are the technical committees that developed the standards and the technicians who perform the tests according to those standards.
4. Adjudication method for the test set
- This concept is not applicable. Adjudication usually refers to resolving disagreements among multiple human readers. For glove testing, the results are typically objective measurements against a defined standard. There is no ambiguous interpretation requiring 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
- This is not applicable. This is a physical medical device (gloves), not an AI/ML diagnostic tool. There are no "human readers" or "AI assistance" involved in its primary function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. This device is a physical product, not an algorithm or software. No standalone algorithm performance was assessed.
7. The type of ground truth used
- For this device, the "ground truth" is established by consensus standards and regulatory requirements. Specifically:
- ASTM D 6319-00a: This is the standard specification for Nitrile Examination Gloves, defining physical properties, dimensions, and freedom from pinholes.
- Consumer Product Safety Commission (CPSC), Title 16, Chapter II, Part 1500: This covers the Primary Skin Irritation Test.
- ASTM-F 720-81 (Reapproved 2007)El: This pertains to the Dermal Sensitization Assay.
- These standards provide objective, measurable criteria that the device must meet.
8. The sample size for the training set
- This is not applicable. "Training set" refers to data used to train AI/ML models. This device is a physical product, not an AI/ML system.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as point 8.
§ 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.