(76 days)
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Les Protein is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove and Protein Labeling Claim of 50 Micrograms or Less Protein is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-051, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves And Protein Labeling Claim of 50 Micrograms or Less Protein":
This document describes a 510(k) premarket notification for a medical device (examination gloves). The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the "study" referenced here is largely non-clinical testing to meet established standards.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D 3578-051 requirements | Meets all current requirements |
| 21 CFR 800.20 | Meets requirements |
| Primary skin irritation (rabbit) | No irritation |
| Delayed contact sensitization (guinea pig) | No sensitization |
| USP iodine test for starch presence | Tested negative for starch |
| Protein Labeling Claim (less than 50 micrograms) | Not explicitly stated if tested in this section, but the device name implies it meets this claim. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for ASTM D3578, or how many rabbits/guinea pigs were used).
- Provenance: The manufacturing country is Malaysia (Latexx Manufacturing Sdn. Bhd., PT 5054, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia). The testing described appears to be retrospective as it's a pre-market submission demonstrating compliance with existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert consensus for "ground truth" in the typical sense of a diagnostic or interpretive device. The "ground truth" here is adherence to established engineering and biocompatibility standards, and the results of laboratory tests.
4. Adjudication method for the test set
Not applicable. No expert adjudication method (like 2+1, 3+1) is mentioned or relevant for these types of engineering and biocompatibility tests.
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 a diagnostic device or an AI-enabled device. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was performed. The device is an examination glove.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. It is a physical medical device (gloves).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on:
- Established engineering standards: ASTM D 3578-051 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20 (dealing with powder on surgeon's gloves and examination gloves).
- Biocompatibility testing results: Primary skin irritation and delayed contact sensitization tests.
- Chemical tests: USP Iodine test for starch.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set 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.