(76 days)
Black Colour Powder Free Nitrile Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Black Colour Powder Free Nitrile Rubber Examination Glove as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are black in colour and are powder free.
This document describes the acceptance criteria and the study that proves the device meets those criteria for the Black Colour Powder-Free Nitrile Rubber Examination Glove (K034052).
The device is a patient examination glove and is subjected to performance and biocompatibility testing against relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Black Colour Powder-Free Nitrile Rubber Examination Glove are based on ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves. The device's performance is reported to meet all these current specifications.
| Acceptance Criterion (from ASTM D 6319-00a) | Reported Device Performance |
|---|---|
| Physical Properties | Meets all specifications |
| (Specific physical properties like tensile strength, elongation, force at break are implied by meeting the standard, though not detailed in the summary.) | |
| Acceptable Quality Limit (AQL) for Defects | |
| (Specific AQLs for critical, major, and minor defects are implied by meeting the standard, though not detailed in the summary.) | Meets all specifications |
| Biocompatibility | |
| Primary skin irritation | No irritation |
| Delayed contact sensitization | No sensitization |
| Powder Content (for powder-free) | Negative for starch (using USP iodine test) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each test. However, it mentions "Testing performed per ASTM D 6319 - 00a" and "21 CFR 800.20", indicating that typical sample sizes and methodologies prescribed by these standards would have been followed.
The data provenance is from non-clinical tests conducted by the manufacturer, Latexx Manufacturing Sdn. Bhd., located in Malaysia. The testing described is retrospective in the sense that it was performed on finished product samples to demonstrate compliance with standards for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the "ground truth" for this device is established by objective, standardized physical, chemical, and biological tests, not by expert interpretation of data like in medical imaging. The expertise lies in conducting the tests according to the specified ASTM and FDA guidelines and interpreting the quantitative results.
4. Adjudication Method for the Test Set
This is not applicable to this type of device and testing. The evaluation is based on objective measurements and compliance with numerical and qualitative thresholds defined by the standards (ASTM D 6319-00a and 21 CFR 800.20 for biocompatibility). There is no "adjudication" in the sense of reconciling differing expert opinions.
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
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of complex data, often aided by AI. Patient examination gloves are a Class I medical device and do not involve AI or human interpretation in their intended use.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study as described is not applicable. This device is a physical product (examination glove), not an algorithm or software. Its performance is evaluated through physical, chemical, and biological testing, not through algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Established standards and specifications: Primarily ASTM D 6319-00a for physical properties and defect levels.
- Objective laboratory test results: For biocompatibility (primary skin irritation and sensitization) and powder content (USP iodine test).
- Regulatory compliance: Specifically, 21 CFR 800.20 for biological evaluation.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI or machine learning model, so there is no "training set" in the context of data-driven systems. The term "training set" is usually reserved for machine learning algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question is not applicable.
§ 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.