(89 days)
The Non-sterile Powder Free Black Nitrile Examination Gloves with Cherry Flavor, 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.
Doves I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00a (2005) Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the acceptance criteria and the study proving the device meets those criteria for Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor.
It's important to note that this is a premarket notification (510(k)) for a Class I medical device (patient examination glove). The "study" here refers to demonstrating compliance with established performance standards and biocompatibility testing, rather than a clinical trial with human subjects in the way one might think of for more complex medical devices or pharmaceuticals.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard/Test | Reported Device Performance (as implied by "meets" or "equivalent") |
|---|---|
| ASTM D6319-00a(2005) | Met: Standard Specification for Nitrile Gloves. |
| ISO 2859-1 (Water Leak Test) | Met: Standard for Water Leak Test. |
| ASTM D5151-06 (Hole Detection) | Met: Test Method for Detection of Holes in Medical Gloves (alternative to ISO 2859-1). |
| ASTM D6124-06 | Met: Standard Test Method for Residual Powder on Medical Gloves. |
| Biocompatibility Testing | Met: Testing performed on White Rabbits and Guinea Pigs. |
| Labeling | Met: FDA Specifications. |
| Equivalence to K072400 | Met: Except for the cherry flavor, this glove is equivalent to the predicate device K072400 (POWDER FREE BLACK NITRILE EXAM GLOVES). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for water leak, number of residual powder tests). However, for standards like ISO 2859-1, specific sampling plans (sample sizes and acceptable quality limits - AQLs) are defined within the standard itself for batch testing.
The data provenance is from Thailand (SGMP Company Limited is in Thailand). The data is retrospective in the sense that the testing was conducted prior to submission for regulatory clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for examination gloves does not typically involve "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images). Instead, the "ground truth" is adherence to the performance specifications defined by the ASTM and ISO standards themselves. The "experts" involved would be the qualified laboratory personnel performing the standardized tests according to the written protocol of each standard. Their qualifications would be in laboratory practices, quality control, and the specific test methodologies. The number of such personnel is not specified.
4. Adjudication Method
Not applicable for this type of device and testing. Test results against established standards do not typically involve adjudication among multiple human readers. Outcomes are binary: pass/fail the standard's defined limits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not the type of device where MRMC studies are performed. MRMC studies are typically for diagnostic imaging devices where human interpretation is a key component.
6. Standalone Performance Study
Yes, in a sense. The compliance with ASTM and ISO standards demonstrates the standalone performance of the device (the glove itself, without a human "in-the-loop" in the way an AI diagnostic tool would have). The biocompatibility testing also evaluates the standalone biological performance of the glove material.
7. Type of Ground Truth Used
The ground truth used is primarily performance specifications defined by internationally recognized standards (ASTM and ISO), along with biocompatibility testing results.
- ASTM D6319-00a(2005): Defines physical properties (e.g., tensile strength, elongation, force at break) for nitrile examination gloves.
- ISO 2859-1 / ASTM D5151-06: Specifies acceptable levels of pinholes in gloves.
- ASTM D6124-06: Specifies limits for residual powder.
- Biocompatibility Testing: Involves a series of tests (often based on ISO 10993 standards, though not explicitly stated here for gloves) to assess the biological response to the device, conducted on animals (White Rabbits and Guinea Pigs).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm requiring a "training set." The testing performed is to demonstrate compliance of manufactured batches with established performance standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.