(59 days)
The Powder Free Latex Examination Gloves, Non-Sterile (Protein Content Labeling 50 µg/g or less) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling 50 ug/q or less) is Class I Device, Code No. 80LYY. These gloves are made of natural rubber latex. Based on the protein content test result obtained the aloves are well bellow 50 ug/g and support our protein content labeling claim.
The provided text describes a 510(k) summary for "Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50ug/g or less)". This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study on a new device's performance against detailed acceptance criteria for an AI/algorithm.
The "acceptance criteria" and "device performance" in this context refer to the physical and chemical properties of the gloves themselves, compared against established standards for examination gloves and the specific protein content claim. The "study" described is the testing conducted on the gloves to demonstrate conformance to these standards and the protein content claim.
Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" and "device performance" in the context of this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Claim) | Reported Device Performance |
|---|---|
| Material | Natural Rubber Latex |
| Sterility | Non-Sterile |
| Protein Content Labeling Claim (Total Water Extractable Protein) | 50 µg/g or less (stated to be "well below 50 ug/g" based on test results) |
| Compliance with ASTM D 3578 (Standard Specification for Rubber Examination Gloves) | Meets |
| Compliance with FDA 1000ml Water Leak Test | Meets |
| Intended Use (Prevention of contamination between patient and examiner) | Meets (As per intended use statement) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for each specific test (e.g., protein content, ASTM D 3578, water leak test). It generally states that "The result of the performance testing... are detailed in this submission."
- Sample Size: Not explicitly stated for the test set of gloves.
- Data Provenance: The manufacturing company is PT. WRP Buana Multicorpora, located in Indonesia. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but performance testing for a 510(k) submission typically involves prospective testing of production samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information (number of experts, their qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). For the physical and chemical testing of examination gloves, "ground truth" is established by laboratory measurements and adherence to specified testing protocols (e.g., ASTM standards). Therefore, this question is not directly applicable in the conventional sense to this device. The "experts" would be qualified laboratory technicians or engineers performing the tests.
4. Adjudication Method for the Test Set
Again, adjudication methods like 2+1 or 3+1 are primarily used for reaching consensus among multiple human reviewers/experts, particularly in studies involving subjective interpretation. For objective laboratory tests on gloves, adjudication is not typically performed in this manner. The results are based on direct measurement and comparison to predefined thresholds.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved. This submission is for physical examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, this pertains to a physical medical device (examination gloves), not an algorithm or AI. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of these gloves is based on:
- Laboratory Testing Results: Direct measurements of physical properties (e.g., water leak test) and chemical properties (e.g., protein content determination).
- Adherence to Established Standards: Conformance to recognized industry standards such as ASTM D 3578.
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is 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.