(87 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.
This document describes the safety and performance of Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) as submitted for FDA 510(k) clearance (K213048). The study focuses exclusively on comprehensive bench testing and biocompatibility assessments, demonstrating the device's adherence to established standards for medical gloves, particularly regarding chemotherapy drug permeation.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): | |
| XS: ≥220; | |||
| S/M/L/XL/XXL: ≥230 | |||
| Width (mm): | |||
| XS: 70±10; | |||
| S: 80±10; | |||
| M: 95±10; | |||
| L: 110±10; | |||
| XL: 120±10; | |||
| XXL: 130±10 | |||
| Thickness (mm): | |||
| Finger: ≥0.05; | |||
| Palm: ≥0.05 | Length (mm): | ||
| All sizes: > 240/Pass | |||
| Width (mm): | |||
| XS: 80-83/Pass | |||
| S: 86-90/Pass | |||
| M: 97-98/Pass | |||
| L: 108-112/Pass | |||
| XL: 115-120/Pass | |||
| XXL: 128-130/Pass | |||
| Thickness (mm): | |||
| Finger: 0.08-0.10/Pass | |||
| Palm: 0.08-0.11/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies that out of 125 samples tested, 0 failed, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 240 minutes for many drugs, but lower times are accepted for certain highly permeable drugs, provided they are clearly labeled with warnings. | Carboplatin: > 240 Minutes |
| Carmustine (BCNU): 26.5 Minutes (Warning advised) | |||
| Cyclophosphamide: > 240 Minutes | |||
| Doxorubicin: > 240 Minutes | |||
| Etoposide: > 240 Minutes | |||
| Fluorouracil: > 240 Minutes | |||
| Methotrexate: > 240 Minutes | |||
| Paclitaxel: > 240 Minutes | |||
| ThioTepa: 48.4 Minutes (Warning advised) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of units (gloves) for each test, but it does refer to meeting ASTM standards, which would imply a scientifically sound sampling methodology.
For the Watertightness Test, the results state "0/125/Pass," indicating a sample size of 125 units was tested for holes.
The data provenance is based on non-clinical laboratory testing (bench testing) performed by or for Huayuan Medical Technology (Shangqiu) Co., Ltd. The specific location of testing is not detailed beyond the company's address in Shangqiu City, Henan Province, China. The data would be considered prospective for the purposes of this 510(k) submission, as these tests were conducted to demonstrate compliance for the specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on objective, standardized bench tests (e.g., ASTM, ISO standards) to establish performance. The "ground truth" is defined by the technical specifications and criteria outlined in these industry-recognized standards, rather than expert consensus on subjective data (like image interpretation in AI/clinical studies). No human experts were used to establish ground truth in the context of clinical/radiological assessment. The experts involved would be laboratory technicians and engineers qualified to perform and interpret the specified physical, chemical, and biological tests according to the standards.
4. Adjudication Method for the Test Set
Not applicable. Since the study involves objective bench testing against pre-defined acceptance criteria from international standards (ASTM, ISO), no human adjudication of test results is typically required beyond standard quality control and verification procedures of the testing laboratory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This K213048 submission is for Nitrile Patient Examination Gloves, which are a physical medical device, not a diagnostic imaging AI system. Therefore, an MRMC comparative effectiveness study, which is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, was not performed. The study focuses on the physical and chemical properties of the gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Not applicable. This is not an AI-powered diagnostic device or software. The "performance" being assessed is the physical and chemical resistance of the gloves, which is inherently a standalone performance of the material and manufacturing process under controlled laboratory conditions.
7. The Type of Ground Truth Used
The "ground truth" for this device is established by objective laboratory measurements against pre-defined technical specifications and performance criteria set forth in internationally recognized standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ASTM D6978-05, ISO 10993-5, ISO 10993-10). For example, the ground truth for "tensile strength" is a measured force in MPa, which is then compared to an acceptance criterion (e.g., ≥14MPa). For chemotherapy drug permeation, the ground truth is the measured breakthrough time in minutes.
8. The Sample Size for the Training Set
Not applicable. This is a traditional medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set." The manufacturing process for physical gloves does not involve machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical device like examination gloves.
§ 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.