(92 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 four sizes: small, medium, large, and extra-large. The subject device is non-sterile.
Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves
This document outlines the acceptance criteria and details the studies conducted to demonstrate that the "Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230 | |
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | |||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): > 240/Pass (for all sizes) | ||
| Width (mm): S: 88-89 /Pass; M: 94-97/ Pass; L: 103-107/Pass; XL: 114-116/Pass | |||
| Thickness (mm): Finger: 0.10-0.11/Pass; Palm: 0.07-0.08/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 20 Minutes (Predicate's acceptance criteria was >20 minutes, though the predicate showed 11.8 min and 31.6 min depending on color - subject device had 1.9 min, leading to a warning for this drug). | |
| Cisplatin 1.0 mg/ml: > 20 Minutes | |||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||
| Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes | |||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | |||
| Etoposide 20.0 mg/ml: > 240 Minutes | |||
| Fluorouracil 50.0 mg/ml: > 240 Minutes | |||
| Paclitaxel 6.0 mg/ml: > 20 Minutes (Predicate's acceptance criteria was >20 minutes, though the predicate showed >240 min). | |||
| ThioTepa 10.0 mg/ml: > 20 Minutes (Predicate's acceptance criteria was >20 minutes though the subject device had 11.3 min, leading to a warning for this drug). | Carmustine (BCNU) 3.3 mg/ml: 1.9 Minutes (Warning: Do not use) | ||
| Cisplatin 1.0 mg/ml: > 240 Minutes | |||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||
| Dacarbazine 10.0 mg/ml: > 240 Minutes | |||
| Doxorubicin HCL 2.0 mg/ml: > 240 Minutes | |||
| Etoposide 20.0 mg/ml: > 240 Minutes | |||
| Fluorouracil 50.0 mg/ml: > 240 Minutes | |||
| Paclitaxel 6.0 mg/ml: > 240 Minutes | |||
| ThioTepa 10.0 mg/ml: 11.3 Minutes (Warning: Do not use) |
Note: For Carmustine (BCNU) and ThioTepa, the device performance did not meet the implicitly accepted longer breakthrough times of the predicate device for safe use, and as such, a warning was issued for non-use with these specific drugs. For other drugs, the device demonstrated comparable or superior performance to the predicate.
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, for the Watertightness Test (ASTM D5151), the result "0/125/Pass" indicates a sample size of 125 gloves were tested, and none failed.
The data provenance is implied to be prospective bench testing conducted specifically for the submission of this device, presumably within China, given the manufacturer's and correspondent's addresses. There is no information provided regarding country of origin of data beyond the manufacturer's location.
3. Number of Experts and Qualifications for Ground Truth
This section is not applicable as the studies are primarily bench testing of physical and chemical properties of a medical device (gloves). The "ground truth" for these tests is established by published ASTM and ISO standards and their specified methodologies, not by expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable as the studies involve objective physical and chemical testing against established standards, not interpretation of data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a medical glove, and the evaluation does not involve diagnostic imaging or human-in-the-loop performance with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a medical glove, not an algorithm, and its performance is assessed directly through physical and chemical testing.
7. Type of Ground Truth Used
The ground truth used for these studies is based on:
- Established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards: These standards define the test methodologies, performance criteria (e.g., minimum tensile strength, maximum powder content, minimum breakthrough times for chemotherapy drugs, irritation/sensitization levels), and acceptable limits.
- Objective laboratory measurements: Physical dimensions, tensile strength, elongation, watertightness, powder content, and chemical permeation breakthrough times were measured directly according to the specified standard test methods.
8. Sample Size for the Training Set
This is not applicable. The device is a physical product (medical gloves), not an AI algorithm that requires a training set. The performance is based on direct testing of the product itself.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the relevant ASTM and ISO standards as mentioned in point 7.
§ 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.