(62 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) 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 extralarge.
The provided text describes the acceptance criteria and performance data for "Nitrile Exam Gloves, Powder Free, Blue (Tested for Use with Chemotherapy Drugs)" in the context of an FDA 510(k) premarket notification.
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 mm; M/L/XL: ≥230 mm. Width (mm): S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm. Thickness (mm): Finger: ≥0.05mm; Palm: ≥0.05mm. | Length: >230 mm (Pass) Width: S: 81-86, M: 93-99, L: 104-109, XL: 113-116 (Pass) Thickness: Finger: 0.11-0.15mm, Palm: 0.08-0.15mm (Pass) |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 240 Minutes. Cyclophosphamide: > 240 Minutes. Dacarbazine: > 240 Minutes. Doxorubicin HCl: > 240 Minutes. Etoposide: > 240 Minutes. Fluorouracil: > 240 Minutes. Methotrexate: > 240 Minutes. Mitomycin C: > 240 Minutes. Paclitaxel: > 240 Minutes. Thio Tepa: 57.4 Minutes. Vincristine Sulfate: > 240 Minutes. |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Biocompatibility Tests: The specific sample sizes for each physical property test (e.g., length, width, thickness, tensile strength, elongation, powder content, holes) and biocompatibility tests (cytotoxicity, irritation, sensitization) are not explicitly stated. However, the results (e.g., "0/125 leaks" for watertightness) indicate that a sample was tested.
- Chemotherapy Drug Permeation Test: The sample size for the chemotherapy drug permeation testing is not explicitly provided.
- Data Provenance: The document does not specify the country of origin of the data for these tests. The tests were presumably conducted by or for Hengchang (Dongying) Medical Technology Co., Ltd. in China. The study is a prospective evaluation of the manufactured gloves against specific standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the studies described are bench tests and biocompatibility tests for a physical medical device (gloves), not studies involving human interpretation of clinical data or images. Ground truth is established by standardized testing protocols and measurements, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication is not relevant for physical and chemical standardized tests. Test results are objective measurements against defined criteria.
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
Not applicable. This device is a pair of examination gloves, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- For physical properties and safety (holes, powder content, dimensions, tensile strength, elongation): Ground truth is established by adherence to recognized industry standards and their specified test methodologies (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412). The "ground truth" is the quantitative measurement of these properties.
- For biocompatibility (cytotoxicity, irritation, sensitization): Ground truth is established by adherence to recognized international standards for biological evaluation of medical devices (ISO 10993-5, ISO 10993-10). The "ground truth" is the observed biological response in the specified test models.
- For chemotherapy drug permeation: Ground truth is established by adherence to recognized industry standards for assessing resistance to chemotherapy drugs (ASTM D6978-05). The "ground truth" is the measured breakthrough detection time.
8. The Sample Size for the Training Set
Not applicable. This is a physical device being tested against standards, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is relevant to this type of device and testing.
§ 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.