(66 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a and FDA Water leak test.
The provided document describes the acceptance criteria and a study for "Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves" manufactured by GREEN PROSPECT SDN. BHD.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D6319-00a & FDA) | Reported Device Performance (Powder Free Nitrile Exam Gloves) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI, AQL = 2.5 | Pass GI, AQL = 2.5 |
| 2. Length (mm) | XS: Min 220, S: Min 220, M: Min 230, L: Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | XS: 70 ± 10, S: 80 ± 10, M: 95 ± 10, L: 111 ± 10 | XS: 73-78, S: 83-88, M: 93-98, L: 103-107 |
| 4. Thickness (mm) (Single Layer) | Finger: Min 0.05, Palm: Min 0.05 | Finger: Min 0.08, Palm: Min 0.08 |
| 5. Physical Properties Before Aging | Tensile Strength (MPa): Min 14, Ultimate Elongation (%): Min 500 | Tensile Strength (MPa): 23-26, Ultimate Elongation (%): 700-840 |
| 5. Physical Properties After Aging | Tensile Strength (MPa): Min 14, Ultimate Elongation (%): Min 400 | Tensile Strength (MPa): 18-24, Ultimate Elongation (%): 660-760 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for each individual test (e.g., how many gloves were tested for watertightness or physical properties). However, the performance data is based on "ASTM D6319-00a2 and FDA 1000ML watertight test." ASTM standards typically specify sampling plans. For instance, for watertightness, it specifies an "AQL = 2.5" (Acceptable Quality Limit), which is part of a sampling plan, but not the exact number of units tested.
The data provenance is from Malaysia (Green Prospect Sdn Bhd is located in Perak Darul Ridzuan, Malaysia) and appears to be retrospective in nature, as it's a summary of performance data already collected.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for these tests are the objective measurement standards established by ASTM D6319-00a and FDA regulations, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective measurements against established standards (ASTM and FDA specifications), not subjective assessment requiring adjudication.
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 diagnostic devices involving human interpretation of data, which is not the case for examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance study was not done. This device is a physical product (examination gloves), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is objective measurement against established industry standards and regulatory requirements. Specifically:
- ASTM D6319-00a: Standard Specification for Nitrile Examination Gloves for Medical Application.
- FDA 1000ML watertight test: A specific regulatory requirement for watertightness.
- FDA Requirements for powder content.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical product evaluated against standards, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.