(107 days)
A 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.
It is the powder-free variation of the class I latex patient examination gloves made by online polymer-coating and on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive to the powdered version of the same gloves.
The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder Free Nitrile Examination Glove, Blue (Colored)". The device is being submitted for 510(k) premarket notification to establish substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Regulation | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Water Tight Test, 1000 ml | ASTM D6319-10, ASTM D5151-06 | G-I, AQL 2.5 (FDA GII, AQL 2.5) | Meets ASTM D6319-10, Meets ASTM D5151-06 |
| Physical Properties | ASTM D6319-10 | ||
| * Before Ageing: | |||
| - Tensile Strength | Min. 14 Mpa | Meets ASTM D6319-10 | |
| - Ultimate Elongation | Min. 500 % | Meets ASTM D6319-10 | |
| * After Ageing: | |||
| - Tensile Strength | Min. 14 Mpa | Meets ASTM D6319-10 | |
| - Ultimate Elongation | Min. 400 % | Meets ASTM D6319-10 | |
| Powder Content | ASTM D6319-10, ASTM D6124-06 | Max. 2mg/glove | Meets ASTM D6319-10, Meets ASTM D6124-06 |
| Biocompatibility Test | |||
| - Primary Skin Irritation Test | ISO 10993-10 (For sens.), 16CFR Part 1500 (For irrit.) | No Animal Irritation | Passes, Did not cause an irritant response |
| - Dermal Sensitization Test | ISO 10993-10 | No Animal Sensitization | Passes, Did not produce a skin sensitization effect |
| Dimensions | ASTM D6319-10 | Meet Specification | Meet Specification |
| Freedom from pin-holes | ASTM D5151-06 | Meet Specification | Meet Specification |
| Powder Free Residue | ASTM D6124-06, ASTM D6319-10 | Meet Specification | Meet Specification |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for water tightness, physical properties, or powder content).
- For biocompatibility tests, it mentions "No Animal Irritation" and "No Animal Sensitization," implying animal studies were conducted, but the number of animals or the specific details of the studies are not provided.
- Data Provenance: The manufacturing company is "Careplus (M) SDN BHD" located in Malaysia. The tests were presumably conducted as part of their manufacturing and quality control process. The studies appear to be prospective as they are conducted to demonstrate the performance of the device for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. The "ground truth" for these types of physical and biocompatibility tests on medical gloves is typically established by laboratory testing against defined ASTM and ISO standards, rather than expert consensus on subjective data.
4. Adjudication Method for the Test Set
- This information is not applicable for the type of tests conducted. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostics where human readers interpret data, and discrepancies need to be resolved. The tests mentioned here are objective laboratory measurements.
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
- This information is not applicable to this device. This document describes a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable to this device, as it is not an algorithm or AI system.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is established by objective measurements against established national and international standards. These include:
- Physical Property Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06
- Biocompatibility Standards: ISO 10993-10, 16CFR Part 1500
- The results are compared directly to the quantitative requirements specified in these standards.
8. The Sample Size for the Training Set
- This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
§ 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.