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510(k) Data Aggregation
(127 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.
Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Device: Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Status | ISO11137-1:2006 (Non-Sterile) | Non-Sterile |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Thickness | ASTM D6319-10 | Meets |
| Powder Free | ASTM D6124-06 | Meets (< 2 mg/glove) |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation - ISO 10993-10:2002(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Passes (Non Primary Irritant). No erythema or oedema noted on abraded or non-abraded sites at 24±1 hours and 72±1 hours after application. The Primary Irritation Index (PII) of test material was "0". |
| Biocompatibility: Dermal Sensitization | Dermal Sensitization - ISO 10993-10:2002(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4) | Passes (Not a contact sensitizer). No positive allergic reaction observed during the challenge phase (at 0±2, 24±2 hours and 48±2 hours) in animals treated with the test material and negative control. |
| Watertight | ASTM D5151-06 (1000ml) | Passes |
| Intended Use | For medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Meets stated intended use. |
| Material | ASTM D6319-10 (Nitrile) | Nitrile |
| Color | - (Predicate: Blue) | Black (Note: This is a deviation from the predicate but considered not significant as per the summary) |
| Texture | - (Finger textured) | Finger textured |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use |
| Manufacturer | - | WRP Asia Pacific Sdn Bhd |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state specific sample sizes for tests like biocompatibility or watertightness. The performance is reported against ASTM and ISO standards, which typically involve defined sample sizes. For example, ASTM D6319-10 and ASTM D5151-06 would specify the number of gloves to be tested for dimensions, physical properties, and watertightness. However, these specific numbers are not provided in this 510(k) summary.
The data provenance is not explicitly stated as country of origin, but the manufacturer is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing would presumably have been conducted in accordance with international standards (ASTM, ISO) adopted by the FDA. The text describes non-clinical performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided. The ground truth for this device (examination gloves) is established through adherence to recognized international and national standards (ASTM, ISO, FDA regulations) that specify physical, chemical, and biological performance requirements. There are no "experts" establishing ground truth in the sense of medical diagnosis; it's about meeting engineering and material performance specifications.
4. Adjudication Method for the Test Set:
Not applicable. This device's performance is objectively measured against quantifiable standards, not through subjective human 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 or AI-assisted devices where human interpretation is involved. For examination gloves, the performance is assessed through material and physical property testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. "Standalone performance" refers to the performance of an algorithm or AI system without human involvement. This device is a physical medical device (gloves), not a software or AI product.
7. The Type of Ground Truth Used:
The ground truth used is based on International and National Standards Specifications. These include:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
- ISO 10993-10:2002(E) (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (related to primary skin irritation and dermal sensitization)
- Medical Glove Guidance Manual - Labeling
- FDA 21 CFR 880.6250 (Patient Examination Gloves regulations)
8. The Sample Size for the Training Set:
Not applicable. Examination gloves are physical devices, not machine learning models. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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