Search Results
Found 1 results
510(k) Data Aggregation
(207 days)
Nitrile Powder Free Patient Examination Gloves, Blue color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The provided document is a 510(k) summary for Nitrile Powder Free Patient Examination Gloves, Blue Color. This document describes the device's characteristics and its comparison to a predicate device to establish substantial equivalence, not a study performing extensive clinical trials typically associated with AI/ML devices. Therefore, many of the requested criteria regarding AI device performance are not applicable to this submission.
Here's an analysis of the provided information relative to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM and CFR standards.
| Characteristic | Standard/Acceptance Criteria | Device Performance |
|---|---|---|
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 (Before/After aging: Elongation $\ge$ 500%, Tensile Strength $\ge$ 14MPa) | Meets (Elongation: 520-580%, Tensile Strength: 22-34 MPa) |
| Freedom from pinholes | 21 CFR 800.20, ASTM D 5151-06 (Reapproved 2011), AQL 2.5 (Inspection Level I) | Meets |
| Powder Residual | ASTM D 6319-10, ASTM D 6124-06 (Reapproved 2011) | Meets (< 2mg/glove) |
| Biocompatibility | Primary Skin Irritation (ISO 10993-10: 2010-08-01) | Passes (Not a Primary Skin Irritation) |
| Dermal Sensitization (ISO 10993-10: 2010-08-01) | Passes (Not a Dermal Sensitization) | |
| Length | ASTM D6319-10 ($ \ge \text{230mm min}$) | 230mm min for all sizes |
| Width | ASTM D6319-10 (Small 70-90mm, Medium 85-105mm, Large 100-120mm, Xlarge 110-130mm) | Small 84-86mm, Medium 94-97mm, Large 104-109mm, Xlarge 114-119mm |
| Thickness | ASTM D6319-10 (Finger 0.05mm min, Palm 0.05mm min) | Finger 0.10mm min, Palm 0.06mm min |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs for biocompatibility). The testing is described generally as meeting ASTM and ISO standards. The data provenance is implied to be from the manufacturer's testing facilities in China (Submitter's address: Xigaozhuang, Pachigang Town, Luannan County, Hebei Province, 063502, China). The studies are "non-clinical performance data" and are retrospective in the sense that they were conducted for the purpose of this submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. For this type of device (patient examination gloves), "ground truth" would typically refer to objective measurements and chemical/physical analyses performed by qualified laboratory technicians and specialists, rather than clinical experts or radiologists. The document references specific ASTM and ISO standards, which dictate the methodology for these tests.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The tests are based on objective pass/fail criteria according to established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is typically performed for diagnostic imaging devices where human readers interpret results. This is a purely physical/chemical performance device (patient examination glove) and not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is not applicable as the device is a physical medical glove and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth is based on objective measurements and laboratory testing defined by recognized international and national standards:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- 21 CFR 800.20 (Regulations for pinhole testing)
- ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
8. The Sample Size for the Training Set
This question is not applicable. The device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
Ask a specific question about this device
Page 1 of 1