(112 days)
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.
The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves (YK0001). It addresses the substantial equivalence of the device to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a predicate device, often through performance testing against established standards, rather than through extensive clinical trials for new medical technologies.
Therefore, the study design described in the prompt, addressing AI performance, MRMC studies, and detailed ground truth establishment, is not applicable to this specific medical device (examination gloves). The document details the physical and chemical properties of the gloves and their compliance with relevant ASTM and ISO standards.
Here's the information extracted that aligns with the prompt's request for acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a non-AI medical device (Nitrile Powder Free Examination Gloves). The acceptance criteria are based on established national and international standards for medical gloves.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): |
- Small: ≥230mm
- Medium: ≥230mm
- Large: ≥230mm
- X large: ≥230mm
Width (mm): - Small: 85±10mm
- Medium: 95±10mm
- Large: 110±10mm
- X large: 115±10mm
Thickness (mm) Finger: - Small: ≥0.05mm
- Medium: ≥0.05mm
- Large: ≥0.05mm
- X large: ≥0.05mm
Thickness (mm) Palm: - Small: ≥0.05mm
- Medium: ≥0.05mm
- Large: ≥0.05mm
- X large: ≥0.05mm | Length (mm):
- Small: 231-238/Pass
- Medium: 244-248/Pass
- Large: 245-249/Pass
- X large: 240-244/Pass
Width (mm): - Small: 85-86/Pass
- Medium: 96-97/Pass
- Large: 106-108/Pass
- X large: 113-114/Pass
Thickness (mm) Finger: - Small: 0.097-0.111/Pass
- Medium: 0.110-0.131/Pass
- Large: 0.110-0.129/Pass
- X large: 0.116-0.128/Pass
Thickness (mm) Palm: - Small: 0.064-0.068/Pass
- Medium: 0.065-0.069/Pass
- Large: 0.060-0.065/Pass
- X large: 0.059-0.066/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | No water leakage (Inspection Level I, AQL 2.5, as per ASTM D6319-19 and 21 CFR 800.20) | 0/125/Pass |
| ASTM D6124 | Powder Content |
§ 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.