Search Results

The Medical Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: S,M,L,XL. The subject device is non-sterile.

AI/ML Overview

The provided text describes the 510(k) summary for the "Medical Nitrile Examination Gloves" (K220066). This document is for a Class I medical device (non-powdered patient examination glove), which is a low-risk device. For such devices, clinical testing is typically not required, and the focus of the submission is on non-clinical performance and substantial equivalence to a predicate device.

Therefore, the requested information regarding AI device performance, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this specific submission. This document details the testing of physical properties and biocompatibility of examination gloves, not an AI or imaging device.

However, I can extract the acceptance criteria and performance data for the glove product based on the provided non-clinical testing summary.

Here's the relevant information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, for Medical Nitrile Examination Gloves)

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319 - Physical Dimensions Test
Length (mm)		S: ≥220; M/L/XL: ≥230	S: ≥220; Pass M/L/XL: ≥230; Pass
Width (mm)		S: 80±10; M: 95±10; L: 110±10; XL: 120±10	S: 83-88 /Pass M: 93-96/ Pass L: 104-109/ Pass XL: 110-116/ Pass
Thickness (mm)		Finger: ≥0.05; Palm: ≥0.05	Finger: 0.102-0.117/Pass Palm: 0.068-0.073/Pass
ASTM D5151 - Watertightness Test	For Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125/Pass (This implies 0 failures out of 125 samples tested)
ASTM D6124 - Powder Content		Meet the requirements of ASTM D6124 < 2.0mg	0.22mg/Pass
ASTM D412 - Physical Properties	Before Aging	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500%	Tensile Strength: 22.1-35.9 MPa/Pass; Ultimate Elongation: 505-588%/Pass
	After Aging	Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400%	Tensile Strength: 21.4-44.3MPa/Pass; Ultimate Elongation: 452-540%/Pass
ISO 10993-5 - Cytotoxicity		Device extract is cytotoxic (This seems to be a reporting of a finding, not an "acceptance criteria" for passing submission, but rather a characteristic. Given no other remarks, it likely indicates the test was performed, and the output confirmed, but not necessarily a "pass/fail" in the typical sense for this specific line. However, the ISO 10993-11 for systemic toxicity and ISO 10993-10 for irritation/sensitization are clearly "pass" for safety.)	Under conditions of the study, device extract is cytotoxic. (Note: For medical devices, this often means the extract was confirmed to cause a cytotoxic effect in vitro, and further evaluation/mitigation or context like the specific application/contact duration, and other biocompatibility tests like irritation and sensitization, inform the overall safety profile.)
ISO 10993-11 - Systemic Toxicity	Non-acute systemic toxicity	N/A (implicit acceptance is non-toxicity)	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10 - Irritation	Non-irritating	N/A (implicit acceptance is non-irritating)	Under the conditions of the study, not an irritant/ Pass
ISO 10993-10 - Sensitization	Non-sensitizing	N/A (implicit acceptance is non-sensitizing)	Under conditions of the study, not a sensitizer./ Pass

Points 2-9 are not applicable to this submission as it is not for an AI / imaging device.

Regarding the "study that proves the device meets the acceptance criteria," the "Summary of Non-clinical Testing" (Section 8.0) and "Table 2 - Summary of non-clinical performance testing" provide the evidence.

Sample sizes used for the test set and data provenance:
- For the Watertightness Test (ASTM D5151), the result "0/125/Pass" implies a sample size of 125 gloves were tested.
- Other tests (e.g., physical dimensions, strength, thickness, powder content, biocompatibility) would have specific sample sizes per the ASTM/ISO standards, but these are not explicitly stated in the summary table beyond the result itself (e.g., "S: 83-88 /Pass").
- Data provenance: Not explicitly stated, but typically non-clinical testing for medical devices is performed by accredited labs, often in the country of manufacture (China, in this case, as per the submitter's address). This is retrospective for the purpose of the submission.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. These are laboratory tests measuring physical and chemical properties, not human interpretation of images or clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
The type of ground truth used:
- For physical/chemical tests: The "ground truth" is defined by the technical specifications and methodologies outlined in the referenced ASTM and ISO standards (e.g., specific measurement techniques, chemical analyses, biological assays).
- For biocompatibility tests: The "ground truth" is based on the biological responses observed in the in vitro and in vivo models as per ISO 10993 standards.
The sample size for the training set: Not applicable (this is not an AI/ML device).
How the ground truth for the training set was established: Not applicable.

Ask a Question

Ask a specific question about this device

Page 1 of 1