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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.

Device Description

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.

AI/ML Overview

The provided document describes the acceptance criteria and performance of the Nitrile Powder Free Patient Examination Gloves, Blue Color based on non-clinical performance data, as clinical data was not deemed necessary for this device.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

Characteristics	Standard / Acceptance Criteria	Device Performance
Dimension	ASTM standard D 6319-10 (For Length, Width, Thickness)	Meets ASTM standard D 6319-10 (Length: ≥230mm min for all sizes; Width: Small 84-86mm, Medium 94-97mm, Large 105-109mm, X large 114-119mm; Thickness: Finger 0.10mm min, Palm 0.06mm min)
Physical Properties	ASTM standard D 6319-10 (Before aging/after aging: Elongation ≥500%, Tensile Strength ≥ 14MPa)	Meets ASTM standard D 6319-10 (Before aging/after aging: Elongation: 520-580%, Tensile Strength: 22-34 MPa)
Freedom from pinholes	21 CFR 800.20; ASTM D6319-10; ASTM D 5151-06 (Reapproved 2011) (Specifically, for waterleak test on pinhole AQL 2.5 at Inspection Level I)	Meets ASTM D 5151-06 (Reapproved 2011) - Holes at Inspection Level I, AQL 2.5
Powder Residual	ASTM standard D 6319-10 and D6124-06 (Reapproved 2011) (< 2mg/glove)	Meets (< 2mg/glove)
Biocompatibility	Primary Skin Irritation in rabbits (ISO 10993-10: Third Edition 2010-08-01); Dermal sensitization in the guinea pig (ISO 10993-10: Third Edition 2010-08-01)	Passes (Not a Primary Skin Irritation; Not a Dermal sensitization under the conditions of the study)
Materials	Nitrile; PU as Dusting or Donning Powder	Nitrile; PU (Surface Coating Agent)
Intended Use	Non-sterile disposable device for medical purposes, worn on the examiner's hand/finger to prevent contamination between patient and examiner.	Intended Use is Similar to the predicate device: Non-sterile disposable device for medical purposes, worn on the examiner's hand/finger to prevent contamination between patient and examiner. (Note: The provided text refers to it as "disposable device" in the comparison table).
Single Patient Use	Single Patient Use	Single Patient Use (Similar)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the specific tests (e.g., how many gloves were tested for pinholes, physical properties, or biocompatibility).
The data provenance is from China, as the submitter, Zhida Glove Co., Ltd., is located in Hebei Province, China. The document does not specify whether the data is retrospective or prospective, but given it's for a 510(k) submission, it would typically be collected as part of product development and testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the reported tests are for physical, chemical, and biological performance of a medical glove, not for diagnostic interpretation requiring human expert consensus. The "ground truth" for these tests is established by adherence to recognized international and national standards (ASTM, ISO, 21 CFR).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical imaging studies where disagreements between human readers need to be resolved. The tests performed for this device are objective measurements against established standards.
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. This is a medical device (patient examination glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical product (glove), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests conducted on the gloves is based on established industry standards and regulatory requirements. Specifically:
- ASTM standards (D6319-10 for dimensions and physical properties, D5151-06 for freedom from pinholes, D6124-06 for powder residual)
- Federal Regulations (21 CFR 800.20 for freedom from pinholes)
- ISO standards (ISO 10993-10: Third Edition 2010-08-01 for biocompatibility)
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 concept of a "training set" for an algorithm. The manufacturing process is subject to quality control, which involves testing samples from production batches.
9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

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