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A patient examination glove is a disposable device made of Nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder Free Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves 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 and it is a single use device.

AI/ML Overview

The document describes the non-clinical testing of a "Powder Free Nitrile Examination Glove - Black, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method	Standard	Purpose of Testing	Acceptance Criteria	Reported Device Performance	Status
Physical Properties	ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension)	To evaluate the tensile (tension) properties of glove.	Before aging: Tensile strength Min 14.0 MPa; Ultimate elongation Min 500%	Before aging: Tensile strength 29.7 Mpa; Ultimate elongation 585%	Pass
			After aging: Tensile strength Min 14.0 MPa; Ultimate elongation Min 400%	After aging: Tensile strength 33.1 Mpa; Ultimate elongation 554%	Pass
Dimension	ASTM D3767 (Standard Practice for Rubber—Measurement of Dimensions)	To measure the length, width and thickness of glove.	X-Small: Length Min 240 mm, Width 70 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm	Length 250 mm, Width 78.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm	Pass
			Small: Length Min 240 mm, Width 80 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm	Length 250 mm, Width 88.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm	Pass
			Medium: Length Min 240 mm, Width 95 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm	Length 250 mm, Width 98.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm	Pass
			Large: Length Min 240 mm, Width 110 ± 10 mm, Thickness Finger – min 0.05mm, Palm - min 0.05mm	Length 249 mm, Width 108 mm, Thickness Finger – 0.10 mm, Palm - 0.07 mm	Pass
			X-Large: Length Min 240 mm, Width 120 ± 10 mm, Thickness Finger – min 0.05mm, Palm - min 0.05mm	Length 250 mm, Width 118 mm, Thickness Finger – 0.10 mm, Palm - 0.07 mm	Pass
Watertight	ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)	To detect holes that leak water and thereby compromise the usefulness of the glove.	Sample size: 500 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10	Batch size: 150,001 to 500,000. Sample drawn (code M): 315 pieces. 0 pieces found with leaks. Within acceptance criteria.	Pass
Residual Powder	ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)	To determine the amount of residual powder and non-powder solids found on gloves.	Less than 2 mg per glove	Sample size: 5 pcs. Requirement: <2mg/glove. Result: 0.20 mg/glove.	Pass
Biocompatibility - Primary Skin Irritation	ISO 10993-10:2010	To assess the potential of the material producing skin irritation.	Non-Irritant	The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'.	Pass
Biocompatibility - Dermal Sensitization	ISO 10993-10:2010	To assess the potential of the material producing skin sensitization.	Non-Irritant	The test material did not produce a skin sensitization effect in the guinea pigs.	Pass
Biocompatibility - Cytotoxicity	ISO 10993-5: 2009 (E)	To assess the in vitro cytotoxicity of the material.	Non-Toxicity	The test material demonstrated a cytotoxic effect under the condition of this study. Additional test i.e. Acute Systemic Toxicity was tested. (Initial test result was a "Fail" due to observed cytotoxic effect, leading to the additional test.)	Fail*
Biocompatibility - Acute Systemic Toxicity	ISO 10993-11:2017 (E)	To assess the potential of material to cause adverse systemic reactions.	Non-Toxicity	The test item did not induce any systemic toxicity in Swiss albino mice. (This was performed as an additional test after the cytotoxicity test showed a cytotoxic effect, bringing the overall biocompatibility evaluation to a "Pass" for systemic effects).	Pass

Note on Cytotoxicity: While the initial cytotoxicity test resulted in a "Fail" due to the observed cytotoxic effect in vitro, an additional in vivo Acute Systemic Toxicity test was conducted, which passed. The conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate devices K190942," implying that the comprehensive biocompatibility assessment led to an acceptable safety profile.

2. Sample Size Used for the Test Set and the Data Provenance:

Physical Properties (Tensile Strength & Elongation): Specific sample size not explicitly stated, but tests were conducted according to ASTM D412, which defines sampling procedures.
Dimensions: Not specified. ASTM D3767 is referenced, implying adherence to its sampling guidelines.
Watertight (Hole Detection): A sample size of 315 pieces was drawn from a batch size of 150,001 to 500,000.
Residual Powder: A sample size of 5 pcs was used.
Biocompatibility (Primary Skin Irritation, Dermal Sensitization): Not explicitly stated, but typically involves a certain number of animal subjects (e.g., guinea pigs as mentioned for dermal sensitization). Testing was done according to ISO 10993-10.
Biocompatibility (Cytotoxicity - MEM Elution): Not explicitly stated, but tested according to ISO 10993-5. In vitro test.
Biocompatibility (Acute Systemic Toxicity): Not explicitly stated, but involved Swiss albino mice, tested according to ISO 10993-11.

Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be generated from non-clinical laboratory testing performed by or for the manufacturer, Hong Seng Gloves Sdn Bhd, which is based in Malaysia. The studies are prospective in nature, as they involve testing the subject device to evaluate its performance against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable as the document describes non-clinical laboratory testing of a medical device (gloves), not studies that rely on expert interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by established performance standards (e.g., ASTM, ISO) and laboratory measurements.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on medical findings. Here, the assessment is based on objective laboratory measurements against predefined 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 document pertains to the regulatory submission for a medical device (examination gloves) and describes non-clinical performance testing. It does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. This document describes the performance of a physical medical device (examination gloves), not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established by international and national standards (e.g., ASTM D6319, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ISO 10993 series) and their defined acceptance criteria. These standards provide objective, measurable parameters (e.g., minimum tensile strength, maximum powder residue, AQL for watertightness, non-toxic response) that the device must meet.

8. The Sample Size for the Training Set:

This information is not applicable. This document describes the testing of a manufactured product against specified standards, not the development or training of a machine learning model. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8. There is no training set for this type of device submission.

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