FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

A 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 the patient and the examiner.

Device Description

Lano-E Powder-Free Nitrile Examination Glove. Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A. Powder Residue: Maximum 2mg/glove. Material: Nitrile. Cuff: Beaded. Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.

AI/ML Overview

This looks like a 510(k) submission for examination gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or human reader improvement with AI) is not applicable to this document.

The document describes the device, its intended use, and its compliance with ASTM standards for physical properties. The "study" here is essentially the testing performed to ensure the gloves meet these established standards.

Here's the relevant information adapted to the context of this device:

Acceptance Criteria and Device Performance (for Lano-E Powder-Free Nitrile Examination Glove)

The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging.

1. Table of Acceptance Criteria and Reported Device Performance

Inspection Parameters (Acceptance by Inspection Level and AQL)

Criteria	Inspection Level	AQL (Acceptance Quality Limit)
Dimensions	S-2	4.0
Physical Properties	S-2	4.0
Water Tight Test 1000ml	G-1	1.5
Visual Major Defects	G-1	1.5
Visual Minor Defects	G-1	2.5

Physical Properties (Before Aging)

Dimensions/Property	Acceptance Criteria	Reported Device Performance**
Overall Length	240 mm minimum	Met
Width (medium glove)	95 mm minimum	Met
Palm Thickness	0.10 to 0.15 mm	Met
Finger Thickness	0.10 to 0.17 mm	Met
Cuff Thickness	0.10 to 0.15 mm	Met
Tensile Strength	14.0 Mpa minimum	Met
Ultimate Elongation	700% minimum	Met
Pinhole AQL	1.5 minimum	Met

Physical Properties (After Aging)

Property	Acceptance Criteria	Reported Device Performance**
Tensile Strength	14.0 Mpa minimum	Met
Ultimate Elongation	500% minimum	Met
Pinhole AQL	1.5 minimum	Met

Note: The document explicitly states: "The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging." This implies that the device performance met all listed acceptance criteria.

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

Sample Size: The document does not specify a precise sample size for the testing of each individual criterion. However, the testing was conducted "in compliance with ASTM D6319-00 Rev A, EN 455-3 : 2000, EN 455-2 : 2000, EN 455-1 : 2000, ISO 2859-1:1999". These standards typically define the sampling plans (e.g., AQL tables) for quality control and testing.
Data Provenance: The device manufacturer, N.S. Uni-Gloves Sdn. Bhd., is based in Malaysia. The testing data would have been generated internally by the manufacturer or by a contracted laboratory following the specified international standards. The data is retrospective in the sense that it was collected as part of the product development and quality assurance process prior to the 510(k) submission.

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

Not Applicable: For this type of device (examination gloves), "ground truth" is established by adherence to measurable physical and chemical specifications outlined in established industry standards (like ASTM and EN standards). There are no "experts" in the sense of clinical reviewers establishing a subjective truth. The "truth" is objective measurement against a standard.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For examination gloves, the testing involves objective measurements (e.g., dimension, tensile strength, water tightness), which do not require human adjudication in the traditional sense. The pass/fail is determined by whether the measured value falls within the specified range or meets the AQL.

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

Not Applicable: This is an examination glove, not an AI/ML diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is an examination glove. There is no algorithm or AI component involved.

7. The type of ground truth used

Objective Standards and Measurements: The "ground truth" is defined by the objective, quantifiable specifications outlined in recognized international standards (ASTM D 6319-00 Rev A, EN 455 series, ISO 2859-1:1999) and the FDA 1000ml water tight test. This includes material properties, physical dimensions, and defect rates.

8. The sample size for the training set

Not Applicable: There is no "training set" in the context of examination gloves. The manufacturing process is controlled to produce gloves that consistently meet the specifications. Continuous quality monitoring, potentially using statistical process control, ensures ongoing adherence.

9. How the ground truth for the training set was established

Not Applicable: As there is no training set, this question is not applicable. The design and manufacturing process for the gloves are based on achieving the objective criteria defined by the standards.

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K Number

K013163

Device Name

UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES

Manufacturer

N.S. UNI-GLOVES SDN. BHD.

Date Cleared

2002-01-22

(123 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

A 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 the patient and the examiner.

Device Description

Trade Name: UniGlove Lano-E Powder-Free Latex Examination Glove
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Latex examination glove 80LYY that meets all the of requirements of ASTM Standard D 3578 - 00
Material: Latex
Cuff: Beaded
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D3578-00, EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989 and manufactured under GMP.
Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case

AI/ML Overview

The provided document describes the acceptance criteria and the study results for the UniGlove Lano-E Powder-Free Latex Examination Gloves.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Minimum/Maximum)	Reported Device Performance
Dimensions:
Overall Length	240 mm minimum	Meets
Width (medium glove)	95 mm minimum	Meets
Palm Thickness	0.15 to 0.20 mm	Meets
Finger Thickness	0.17 to 0.25 mm	Meets
Cuff Thickness	0.10 to 0.15 mm	Meets
Before Aging:
Tensile Strength	21 Mpa minimum	Meets
Ultimate Elongation	700% minimum	Meets
Pinhole AQL	1.5 minimum	Meets
After Aging:
Tensile Strength	16.0 Mpa minimum	Meets
Ultimate Elongation	500% minimum	Meets
Pinhole AQL	1.5 minimum	Meets
Inspection Parameters:
Dimensions	AQL 4.0 (Inspection Level S-2)	In compliance
Physical Properties	AQL 4.0 (Inspection Level S-2)	In compliance
Water Tight Test 1000ml	AQL 1.5 (Inspection Level G-1)	Meets
Visual Major Defects	AQL 1.5 (Inspection Level G-1)	In compliance
Visual Minor Defects	AQL 2.5 (Inspection Level G-1)	In compliance
Powder Residue	2 mg/glove maximum	In compliance
Protein Content Claim	50 Micrograms or Less	Meets

"Meets" or "In compliance" implies the device performed within the specified acceptance criteria. Specific numerical results for each criterion are not provided in the summary, only the conclusion that they meet the standards.

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

The document does not explicitly state the specific sample sizes used for testing each criterion. However, it indicates that the quality assurance is in compliance with ASTM D3578-00, which would dictate the sampling plans and statistical methods for determining compliance.

Data Provenance: Not explicitly stated, but the submission is from N.S. Uni-Gloves Sdn. Bhd. (Malaysia), suggesting the testing likely occurred there or was conducted on products manufactured there. It is a premarket notification for a medical device; thus, the data would be prospective for the purposes of demonstrating regulatory compliance.

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 to this type of device and study. The "ground truth" for examination gloves is established by objective physical and chemical testing against defined standards (ASTM D 3578-00 and FDA 1000 ml water test). It does not involve expert interpretation or subjective assessment of images or medical conditions.

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., medical imaging) where discordant expert opinions need resolution. For physical and chemical properties of gloves, objective measurements are taken, eliminating the need for adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This device is a patient examination glove, which does not involve human interpretation in its primary function for performance evaluation in this context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable to the UniGlove Lano-E Powder-Free Latex Examination Gloves. "Standalone" performance refers to an algorithm's ability to perform a task without human intervention, typically in AI/ML applications. A glove's performance is determined by its physical and chemical properties, not by an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation comprises objective measurements against established national and international standards. Specifically:

ASTM Standard D 3578 - 00: For physical properties (dimensions, tensile strength, elongation, pinhole AQL).
FDA 1000 ml water test: For water tightness/pinhole integrity.
EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989: Other international standards for quality assurance.
Specific material properties: Powder residue limit, protein content claim.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (examination glove) whose performance is evaluated against material and manufacturing standards. There is no "training set" in the context of machine learning or AI models for this device.

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

This information is not applicable as there is no training set for this device.