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.

Summary

{0}------------------------------------------------

2005 APR 8 -

510(k) Number: K050765

Submission Applicant:

N.S. Uni-Gloves Sdn. Bhd. Lot 3 & 4/4510 Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Telephone No. 60-6-677-2751/2 Malaysia Fax No. 60-6-677-2755

Device Listing No. B 034622 Registration No. 8040880 K050765 510(k) Number:

Official Correspondent in the United States:

Kenneth J. Stanton, President UG Healthcare (USA) Inc. 2420 Carson St., Suite 125 Torrance, CA 90501

Telephone No .: (310) 328-7981 Fax No.: (310) 328-7829

Submitted: March 15, 2005

A. Description of the Device Trade Name: Lano-E Powder-Free Nitrile Examination Glove Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A

Intended Use of the Device: 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.

SUMMARY PREMARKET 510(k) NOTIFICATION For Lano-E Powder-Free Nitrile Examination Gloves K050765 510(k) Number: March 23, 2005

{1}------------------------------------------------

Summary of Technological Characteristics:

Powder Residue: Maximum 2mg/glove Material: Nitrile Cuff: Beaded Cuff: Quality Assurance: In compliance with ASTM D6319-00 Rev A, EN 455-3 : 2000, EN 455-2 : 2000, EN 455-1 : 2000, ISO 2859-1:1999 and manufactured under ISO9001:2000

Inspection Parameters:

Criteria	Inspection Level	AQL
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:

Dimensions:
Overall Length:	240 mm minimum
Width:	95 mm minimum (for medium glove)
Palm Thickness:	0.10 to 0.15 mm (at center of palm)
Finger Thickness:	0.10 to 0.17 mm (at 15mm from tip of center finger)
Cuff Thickness:	0.10 to 0.15 mm (at 40mm from the beaded end)

BEFORE AGING

AFTER AGING

Tensile Strength:	14.0. Mpa minimum
Ultimate Elongation:	700% minimum
Pinhole AQL	1.5 minimum

14.0 Mpa minimum 500% minimum 1.5 minimum

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

Sizes: XXS - XL

Conclusion: 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.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

Public Health Service

2005 APR 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

N.S. Uni-Gloves Sdn. Bhd. C/O Mr. Kenneth J. Stanton President UG Healthcare (USA) Incorporated 2420 Carson Street Suite 125 Torrance, California 90501

Re: K050765

Trade/Device Name: Lano-E, Powder Free, Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 4, 2005 Received: April 5, 2005

Dear Mr. Stanton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Stanton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Quls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

Page - 5

510(k) Number (if known): __K050765

Device Name: Lano-E, Powder Free, Nitrile Examination Gloves

Indications For Use The Lano-E, Powder Free, Nitrile Examination Gloves is a disposable r the Land-E, I owder Froo, Nittio see that is worn on the examiner's hand to prevent contamination between patient and examiner

Prescription Use (Part 21 CFR 801 Subpart D)

: :

. "

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shiela A. Murphy, MD 4/8/05

insion Sion-Off) Asion of Anesthesiology, General Hospital, Intection Control. Dental Devices

Labels	Values
Number	1650/15

Regulation Number and Section

§ 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.