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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "UC Healthcare (USA) Inc.". The logo consists of the letters "UC" stacked on top of each other on the left side of the image. To the right of the letters is the text "Healthcare (USA) Inc."

2420 Carson Street · Suite 125 · Torrance, CA 90501

Local: 310-328-7981 Toll Free: 800-328-7981 Fax: 310-328-7829

JAN 2 2 2002

SUMMARY PREMARKET 510(k) NOTIFICATION For UniGlove Lano-E Powder-Free Latex Examination Gloves 510(k) Number: Kol3163

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

Registration No. 8040880 Devise Listing No. B 034616 510(k) Number:

Official Correspondent in the United States:

Robert D. Vander Leek, President UG Healthcare (USA) Inc. 2420 Carson St., Suite 125 Torrance, CA 90501

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

Submitted: September 14, 2001

A. Description of the Device

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.

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SUMMARY PREMARKET 510(k) NOTIFICATION For UniGlove Lano-E Powder-Free Latex Examination Gloves 510(k) Number:

September 14, 2001

Summary of Technological Characteristics:

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.

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:	0.15 to 0.20 mm (at center of palm)
Finger Thickness:	0.17 to 0.25 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

	BEFORE AGING
Tensile Strength:	21. Mpa minimum
Ultimate Elongation:	700% minimum
Pinhole AQL	1.5 minimum

16.0 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

Conclusion: The UniGlove Powder-Free Latex Examination Glove meets the physical property requirements of ASTM D 3578-00 and the FDA 1000 ml water test both before and after aging.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2002

N.S. Uni-Gloves Sdn. Bhd. C/O Robert D. Vander Leek UG Healthcare (USA), Incorporated 2420 Carson Street, Suite 125 Torrence, California 90501

Re: K013163

Trade/Device Name: UniGlove Lano-E Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 8, 2002 Received: January 9, 2002

Dear Mr. Leek:

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 Amendie entiments, 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 approvisions 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 (1 Mr.), it nay ob days of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Leek

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

L. Alatort

Timothy latowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_KO13163

UNIGLOVE LANO-E POWDER-FREE EXAMINATION GLOVES Device Name:_ WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

Indications For 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 patient and examiner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)

Chin S. Lin

Civision Sign-Off) vision of Dental, Infection Control, i Ceneral Hospita i; Number

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.