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.

Device Description

POWDER-FREE BLUE VINYL EXAM GLOVES

AI/ML Overview

The provided document is for a 510(k) premarket notification for "POWDER-FREE BLUE VINYL EXAM GLOVES". This is a medical device submission for physical examination gloves, and the evaluation criteria and studies are related to the performance characteristics of these gloves, not to an AI/Software as a Medical Device (SaMD).

Therefore, many of the requested fields, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Number of experts used to establish ground truth," and "Effect size of how much human readers improve with AI vs. without AI assistance," are not applicable to this type of device.

Here's a breakdown of the available information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard/Test)	Reported Device Performance
ASTM D 5250-00E4	Met or exceeded
ASTM D 5151-99	Met or exceeded
ASTM D 6124-01	Met or exceeded
ISO 2859	Met or exceeded
MIL Std 105E	Met or exceeded
Bio-Compatibility: Dermal Sensitization	Met or exceeded
Bio-Compatibility: Primary Skin Irritation	Met or exceeded
Bio-Burden (Procedure Method 8315)	Met or exceeded

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in the provided text. The standards (e.g., ASTM, ISO, MIL Std) typically outline specific sampling plans, but the document only states that the device "met or exceeded" them.
Data Provenance: Not explicitly stated. For physical device testing, the "country of origin of the data" is generally less relevant than the standards followed. The testing would have been conducted by the manufacturer or a contracted lab to demonstrate compliance with the listed standards. It is implied to be prospective testing for the specific device being submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For physical device testing like examination gloves, "ground truth" is established through standardized physical, chemical, and biological tests, not by expert consensus in the diagnostic sense. The "experts" would be the scientists and technicians performing the tests according to the specified ASTM, ISO, and other standards.

4. Adjudication method for the test set:

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for interpreting diagnostic images or clinical scenarios where human judgment is involved. For physical tests of gloves, results are typically objective measurements against predefined thresholds in the 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:

Not Applicable. This is an AI/SaMD related study type and does not apply to examination gloves.

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

Not Applicable. This is an AI/SaMD related evaluation and does not apply to examination gloves.

7. The type of ground truth used:

For examination gloves, the "ground truth" is defined by the performance specifications and acceptance criteria outlined in the referenced industry standards (ASTM D 5250-00E4, ASTM D 5151-99, ASTM D 6124-01, ISO 2859, MIL Std 105E) and biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Bio-Burden). These standards define the acceptable levels for properties such as strength, barrier integrity (pinholes), biocompatibility, and perhaps dimensions.

8. The sample size for the training set:

Not Applicable. Physical devices like gloves do not have "training sets" in the context of machine learning. The manufacturing process is controlled and validated, and batches are tested to ensure ongoing quality.

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

Not Applicable. As there is no training set for this type of device, this question is irrelevant.

Summary

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K041945

AUG 2 0 2004

510(k) SUMMARY

Submitted For:	GLORMED INTERNATIONAL, INC.
Submitted By:	TUCKER & ASSOCIATESOfficial Correspondent for GLORMED INT'L., INC.JANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550
Phone:	775-342-2612
Fax:	775-342-2613
E-Mail:	Tuckerjan@aol.com
Date of Submission:	14 July 2004
Device Name:	POWDER-FREE BLUE VINYL EXAM GLOVESClass I Device, 80LYZ
Proprietary Name:	(Multiple Private Labels)
Labels/Labeling:	This device will be marketed to healthcare professionals atDentist and Doctor Offices, Laboratories, Clinics andHospitals through its distributors for the intended use of
exam	gloves.
Intended Use:	A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's handor finger to prevent contamination between patient andexaminer.
Substantial Equivalence:	Both in its intended use and/or physicalcharacteristics, this device is equivalent to devicescurrently marketed by U.S. companies. Except for color,thesegloves are comparable to gloves approved as K002340 andK021353

EXHIBIT L
Page 48 of 49

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510k) Summary page 2.

Test Results (Means and/or Successful Results:

This device has met or exceeded the following standards and/or tests:

ASTM D 5250-00E4 ASTM D 5151-99 ASTM D 6124-01 ISO 2859 MIL Std 105E Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Bio-Burden (Procedure Method 8315)

Except for color, this device is comparable to gloves approved in Conclusion: K002340 and K021353.

EXHIBIT L
Page 49 of 49

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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

AUG 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Glormed International, Incorporated C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks. Nevada 89434-9550

Re: K041945

Trade/Device Name: Powder-Free Blue Vinyl Exam Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 14, 2004 Received: July 20, 2004

Dear Ms. Tucker:

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.

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Page 2 - Ms. Tucker

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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

hiu 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

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INDICATIONS FOR USE

APPLICANT: GLORMED INTERNATIONAL, INC.

510(k) NUMBER: K041945

POWDER-FREE BLUE VINYL EXAM DEVICE NAME: GLOVES

A patient examination glove is a disposable device intended for medical purposes that is A patient examination glove is a disposuole do not ansamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Muly

General Hospital,

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number: K041945

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.