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

POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES

AI/ML Overview

Here is an analysis of the provided information regarding the acceptance criteria and the study for the device:

Device Name: POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
510(k) Number: K023590

1. Table of Acceptance Criteria and Reported Device Performance

TEST	Acceptance Criteria (ASTM D3578-01/AE2 & FDA 1000ML watertight test)	Reported Device Performance (EVERGREEN POWDERED LATEX EXAM. GLOVES)
1. Watertight (1000ml)	Multiple Normal GI, AQL = 2.5	Pass GI, AQL = 2.5
2. Length (mm)	Min 220 (XS, S), Min 230 (M, L)	240 mm minimum for all sizes
3. Palm width (mm)	70 ± 10 (XS), 80 ± 10 (S), 95 ± 10 (M), 111 ± 10 (L)	73 - 78 (XS), 83 - 88 (S), 93 - 98 (M), 103 - 107 (L)
4. Thickness (mm) (Single Layer)
Finger	Min 0.08	Min 0.10
Palm	Min 0.08	Min 0.10
5. Physical Properties Before Aging
Tensile Strength (MPa)	Min 18	23 - 27
Ultimate Elongation (%)	Min 650	820 - 880
Stress at 500% Elongation	Max 5.5	2.9 - 3.6
6. Physical Properties After Aging
Tensile Strength (MPa)	Min 14	20 - 27
Ultimate Elongation (%)	Min 500	780 - 860
7. Powder Content	10mg per square decimeter max	Below 10 mg per square decimeter
8. Bio-Compatibility	Not specified (implied by listed tests)	Dermal Sensitization, Primary Skin Irritation (Successful Results)

Study Information

The provided document describes performance testing conducted to demonstrate that the device meets established standards.

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

Sample Size: Not explicitly stated for each specific test, but the "Watertight (1000ml)" test mentions "Multiple Normal GI AQL = 2.5," which refers to an Acceptance Quality Limit sampling plan. This implies a statistical sampling method was used based on the AQL, but the exact number of units sampled is not provided.
Data Provenance: The manufacturer is YTY INDUSTRY (MANJUNG) SDN BHD, suggesting the data originates from testing conducted by or for this Malaysian company. The document does not specify if the data is retrospective or prospective.

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 study involves objective physical and chemical performance tests of latex gloves, not diagnostic interpretation or clinical assessment by experts. The "ground truth" is defined by the technical specifications and standard requirements (e.g., watertight, length, tensile strength).

4. Adjudication method for the test set:

This information is not applicable for these types of performance tests. Adjudication methods are typically used when there are subjective interpretations or conflicting expert opinions, which is not the case for physical property measurements or watertight tests.

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. The device is Latex Exam Gloves, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance metrics are irrelevant.

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

This information is not applicable. The device is a physical product (latex gloves), not an algorithm or software.

7. The type of ground truth used:

The ground truth is based on objective technical standards and measurements. Specifically, the listed ASTM standards (ASTM D3578-01/AE2, ASTM D5712-99, ASTM D6124-01, ASTM D5151-99), FDA watertight test (1000ML), ISO 2859, and established bio-compatibility tests (Dermal Sensitization, Primary Skin Irritation). These standards define the acceptable range or threshold for each performance characteristic.

8. The sample size for the training set:

This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

This information is not applicable for the same reason as point 8.

Summary

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8 2002 NOV

	K023590
510(k) SUMMARY
Submitted For:	YTY INDUSTRY (MANJUNG) SDN BHD
Submitted By:	TUCKER & ASSOCIATESOfficial Correspondent for YTY INDUSTRY(MANJUNG) SDN BHDJANNA 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:	23 October 2002
Device Name:	POWDERED NATURAL AND/OR COLOREDLATEX EXAM GLOVESClass I Device, 80LYY
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.
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. It is SubstantiallyEquivlalent to the devices manufactured by Shield GlovesManufacturer (M) K943807, and YTY Industry (Manjung)SDN BHD, K974191 (natural color).

EXHIBIT N
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7.0 Summary of Performance Data:

Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.

TEST	ASTM D3578-01/AE2	EVERGREEN POWDEREDLATEX EXAM. GLOVES
1. Watertight (1000ml)	Multiple NormalGIAQL = 2.5	Pass GIAQL = 2.5
2. Length (mm)SizeXSSMLXL	Min 220Min 220Min 230Min 230-	240 mm minimum for all sizes
3. Palm width (mm)SizeXSSMLXL	70 ± 1080 ± 1095 ± 10111 ± 10-	73 - 7883 - 8893 - 98103 - 107
4. Thickness (mm)(Single Layer)
FingerPalm	Min 0.08Min 0.08	Min 0.10Min 0.10
5. Physical PropertiesBefore AgingTensile Strength (MPa)	Min 18	23 - 27
Ultimate Elongation (%)	Min 650	820 - 880
Stress at 500% Elongation	Max 5.5	2.9-3.6
After AgingTensile Strength (MPa)	Min 14	20 - 27
Ultimate Elongation (%)	Min 500	780 - 860
6. Powder Content	10mg per square decimeter max	Below 10 mg per square decimeter

EXHIBIT N
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Page 2 of 3

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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 5712-99 ASTM D 3578-01aE2 ASTM D 6124-01 ASTM D 5151-99 ISO 2859

Bio-Compatibility: Dermal Sensitization Primary Skin Irritation

Conclusion:

This device is substantially equivalent to the devices approved as K943807 and K974191.

EXHIBIT N
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 NOV

YTY Industry (Manjung) Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550

Re: K023590

Trade/Device Name: Powdered, Natural, Pink and Blue Colored Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 23, 2002 Received: October 25, 2002

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 (OS) 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,

Susan Dunn

Timothy A. Ulatowski 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: YTY INDUSTRY (MANJUNG) SDN. BHD.

510(k) NUMBER: KO23590

POWDERED, NATURAL AND/OR (Pink, Buce) DEVICE NAME: COLORED LATEX EXAM GLOVES

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)

Prescription Use (Per 21 CFR 801

Over-The-Counter Use

(Optional Format 1-2-96)

Qlin S. Lin

sion Sign-Off) on of Anesthesiology, General Hospital, on Control. Dental Device

EXHIBIT B
Page 2 of 103

510(k) Number: K 923080

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.