A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Class I Latex Patient Examination Glove 80 LYL, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-95 and FDA Water Leak Test.

AI/ML Overview

The provided text describes the acceptance criteria and the results of tests performed on "Evergreen Non-Sterile Powdered Latex Examination Gloves" to demonstrate their compliance with established standards.

Here's the information extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Specific Test / Characteristic	Acceptance Criteria (ASTM D3578-95)	Reported Device Performance (Evergreen Gloves)
Dimensions	Minimum Length (all sizes)	230 mm minimum	240 mm minimum
	Thickness – Finger	0.08 mm minimum	0.10 mm minimum
	Thickness – Palm	0.08 mm minimum	0.10 mm minimum
	X Small Width	70 mm +/- 10 mm	73 - 78 mm
	Small Width	80 mm +/- 10 mm	83 - 88 mm
	Medium Width	90 mm +/- 10 mm	93 - 98 mm
	Large Width	100 mm +/- 10 mm	103 - 107 mm
Physical Properties	Tensile Strength (Before Aging)	14.0 Mpa	26.7 Mpa
	Ultimate Elongation (Before Aging)	700%	840%
	Tensile Strength (After Aging)	14.0 Mpa	21.8 Mpa
	Ultimate Elongation (After Aging)	500%	820%
Integrity	Water Tight Test (FDA Water Leak Test Method)	AQL 4.0% General Inspection II multiple sampling plan (specific pass/fail based on sample size and defects)	Passed (e.g., 1 unit leak in 80 for Large/Medium, 0 for Small)
Biocompatibility	Primary Dermal Irritation Test	(Implicitly passed for acceptance)	Passed
	Skin Sensitization Study	(Implicitly passed for acceptance)	Passed
Protein Content	Water Soluble Protein Test (ASTM D5712)	No Label Claim on Protein Level	209 ug/g (against OVBM) (for one batch)

2. Sample Sizes Used for the Test Set and Data Provenance:

Water Tight Test:
- Sample Size: 80 pieces of gloves per batch were tested.
- Data Provenance: The testing was performed by YTY Industry (Manjung) Sdn Bhd (Malaysia). It appears to be retrospective testing of produced batches.
Dimensional, Tensile Strength, and Elongation Tests:
- The document does not explicitly state the sample size for these tests. It reports specific values for "YTY's Gloves" which implies samples were taken and tested, but the number of units is not provided.
- Data Provenance: Presumably from internal testing conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia). Also appears retrospective.
Biocompatibility Tests:
- The document does not state the sample size.
- Data Provenance: Not explicitly stated, but typically done by third-party labs. The document only states "The gloves pass the Biocompatibility Tests."
Water Soluble Protein Test:
- Sample Size: Not explicitly stated, but results are given for one "Batch No. Production Date."
- Data Provenance: Presumably from internal testing conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia).

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

Not applicable. This document describes performance testing against established industry standards (ASTM D3578-95, FDA Water Leak Test, ASTM D5712, etc.) for physical and chemical properties of gloves. The "ground truth" is defined by these objective engineering and regulatory standards, not by expert consensus on subjective observations.

4. Adjudication Method for the Test Set:

None. The tests described are objective measurements (dimensions, strength, elongation) or standardized pass/fail criteria (water leak, biocompatibility). There is no "adjudication" in the sense of multiple human reviewers resolving discrepancies in a subjective assessment. The water leak test uses an AQL (Acceptable Quality Level) sampling plan, which is a statistical method for determining acceptance based on defects, not expert adjudication.

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 document is for the premarket approval of a medical device (latex examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI comparison is relevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used:

The ground truth is based on established engineering and material science standards and regulatory requirements. Specifically:
- ASTM D3578-95 Standard (for dimensions, tensile strength, ultimate elongation).
- FDA Water Leak Test requirements (for integrity/holes).
- ASTM D5151-90 Test method for Detection of Holes in Medical Gloves.
- Biocompatibility test standards (Primary Dermal Irritation Test and Skin Sensitization Study, though specific standard numbers are not given here).
- ASTM D5712 standards (for Water Soluble Protein Test).

8. The sample size for the training set:

Not applicable. Since this is not an AI/machine learning model, there is no "training set." The glove manufacturing process is controlled to meet these pre-defined specifications through quality control and process validation.

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

Not applicable. As there is no training set for an AI model, this question is not relevant. The "ground truth" for the product's performance is the adherence to the published ASTM and FDA standards.

Summary

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Image /page/0/Picture/1 description: The image shows a black and white drawing of a symbol. The symbol is symmetrical and features a horizontal curved line at the top. Below the curved line is a rectangular shape with two vertical lines on either side. The symbol has a simple and minimalist design.

YTY INDUSTRY (MANJUNG) SDN. BHD.

(Company No : 380830-P) (Company No : 00000 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Eol 1422-1424, Bula 166ing Line), 6792443 & 6792445 Fax : 05-6791188

APPENDIX H

DEC 2 4 1997

510 (K) SUMMARY

2	SumitterYTY Industry (Manjung) Sdn BhdLot 1422-1424, Batu 10 Lekir,32020 SitiawanPerak Darul Ridzuan,Malaysia.
Tel	605-6792288
Fax	605-6791188

Name of contact Paerson 1. MR. MOH UNG NANG

Date of Summary Prepared

September 20, 1997

3 Name Of Device

Trade Name	Evergreen Non-Sterile Powdered Latex Examination Gloves
Common Name	Exam Gloves
Classification Name	Patient Examination Glove

4 ldentification of The Legally Marketed Devices

Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirements of ASTM Standard D3578-95

5 Description Of The Device

Class I Latex Patient Examination Glove 80 LYL, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-95 and FDA Water Leak Test.

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The Intended Use Of GLove 6.0

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

7.0 Technoligical Chracteristic of Device.

Dimensions A.

DIMENSION	ASTM D 3578-95	EVERGREEN GLOVE
X Small	70 mm +/- 10 mm	73 - 78 mm
Small	80 mm +/- 10 mm	83 - 88 mm
Medium	90 mm +/- 10 mm	93 - 98 mm
Large	100 mm +/- 10 mm	103 - 107 mm
Length	230 mm minimumfor all sizes	240 mm minimumfor all sizes
Thickness – finger	0.08 mm minimum	0.10 mm minimum
Palm	0.08 mm minimum	0.10 mm minimum

TEST	TENSILE STRENGTH		ULTIMATE ELONGATION
	ASTM	YTY'S	ASTM	YTY'S
	D3578-95	Gloves	D 3578-95	Gloves
BEFORE AGING	14.0 Mpa.	26.7 Mpa	700%	840%
AFTER AGING7 days at 70	14.0 Mpa.	21.8 Mpa	500%	820%

Our gloves meets all the specifications of the ASTM D3578-95 Standards.

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C. WATER TIGHT TEST

FDA water leak test method is used to test 80 pieces of gloves at AQL 4.0% General Inspection II multiple sampling plan. The results are as follows:

Batch	Size	Sample Size	Unit Leak	Disposition
70881981	Large	80	1	Accepted
70881962	Medium	80	1	Accepted
70882003	Small	80	0	Accepted

The test meets the FDA Water Leak Test Requirements.

BIOCOMPATIBILITY ப்

The test consists of Primary Dermal Irritation Test and Skin Sensitization Study.

The gloves pass the the Biocompatibility Tests.

E. Water Soluble Protein Test by ASTM D5712 standards.

Batch No. Production Date	Protein Content ug/g(against OVBM)
1. R123-5L5M(03/09/97) Medium	209

There is no Label Claim on Protein Level.

Conclusion.

We concluded that Evergreen Non-Strile, Latex Examination Gloves meet:

ASTM D3578-95 --Standard.
-FDA Water Leak Test requirements.
ASTM D5151 -90 Test method for Detection of Holes in Medical Gloves. -

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by three intertwined human profiles. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 1997

Mr. Leonard Frier ·President YTY Industry Sdn. Bhd. C/O MET Laboratories 914 West Patapsco Avenue Baltimore, Maryland 21230-3432

K974191 Re : Everqreen Non-Sterile Powdered Latex Trade Name: Examination Glove Requlatory Class: I Product Code: LYY December 18, 1997 Dated: Received: December 19, 1997

Dear Mr. Frier:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Frier

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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INDICATIONS FOR USE STATEMENT

Applicant : YTY INDUSTRY (MANJUNG ) SDN BHD

510K Number : Poli 22 personal program and the production of the comments of the comments of the comments of the comments of the country of the country of the country of the country of the Device Name : Evergreen Latex Examination Gloves ર

Indications For Use :

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number	K974191
---------------	---------

Prescription Use	OR	Over-The-Counter
Per 21 CFR 801.109

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.