A patient examination glove is a disposable device intended for medical purposes, that 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.

Device Description

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for "Evergreen Non-Sterile Powder Free Latex Examination Gloves." This is a medical device, and the data presented describes its physical characteristics and biocompatibility, not an AI/ML-driven device. As such, several requested sections, particularly those pertaining to AI/ML specific studies (e.g., multi-reader multi-case studies, standalone algorithm performance, AI training/test sets, expert qualifications for AI ground truth), are not applicable to this document.

Below is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

TEST	Acceptance Criteria (ASTM D3578-95 & FDA)	Reported Device Performance (Evergreen Powder Free Latex Examination Gloves)
1. Watertight (1000ml)	G II (AQL=4.0%)	Pass G II (AQL=4.0%)
2. Length (mm) - XS	Min 230	240 mm minimum for all sizes
2. Length (mm) - S	Min 230	240 mm minimum for all sizes
2. Length (mm) - M	Min 230	240 mm minimum for all sizes
2. Length (mm) - L	Min 230	240 mm minimum for all sizes
2. Length (mm) - XL	-	240 mm minimum for all sizes
3. Palm Width (mm) - XS	-	73 - 78
3. Palm Width (mm) - S	80 ± 10	83 - 88
3. Palm Width (mm) - M	95 ± 10	93 - 98
3. Palm Width (mm) - L	111 ± 10	103 - 107
3. Palm Width (mm) - XL	-	-
4. Thickness (mm) - Finger (Single Layer)	min 0.08	0.10 minimum
4. Thickness (mm) - Palm (Single Layer)	min 0.08	0.10 minimum
5. Physical Properties - Before Ageing: Tensile Strength (Mpa)	min 14	23.8-25.2
5. Physical Properties - Before Ageing: Ultimate Elongation (%)	min 700	810-910
5. Physical Properties - After Ageing: Tensile Strength (Mpa)	min 14	19.8-20.7
5. Physical Properties - After Ageing: Ultimate Elongation (%)	min 500	750-870
6. Powder Content	-	below 2 mg/glove
7. Protein Content	-	below 50 microgram/gram
8. Biocompatibility	Pass (Primary Dermal Irritation Test & Guinea Pig Sensitization)	Pass

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for watertightness, length, etc.). It references "Performance data of gloves based on ASTM D3578-95 and FDA 1000ml watertight test." These standards typically define acceptable sampling plans for quality control, but the specific numbers used in this submission are not provided.

The data provenance is from YTY INDUSTRY (MANJUNG) SDN. BHD. in Malaysia. The studies appear to be prospective, laboratory-based quality control tests conducted on their produced gloves.

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

This question is not applicable. The "ground truth" for glove performance is established by objective physical and chemical testing methods according to specified ASTM and FDA standards, not by expert interpretation or consensus. No human experts are mentioned as establishing ground truth for these types of tests.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective measurements that require consensus. For physical and chemical tests of gloves, the results are objectively measured and compared against predefined criteria; there is no human adjudication process involved beyond validating the test methodology and results.

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 question is not applicable. The device is a medical glove, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study, human reader improvement with AI, or AI assistance is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. The device is a medical glove; there is no algorithm or AI component involved.

7. The Type of Ground Truth Used:

The ground truth is based on objective measurements and results from standardized physical, chemical, and biocompatibility tests as defined by:

ASTM D3578-95 (Standard Specification for Latex Examination Gloves)
FDA's 1000ml watertight test requirements
FDA's minimum powder residual content requirements
Biocompatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test) based on established protocols.

8. The Sample Size for the Training Set:

This question is not applicable. There is no AI/ML model for which a training set would be required. The manufacturing process of the gloves would involve quality control and process validation, but this is distinct from an AI training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no AI training set.

Summary

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K98 3608

Image /page/0/Picture/2 description: The image shows a black and white drawing of an object that appears to be a stylized representation of a stool or altar. It has a rectangular base with three vertical supports, and a crescent-shaped object rests on top of the supports. The overall design is simple and symmetrical, with a focus on geometric shapes.

YTY INDUSTRY (MANJUNG) SDN. BHD.

Company No : 380830-P) t 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188

ATTACHMENT N

SMDA 510 (K) SUMMARY 1.0 YTY Industry Sdn Bhd 2.0 Submitter Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan Perak Darul Ridzuan MALAYSIA 605-6792288 Tel 605-6791188 Fax 1. MR. MOH UNG NANG Name of Contact Person September 25, 1998 Date of Summary Prepared 3.0 Name of Device Trade Name : Evergreen Non-Sterile Powder Free Latex Examination Glove - Natural Color Evergreen Non-Sterile Powder Free Latex Examination Glove -Pink Evergreen Non-Sterile Powder Free Latex Examination Glove - Blue Exam Glove Common Name Patient Examination Glove Classification Name Identification of The Legally Marketed Devices 4.0 Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA requirements.

ﺎ

Description of The Device 5.0

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water leak test.

The Intended Use of Glove 6.0

A medical gloves 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.

Page 1 of 3

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K983608

7. Summary of Performance Data :

Performance data of gloves based on ASTM D3578-95 and FDA 1000ml watertight test.

TEST	ASTM D3578-95		EVERGREEN POWDER FREELATEX EXAMINATION GLOVES
1. Watertight (1000ml)	G II		Pass G II	AQL=4.0%
2. Length (mm)
Size	XS	Min 230	240 mm minimum forall sizes
	S	Min 230
	M	Min 230
	L	Min 230
	XL	-
3. Palm width (mm)
Size	XS	-	73 - 78
	S	$80 +- 10$	83 - 88
	M	$95 +- 10$	93 - 98
	L	$111 +- 10$	103 - 107
	XL	-	-
4. Thicknes (mm)(Single Layer)
Finger		min 0.08	0.10 minimum
Palm		min 0.08	0.10 minimum
5. Physical Properties.Before Ageing
Tensile Strength (Mpa)			23.8-25.2
Ultimete Elongation (%)	min 14min 700		810-910
After Ageing
Tensile Strength (Mpa)			19.8-20.7
Ultimete Elongation (%)	min 14min 500		750-870
6. Powder Content	-		below 2 mg/ glove
7. Protein content	-		below 50 microgram/ gram

ATTACHMENT N Page 2 Of 3

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The performance data of the glove as shown above meet the ASTM D3578-95 8. Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is < 50 mg/gram.

K483608

The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buchler) test. The gloves pass the Biocompatibility Tests.
1. Conclusion

We concluded that the Evergreen non-sterile, powder-free Latex Examination Gloves 111221 :

a ASTM D3578-95 Standard
-FDA pinhole requirements
FDA minimum powder residul content. -
Label Claim of maximum 50 micrograms per gram of glove or less for water -Extractable Protein.

Attachment N

3/3

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

5 1998 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

YTY Industry (Manjung) Sdn. Bhd. C/O Mr. E. J. Smith P.O. Box 4341 Crofton, Maryland 21114

Re : K983608 Trade Name: Evergreen Non-sterile, Latex Powder-Free Glove with Protein Content Labeling Claim (50 Micrograms or Less) (Pink, Blue and Natural) Requlatory Class: I Product Code: LYY September 25, 1998 Dated: October 14, 1998 Received:

Dear Mr. Smith:

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, Drug, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does 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 regulations.

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Page 2 - Mr. Smith

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Runner

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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510(k) Number (if known): Қ 98 3608

Evergreen Non-Sterile, Powder-Free, Protein Content Labeling Claim(50m/crcgrom Device Name: Examination Gloves: Natural, Blue and Pink or lešs LATEX

Indications for Use:

A patient examination glove is a disposable device intended for medical purposes, that is worn on A patient cxammation grove is a crevent 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

Qiin S. Lin
(Division Sign-Off)

(Concision of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Int 510(k) Number

u(k) Number K983608

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.