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.

Device Description

Class 1 Powdered Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA Water Leak Test.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for "Cashmere Non-Sterile, Powdered Latex Examination Gloves". Here's the information requested, extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

TEST	Acceptance Criteria (based on ASTM D3578-99 and FDA 1000 ml watertight test)	Reported Device Performance (CASHMERE LIGHTLY POWDERED LATEX EXAM GLOVES)
1. Watertight (1000 ml)	GI AQL=2.5%	Pass GI AQL=2.5%
2. Length (mm) - All Sizes	Min 230	240 mm minimum for all sizes
3. Palm width (mm) - Size XS	-	<80
3. Palm width (mm) - Size S	80 +/- 10	82 - 88
3. Palm width (mm) - Size M	95 +/- 10	92 - 98
3. Palm width (mm) - Size L	111 +/- 10	102 - 108
3. Palm width (mm) - Size XL	-	>110
4. Thickness (mm) (Single Layer) - Finger	Min 0.08	0.10 minimum
4. Thickness (mm) (Single Layer) - Palm	Min 0.08	0.10 minimum
5. Physical Properties (Before Aging) - Tensile Strength (Mpa)	Min 14	27.1*
5. Physical Properties (Before Aging) - Ultimate Elongation (%)	Min 700	917.5*
5. Physical Properties (After Aging) - Tensile Strength (Mpa)	Min 14	24.9*
5. Physical Properties (After Aging) - Ultimate Elongation (%)	Min 500	880*
6. Powder Content	Below 200 mg / glove (FDA requirement)	Below 200 mg / glove
7. Protein Content	Below 200 microgram / gram (As per the device name's claim)	Below 200 microgram / gram
8. Biocompatibility Test	Pass Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test	Pass Biocompatibility Tests

Note: The document states these figures were the average among the eight tested samples.

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

Sample Size for Test Set: The document explicitly mentions "eight tested samples" for the physical properties (tensile strength and ultimate elongation). For watertightness, it references "GI AQL=2.5%", which implies a sampling plan defined by ASTM D3578-99 and FDA 1000 ml watertight test, but the specific number of gloves tested is not provided in this summary.
Data Provenance: The study appears to be retrospective, as it's a summary of performance data collected to demonstrate compliance with existing standards (ASTM D3578-99 and FDA requirements). The manufacturer is Seal Polymer Industries Sdn. Bhd., located in Lahat, Perak, Malaysia.

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

Not applicable. This is a performance claim for a physical device based on standardized tests, not an AI/diagnostic device requiring expert ground truth establishment for medical image interpretation or similar. The "ground truth" is established by the specifications in ASTM D3578-99 and FDA requirements.

4. Adjudication method for the test set

Not applicable. As this involves physical testing against established standards, adjudication by experts for discordant results is not mentioned or typically relevant. The results are objective measurements or pass/fail criteria.

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 describes a medical glove, not an AI-assisted diagnostic device.

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

Not applicable. This document describes a medical glove, not an algorithm.

7. The type of ground truth used

The ground truth for this device's performance is based on established industry standards and regulatory requirements:

ASTM D3578-99 Standard
FDA 1000 ml watertight test requirements
FDA minimum powder residual content requirements
Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test).

8. The sample size for the training set

Not applicable. This is a medical glove, not an AI device that requires a training set.

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

Not applicable. This is a medical glove, not an AI device that requires a training set.

Summary

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SEAL POLYMER INDUSTRIES S )N. BHD. Lot 72706, Jalan Lahat Krwasan Perindustrian Bukit Merah

31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 32 : 2300

1.0		SMDA 510 (K) SUMMARY
2.0	Submitter	SEAL POLYMER INDUSTRIES SDN BHDLot 72706, Jalan LahatKawasan Perindustrian Bukit Merah31500 Lahat, Perak, Malaysia
	Tel	(60 5) 322 3200
	Fax	(60 5) 322 2300
	Name of Contact Person	Ms. CHUN CHOO: FONG
	Date of Summary Prepared	November 15, 2001
3.0	Name of Device
	Trade Name	Cashmere Non-Sterile, PowderedLatex Examination Gloves
	Common Name	Exam Glove
	Classification Name	Powdered Patient ExaminationGlove

Identification of the Legally Marketed Devices 4.0

Class 1 Powdered Latex Patient Examination Glove 30 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA requirements.

રું.0 Description of The Device

Class 1 Powdered Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA Water Leak Test.

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.

Page 1 of 3 ATTACHMENT I

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SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

Summary of Performance Data: 7.

Performance data of gloves based on ASTM D3578-99 and FDA 1000 ml watertight test.

TEST	ASTM D3578-99	CASHMERE LIGHTLY POWDERED LATEX EXAM GLOVES
1. Watertight (1000 ml)	GIAQL=2.5%	Pass GIAQL=2.5%
2. Length (mm)Size XS	Min 230	240 mm minimum for all sizes
S	Min 230
M	Min 230
L	Min 230
XL	Min 230
3. Palm width (mm)Size XS	-	<80
S	80 +/- 10	82 - 88
M	95 +/- 10	92 - 98
L	111 +/- 10	102 - 108
XL	-	>110
4. Thickness (mm)(Single Layer)Finger	Min 0.08	0.10 minimum
Palm	Min 0.08	0.10 minimum
5. Physical PropertiesBefore AgingTensile Strength (Mpa)	Min 14	27.1*
Ultimate Elongation (%)	Min 700	917.5*
After AgingTensile Strength (Mpa)	Min 14	24.9*
Ultimate Elongation (%)	Min 500	880*
6. Powder Content	-	Below 200 mg / glove
7. Protein Content	-	Below 200 microgram / gram

These figures were the average among the eight tested samples. Please refer to Attachment B2.

Page 2 of 3 ATTACHMENT I

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SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

The performance data of the glove as showed above meet the ASTM D3578-99 8. Standard and FDA's requirement. Powder content is below 200 mg per glove, which meet the FDA Requirements.
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 Cashmere Non-Sterile, Lightly Powdered Latex Examination Gloves meet:

ASTM D3578-99 Standard -
FDA pinhole requirements =
. " FDA minimum powder residual content

Page 3 of 3 ATTACHMENT I

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2002

Mr. Chun C. Fong Seal Polymer Industries Sdn. Bhd. Lt 72706, Jalan Lahat, Kawasan Perindustrain Bukit Merah Lahat, Ipoh, Perak, MALAYSIA

Re: K014055

Trade/Device Name: Non-Sterile Powdered Latex Examination Gloves with a Protein Labeling Claim ( 200 Micrograms orLess ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 4, 2001 Received: December 10, 2001

Dear Mr. Fong:

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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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,

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

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INDICATIONS FOR USE STATEMENT

KO14055

: Seal Polymer Industries Sdn. Bhd. Applicant

S 10(K) Number

: Cashmere Non-Sterile, Powdered Latex Examination Device Name Gloves With Protein Labeling Claim (200 micrograms or less)

Indication 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 parients' body, fluids, waste ﺃﺧﺬ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﺘﻲ

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODC)

Prescription Use: ... ... ... ... ... ... ... ... .. Per 21 CFR 80.109

Over-The-Counter .................. X

Olin S. Lin
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 1 ((k) Number _

Page 4

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.