A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water Leak Test.

AI/ML Overview

The provided document describes the performance data for "Cashmere Powder Free Latex Examination Gloves" based on ASTM D3578-01 and FDA 1000 ml watertight test.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (ASTM D3578-01)	Reported Device Performance (CASHMERE POWDER FREE LATEX EXAM GLOVES)
Watertight (1000 ml)	AQL=4.0%	Pass GI AQL=4.0%
Length (mm)	Min 230 (for all sizes S, M, L)	240 mm minimum for all sizes
Palm width (mm) - Size S	80 +/- 10	82 - 88
Palm width (mm) - Size M	95 +/- 10	92 - 98
Palm width (mm) - Size L	111 +/- 10	102 - 108
Thickness (mm) (Single Layer) - Finger	Min 0.08	0.10 minimum
Thickness (mm) (Single Layer) - Palm	Min 0.08	0.10 minimum
Physical Properties - Before Aging
Tensile Strength (Mpa)	Min 14	18.7*
Ultimate Elongation (%)	Min 650	956*
Physical Properties - After Aging
Tensile Strength (Mpa)	Min 14	18.3*
Ultimate Elongation (%)	Min 500	938*
Powder Content	(Implied FDA Requirement: Below 2 mg/glove)	Below 2 mg / glove
Protein Content	(Implied FDA Requirement: Below 50 ug/gram)	Below 50 microgram / gram

* The document states these are "The average result taken from Attachment B2," which is not included in the provided text.

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

The document does not explicitly state the sample sizes used for each test. However, it mentions "AQL=4.0%" for the watertight test, which refers to Acceptable Quality Level, a sampling standard. The data provenance is Malaysia and the study appears to be a prospective testing of manufactured gloves.

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 physical device performance test based on established ASTM standards, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against predefined 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 not an AI-assisted diagnostic device.

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

This is a standalone device in the sense that its performance is measured directly against physical and chemical standards, without human interaction with an algorithm.

7. The type of ground truth used

The ground truth is established by the specified ASTM D3578-01 Standard and FDA requirements for watertightness, powder content, and protein content. These are objective, quantitative standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set in that context. The "training" for the device would be the manufacturing process itself, and the goal is to consistently produce gloves that meet the specifications.

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

Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm. For the manufacturing process, the "ground truth" for the processes (making the gloves) is the ability to consistently achieve the stated performance criteria for the final product.

Summary

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SEP 2 6 2002

SEAL POLYMER INDUSTRIES SDN. BHD.

Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia.

Tel: 605-3223 200 Fax: 605- 3222 300

E-mail: spoly@po.jaring.my

K022792

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 CHOOI FONG
	Date of Summary Prepared	August 8, 2002

3.0	Name of Device
	Trade Name	Cashmere Powder Free Latex Examination Gloves E protein labeling claim

Exam Glove

Patient Examination Glove

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the

Identification of The Legally Marketed Devices

requirements of ASTM Standard D3578-01 and FDA requirements.

Common Name

4.0

Classification Name

5.0 Description of The Device

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water Leak Test.

The Intended Use of Glove 6.0

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Page 1 of 3 ATTACHMENT M

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SEAL POLYMER INDUSTRIES SDN. BHD.

Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my

7. Summary of Performance Data :

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

TEST	ASTM D3578-01	CASHMERE POWDER FREE LATEX EXAM GLOVES
1. Watertight (1000 ml)	GIAQL=4.0%	Pass GIAQL=4.0%
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	-	75 - 78
S	80 +/- 10	82 - 88
M	95 +/- 10	92 - 98
L	111 +/- 10	102 - 108
XL	-	111 - 115
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	18.7*
Ultimate Elongation (%)	Min 650	956*
After AgingTensile Strength (Mpa)	Min 14	18.3*
Ultimate Elongation (%)	Min 500	938*
6. Powder Content	-	Below 2 mg / glove
7. Protein Content	-	Below 50 microgram / gram

· The average result taken from Attachment B2.

Page 2 of 3 ATTACHMENT M

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SEAL POLYMER INDUSTRIES SDN. BHD.

Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: 605-3223 200 Fax: 605- 3222 300 E-mail: spoly@po.jaring.my

1. The performance data of the glove as showed above meet the ASTM D3578-01 Standard and FDA's requirement. Powder content is below 2 mg per glove that meets the FDA Requirements.
1. The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
1. Conclusion

We concluded that the Cashmere Powder Free Latex Examination Gloves meet:

-ASTM D3578-01 Standard
FDA pinhole requirements -
-FDA minimum powder residual content

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2002

Mr. Chun Chooi Fong Quality Assurance Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat Kawasan Perindustrain Bukit Merah, 31500 Lahat, Perak, MALAYSIA

Re: K022792

Trade/Device Name: Cashmere Non-Sterile, Powder Free Latex Examination Gloves (Polymer Coated Online Chlorinated) Contains 50 Micrograms or Less Of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYY Dated: August 13, 2002 Received: August 22, 2002

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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Page 2 - Mr. Fong

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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INDICATIONS FOR USE STATEMENT

: Seal Polymer Industries Sdn. Bhd. Applicant

K022792 510(K) Number :

: Cashmere Non-Sterile, Powder Free Latex Examination Gloves (Polymer Device Name Coated Online Chlorinated) Contains 50 mcgin or less et Tefal Coated Online Chiomatod) Cerritoris per grain

Indication For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

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

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

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

St. Paul's tiv Ulin

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: KC12792

Page 5

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.