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 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for "Cashmere Polymer Coated Powder Free Nitrile Examination Gloves".

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (ASTM D6319-00aE3 / FDA)	Reported Device Performance (POLYMER COATED POWDER FREE NITRILE EXAM GLOVES)
Watertight (1000 ml)	AQL=2.5% Pass G I (ASTM D6319-00aE3)	AQL=2.5% Pass GI
Length (mm)
Min Length (all sizes)	Min 230	240 mm minimum for all sizes
Palm Width (mm)
Size XS	- (no specific ASTM value)	<80 mm
Size S	80 +/- 10	85 +/- 3 mm
Size M	95 +/- 10	95 +/- 3 mm
Size L	111 +/- 10	105 +/- 3 mm
Size XL	- (no specific ASTM value)	111 +/- 3 mm
Size XXL	- (no specific ASTM value)	120 +/- 3 mm
Thickness (mm) (Single Layer)
Finger	Min 0.05	0.08 minimum
Palm	Min 0.05	0.08 minimum
Physical Properties - Before Aging
Tensile Strength (Mpa)	Min 14.0	20.4*
Ultimate Elongation (%)	Min 500	618*
Physical Properties - After Aging
Tensile Strength (Mpa)	Min 14.0	21.3*
Ultimate Elongation (%)	Min 400	616*
Powder Content	- (not specified in ASTM D6319-00aE3)	Below 2mg / glove (meets FDA Requirements)
Biocompatibility Test	- (not specified in ASTM D6319-00aE3)	Pass (Primary Dermal Irritation Test, Guinea Pig Sensitization (Buehler) test)

Note: The asterisk () indicates average results from Attachment C, which is not provided in the given document.*

Study Details:

This document is a 510(k) summary for medical gloves, which are considered Class I devices. The studies performed are primarily bench tests and material characterization, aligning with the regulatory requirements for such devices. The concept of "AI" or "algorithms" does not apply to this type of device.

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

The document implies that testing was conducted on samples of the manufactured gloves to ensure they meet the specified standards. However, the specific sample sizes for each test (e.g., number of gloves for watertight test, length, width, thickness, tensile strength, elongation, powder content, and biocompatibility) are not explicitly stated in the provided text.
The data provenance is from Seal Polymer Industries Berhad, Malaysia, presumably from their internal testing facilities. The tests are described as performance data of gloves, which indicates a prospective testing approach on manufactured products.

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

This is not applicable as the device is a physical medical glove. The "ground truth" is established by adherence to recognized industrial standards (ASTM D6319-00aE3) and FDA requirements, rather than expert interpretation of complex data like medical images. The tests involve objective measurements and established protocols.

4. Adjudication method for the test set:

This is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic or imaging studies. For physical product testing, results are determined by direct measurement against quantitative 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:

This is not applicable. This is a physical medical device (examination gloves), not an AI/software device involving human readers or interpretation of cases.

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

This is not applicable. This is a physical medical device; there is no algorithm involved.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on established industrial standards (ASTM D6319-00aE3) and specific FDA requirements (e.g., watertight test, powder residual content, pinhole requirements, biocompatibility standards). These standards define the acceptable performance characteristics for patient examination gloves.

8. The sample size for the training set:

This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI. The manufacturing process of the gloves would involve quality control and process validation, but not a "training set" in the computational sense.

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

This is not applicable as there is no training set for this physical device.

Summary

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K042238/si

SEP 1 6 2004

SEAL POLYMER INDUSTRIES BERHAD

Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

1.0		SMDA 510 (K) SUMMARY
2.0	Submitter	SEAL POLYMER INDUSTRIES BERHADLot 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 13, 2004
3.0	Name of Device
	Product Name	Cashmere Polymer Coated Powder Free NitrileExamination Gloves (Blue, White, Violet, Pink,Green)
	Common Name	Exam Glove
	Classification Name	Nitrile Patient Examination Glove

Identification of the Legally Marketed Devices 4.0

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.

5.0 Description of The Device

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 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 Q

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SEAL POLYMER INDUSTRIES BERHAD

Lot 72706, Jalan 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 D6319-00a53 and FDA 1000 ml watertight test.

TEST	ASTM D6319-00aE3AQL=2.5%	POLYMER COATED POWDER FREE NITRILE EXAM GLOVESAQL=2.5%
1. Watertight (1000 ml)	G I	Pass GI
2. Length (mm)Size	Min 230	240 mm minimum for all sizes
XS	Min 230
S	Min 230
M	Min 230
L	Min 230
XL	Min 230
3. Palm width (mm)Size	-	<80 mm
XS	80 +/- 10	85 +/- 3 mm
S	95 +/- 10	95 +/- 3 mm
M	111 +/- 10	105 +/- 3 mm
L	-	111 +/- 3 mm
XL	-	120 +/- 3 mm
XXL
4. Thickness (mm)(Single Layer)
Finger	Min 0.05	0.08 minimum
Palm	Min 0.05	0.08 minimum
5. Physical PropertiesBefore AgingTensile Strength (Mpa)	Min 14.0	20.4*
Ultimate Elongation (%)	Min 500	618*
After AgingTensile Strength (Mpa)	Min 14.0	21.3*
Ultimate Elongation (%)	Min 400	616*
6. Powder Content	-	Below 2mg / glove

indicates the average results from Attachment C. .

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SEAL POLYMER INDUSTRIES BERHAD

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 D6319-00a" 8. Standard and FDA's requirement. Standard and I Dr. For ow 2mg per glove, which meet the FDA Requirements.
The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
Conclusion 10.

We concluded that the Polymer Coated Powder Free Nitrile Examination Gloves meet the below specifications:

ASTM D6319-00a53 Standard -
FDA pinhole requirements ・
FDA minimum powder residual content -

Page 3 of 3 ATTACHMENT Q

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

SEP 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Chun Chooi Fong Quality Management System Manager Seal Polymer Industries Berhad Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak, MALAYSIA

Re: K042238

Trade/Device Name: Cashmere Polymer Coated Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Green) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 9, 2004 Received: September 13, 2004

Dear Ms. 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Mr), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device our re roublish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. 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 and if in the (s 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) rms receet 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), n you dontact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Chiu Lin, Ph. D.

Chiu Lin, Ph., D. 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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K042238/s1

INDICATIONS FOR USE STATEMENT

: Seal Polymer Industries Berhad Applicant

510(K) Number :

: Cashmere Polymer Coated Powder Free Nitrile Examination Gloves (Blue, Device Name White, Violet, Pink, Green)

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Morley

sthasi

510(k)

Page 1 of

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.