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 patients' body, fluids, -.

Device Description

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

AI/ML Overview

The provided document describes the acceptance criteria and study for "Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White)".

Description of the Device and Intended Use:
The device is a Class 1 Nitrile Patient Examination Glove, powder-free, intended to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.

Acceptance Criteria and Reported Device Performance:

TEST	ASTM D6319-00 / FDA Requirement	CASHMERE POWDER FREE NITRILE EXAM GLOVES (Reported Performance)	Meets Criteria?
1. Watertight (1000 ml)	GI AQL=2.5%	Pass GI AQL=2.5%	Yes
2. Length (mm) - All sizes	Min 230	240 mm minimum for all sizes	Yes
3. Palm width (mm)
XS	-	<80	Not directly comparable, but implied acceptable.
S	80 +/- 10	82 - 88	Yes
M	95 +/- 10	92 - 98	Yes
L	111 +/- 10	102 - 108	Yes
XL	-	>110	Not directly comparable, but implied acceptable.
4. Thickness (mm) (Single Layer)
Finger	Min 0.08	0.10 minimum	Yes
Palm	Min 0.08	0.10 minimum	Yes
5. Physical Properties - Before Aging
Tensile Strength (Mpa)	Min 14.0	15.2	Yes
Ultimate Elongation (%)	Min 500	670	Yes
6. Physical Properties - After Aging
Tensile Strength (Mpa)	Min 14.0	19.7	Yes
Ultimate Elongation (%)	Min 400	760	Yes
7. Powder Content	Below 2mg / glove (FDA requirement)	Below 2mg / glove	Yes
8. Biocompatibility Test	Pass (implied requirement for medical devices)	Pass (Primary Dermal Irritation, Guinea Pig Sensitization)	Yes

Study Information:

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each test mentioned in the table. It refers to "GI AQL=2.5%" for the watertight test, which indicates a sampling plan based on Acceptance Quality Limit, but not the specific number of gloves tested.
- Data Provenance: The studies were conducted by SEAL POLYMER INDUSTRIES SDN. BHD. in Malaysia. The nature of the tests (physical property measurements, watertight tests, biocompatibility) implies prospective testing on manufactured gloves.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the studies are technical performance tests against established standards (ASTM D6319-00, FDA requirements) and not diagnostic or interpretive tasks requiring expert ground truth establishment.
Adjudication method for the test set:
- Not applicable for these types of performance tests. The results are objective measurements against defined minimums or ranges.
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:
- No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is not relevant for the performance evaluation of examination gloves, which are physical medical devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical glove, not an algorithm.
The type of ground truth used:
- The "ground truth" for the performance tests consists of established industry standards and regulatory requirements:
  - ASTM D6319-00 Standard for Nitrile Patient Examination Gloves.
  - FDA 1000 ml watertight test requirements.
  - FDA minimum powder residual content requirements.
- For the biocompatibility tests, the ground truth is "Pass" based on established biological safety evaluation methods (Primary Dermal Irritation Test and Guinea Pig Sensitization test).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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APR 2 2 2002

K 020868

SEAL POLYMER INDUSTRIES SDN. BHD. 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 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	14th January 2002
3.0	Name of Device
	Trade Name	Cashmere Non-Sterile, Powder Free NitrileExamination Gloves (White)
	Common Name	Exam Glove
	Classification Name	Nitrile Patient Examination Glove

4.0 Identification of the Legally Marketed Devices

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

6.0 The Intended Use of Glove

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 L

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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

7. Summary of Performance Data:

Performance data of gloves based on ASTM D6319-00 and FDA 1000 ml watertight test.

TEST	ASTM D6319-00	CASHMERE POWDERFREE NITRILE EXAMGLOVES
1. Watertight (1000 ml)	GIAQL=2.5%	Pass GIAQL=2.5%
2. Length (mm)
SizeXS	Min 230	240 mm minimum forall sizes
S	Min 230
M	Min 230
L	Min 230
XL	Min 230
3. Palm width (mm)
SizeXS	-	<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 Properties
Before Aging
Tensile Strength (Mpa)	Min 14.0	15.2
Ultimate Elongation (%)	Min 500	670
After Aging
Tensile Strength (Mpa)	Min 14.0	19.7
Ultimate Elongation (%)	Min 400	760
6. Powder Content	-	Below 2mg / glove

Page 2 of 3 ATTACHMENT L

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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

1. The performance data of the glove as showed above meet the ASTM D6319-00 Standard and FDA's requirement. Powder content is below 2mg per glove, which meet 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.

10. Conclusion

We concluded that the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves meet:

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

Page 3 of 3 ATTACHMENT L

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2002

Mr. Chun Chooi Fong Quality Assurance Department Manager Seal Polymer Industries Sdn. Bhd. LT 72706. Jalan Lahat, Kawasan Perindustrian Bukit Merah Lahat, Ipoh, Perak, MALAYSIA 31500

Re: K020868

Trade/Device Name: Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: March 13, 2002 Received: March 18, 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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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,

Timothý Ulatowski 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

: Seal Polymer Industries Sdn. Bhd. Applicant

Ko20868 510(K) Number :

Device Name : Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White)

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 patients' body, fluids, -.

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

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

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

Qian S. Lin

(Division Sign-Off) (Division of Dental, Infection Control, Division ral Hospital Devices 510(k) Number --

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.