The RubberCare powdered latex 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.

Device Description

It is made from natural rubber latex using USP cornstarch as donning powder. The manufacturing process includes pre and post leaching stages to remove residual chemicals and water-soluble proteins. The extent of protein removal is within the limit of the ASTM D3578-01a24 recommended limits for both powder and water-soluble protein.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	ASTM Specifications (Acceptance Criteria)	Reported Device Performance (Measured Values)
Length (sizes M, L)	230 mm min.	240 - 245 mm
Thickness (palm)	0.08 mm min.	0.14 - 0.16 mm
Thickness (finger)	0.08 mm min.	0.16 - 0.20 mm
Width (size M)	95 ± 10 mm	94 - 98 mm
Tensile Strength (Before Aging)	18 Mpa min.	20 - 29 Mpa
Tensile Strength (After Aging)	14 Mpa min.	20 - 26 Mpa
Ultimate Elongation (Before Aging)	650% min.	750 - 900%
Ultimate Elongation (After Aging)	500% min.	750 - 950%
Water Extractable Protein	200 µg/dm² (recommended)	100 µg/gram and below
Water Leak Test (Before Aging) (AQL)	2.5	1.5 and below
Water Leak Test (After Aging) (AQL)	n.a. (not specified by ASTM)	2.5 and below
Residual Powder	10 mg/dm²	9 - 10 mg/dm²
Skin Irritation Test	n.a. (not specified by ASTM)	Passed*
Dermal Sensitization Test	n.a. (not specified by ASTM)	Passed*

Note: The document states these passed tests refer to "attachment H (page 19)" which is not included in the provided text, so specific criteria for these tests are not available here.

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

The document does not explicitly state the sample sizes used for testing each parameter. However, the data represents testing performed by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD, located in Seremban, Negeri Sembilan, Malaysia. The data is retrospective in the sense that it was collected and then summarized for this 510(k) submission.

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

This type of study (material properties testing for medical gloves) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The acceptance criteria are established by the ASTM (American Society for Testing and Materials) standard D 3578-01a2, which represents a consensus of experts in the field of rubber products. The testing itself is performed by laboratory technicians following standardized procedures.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations, but rather laboratory testing against established specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This document describes the performance of a medical device (gloves) against established material and performance standards, not a diagnostic algorithm that would typically involve human readers.

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

Yes, this can be considered a "standalone" performance evaluation in the sense that the device's physical and chemical properties were tested in isolation against established standards, without human interaction influencing the measurement of these properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is the ASTM D3578-01a2 standard specifications. These are industry-accepted, scientifically validated performance metrics for patient examination gloves.

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." The measurements presented are from a batch of manufactured gloves.

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

Not applicable, as there is no training set for this type of device. The ground truth (ASTM standards) is established through a consensus process by the ASTM organization, involving experts in the field.

Summary

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K032201

PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

(Company No. 169997-P) Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Fax: 606-6772780 Tel: 606-6772781

Image /page/0/Picture/5 description: The image contains two logos. The logo on the left has the letters "BVQi" stacked on top of each other, with a horizontal line underneath. Below the line, the text "ISO 9001" is printed. The logo on the right has a crown above a check mark, with the text "UKAS QUALITY MANAGEMENT" printed below.

Amended: October 2, 2003 (Original page 8 of 20)

510(K) SUMMARY

Applicant:	PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
Address	Lot 110, Lorong Senawang 4/3, Off Jalan Senawang EmpatSenawang Industrial Estate, 70450 Seremban,Negeri Sembilan, Malaysia.
Phone No.	60-6-6772781	Fax No.	60-6-6772780
Contact Person	Peter Yew Nieng Choon
Date of Summary	October 2, 2003
Device Information
Trade Name	RUBBERCARE
Common Name	Powdered Latex Exam Gloves
Classification Name	Patient Examination Glove, powdered

Claim of Equivalence

The device is a class I latex patient examination gloves 80LYY powdered with absorbable dusting powder, that meets all the requirements of ASTM standard D 3578-01a2.

Device Description

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PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

(Company No. 169997-P) Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban. Negeri Sembilan Darul Khusus, Malaysia Tel: 606-6772781 Fax: 606-6772780

Image /page/1/Picture/2 description: The image contains two logos. The logo on the left has the letters "BVQi" stacked on top of each other, with the text "ISO 9001" underneath. The logo on the right has a crown above a check mark, with the text "UKAS QUALITY MANAGEMENT" underneath.

Amended: October 2, 2003 (Original page 9 of 20)

Intended Use of Device

The device is intended as a protective device to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Technological Characteristics

Following is a table showing the measured parameters of the gloves (e.g. lengths, thickness, widths, physical properties, protein contents, etc) as compared to ASTM. Also data that meets FDA biocompatibility, pinhole, and any other requirements, and any other parameter on which we want to make a labeling claim.

Parameter	ASTM Specifications	Measured Values
Length (sizes M, L), mm	230 min.	240 - 245
Thickness (palm), mm	0.08 min.	0.14-0.16
Thickness (finger), mm	0.08 min.	0.16-0.20
Width (size M), mm	$95 \pm 10$	94 - 98
Tensile Strength, Before Aging, Mpa	18 min.	20 - 29
Tensile Strength, After Aging, Mpa	14 min.	20 - 26
Ultimate Elongation, Before Aging, %	650 min.	750 - 900
Ultimate Elongation, After Aging, %	500 min.	750-950
Water Extractable Protein, µg/gram	200µg/dm²	100µg/gram and below
	(recommended)
Water Leak Test, Before Aging, AQL	2.5	1.5 and below
Water Leak Test, After Aging, AQL	n.a.	2.5 and below
Residual Powder, mg/dm²	10	9-10
Skin Irritation Test	n.a	Passed*
Dermal Sensitization Test	n.a	Passed*

Please refers to attachment H (page 19)

Conclusions

Based on the test data given above, we certify that our gloves:

meet or exceed the ASTM standard D3578-01a22 a.
b. meet the FDA pinhole requirements; and
c. meet our labeling claim on protein content.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Mr. Peter Yew Nieng Choon Managing Director Perusahaan Pelindung Getah (M) SDN BHD Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Darul Khusus, MALAYSIA

Re: K032201

Trade/Device Name: Rubbercare Powdered Latex Examination Gloves (containing 100 Micrograms or Less of Total Water Extractable Protein Per gram) Regulation Number: Patient Examination Glove Regulation Name: 880.6250 Regulatory Class: I Product Code: LYY Dated: October 2, 2003 Received: October 6, 2003

Dear Mr. Nieng Choon:

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. Nieng Choon

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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.

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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PERUSAHAAN PELINDUNG GETAH (M) SDN BHD

(Company No. 169997-P) Lot 110, Lorong Senawang 4/3, Off Jalan Senawang Empat, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Fax: 606-6772780 Tel: 606-6772781

Image /page/4/Picture/2 description: The image contains two logos. The logo on the left has the letters "BVQi" in a bold, sans-serif font, with a horizontal line above and below the letters. Below the logo, the text "ISO 9001" is printed. The logo on the right has a check mark above the text "UKAS QUALITY MANAGEMENT".

Amended: October 2, 2003 (Original page 3 of 20)

INDICATIONS FOR USE

PERUSAHAAN PELINDUNG GETAH (M) SDN BHD Applicant:

K032201 510(k) No.

RubberCare Powdered Latex Examination Gloves (containing 100 Device Name: micrograms or less of total water extractable protein per gram)

Indications for Use

The RubberCare powdered latex examination glove is a disposable device intended for medical The Raober on on the examiner's hand or finger to prevent 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)

Sat. Pat. fx. Chan-Len

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K032201

Prescription Use (Pcr 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.