The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined. It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

Device Description

It is the powder-free variation of the class II latex patient examination gloves made by washing the gloves in a chlorine solution followed by an effective chemical removal and acid neutralization steps. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive or allergic to the powdered version of the same gloves.

AI/ML Overview

The device in question is a pair of Rubbercare Powder-Free/Guardian Powder-Free Latex Examination Gloves with a Protein Labeling Claim (50 micrograms or less).

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

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (ASTM Specifications)	Reported Device Performance (Measured Values)
Length, 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 ± 10	94 - 98
Tensile Strength, Before Aging, Mpa	21 min.	24 - 32
Tensile Strength, After Aging, Mpa	16 min.	20 – 28
Ultimate Elongation, Before Aging, %	700 min.	800 - 900
Ultimate Elongation, After Aging, %	500 min.	700 - 800
Water Extractable Protein, µg per gm	n.a. (implicit "50 and below" by claim)	50 and below
Water Leak Test, Before Aging, AQL	2.5	1.5 and below
Water Leak Test, After Aging, AQL	4.0	2.5 and below
Residual Powder (size M), mg	2 mg/glove	1 mg/glove
Skin Irritation Test	n.a. (implicit "Passed" by claim)	Passed *
Dermal Sensitization Test	n.a. (implicit "Passed" by claim)	Passed *

Note: "n.a." for Protein, Skin Irritation, and Dermal Sensitization implies that these were specific claims or tests conducted without a direct numerical ASTM specification provided in the table, but the results were explicitly stated to "Pass" or meet a defined threshold (like "50 and below" for protein). The document explicitly states these "meet all the requirements of ASTM standard D 3578-99" and other FDA requirements.

The study conducted to prove the device meets these criteria is an internal product testing and evaluation process by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD. The results, as presented in the table, demonstrate the glove's compliance with the ASTM standard D 3578-99, FDA pinhole requirements, and the protein content labeling claim.

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

Sample Size: The document does not explicitly state the specific sample sizes for each test (e.g., how many gloves were tested for length, thickness, tensile strength, etc.). It provides ranges of "Measured Values" which suggests that multiple samples were tested for each parameter.
Data Provenance: The testing was conducted by PERUSAHAAN PELINDUNG GETAH (M) SDN BHD, a Malaysian company. Therefore, the data originates from Malaysia. The study is retrospective in the sense that the data presented reflects tests already performed on the manufactured gloves.

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

This type of device (patient examination gloves) does not typically involve "experts" establishing a subjective ground truth in the way medical imaging or diagnostic devices might.
The "ground truth" for these tests is based on objective, standardized measurements performed according to ASTM standards and FDA requirements. The measurements are taken by laboratory personnel or quality control technicians. The document does not specify the number or qualifications of the individuals who performed these measurements, but it is implied they are qualified to conduct such tests according to established protocols.

4. Adjudication Method for the Test Set:

Adjudication methods like "2+1" or "3+1" are not applicable here. This refers to consensus building among multiple human reviewers for subjective assessments.
For objective laboratory tests of physical properties and chemical content, the results are quantitative measurements. The "adjudication" is inherent in the measurement protocol itself, with results being compared directly against the specified ASTM and FDA thresholds. If a measurement falls within the acceptable range, it passes; otherwise, it fails.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of medical imaging or diagnostic AI on human reader performance, which is not relevant for physical medical devices like examination gloves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone "algorithm only" study was not done. This device is a physical product, not an AI algorithm. The performance is assessed directly through physical and chemical testing, not through an algorithm's output.

7. Type of Ground Truth Used:

The ground truth used for this study is based on objective, measurable criteria defined by:
- ASTM standard D 3578-99 for Latex Examination Gloves.
- FDA pinhole requirements.
- Company's own labeling claim for protein content (50 micrograms or less).
- FDA biocompatibility requirements (implied by "Passed*" for Skin Irritation and Dermal Sensitization tests, which likely refer to ISO 10993 or similar standards).

8. Sample Size for the Training Set:

This concept is not applicable here. "Training set" refers to data used to train a machine learning algorithm. This device is a manufactured physical product, not an AI or software device that undergoes a training process.

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

This question is not applicable as there is no training set for a physical examination glove.

Summary

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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

510(K) SUMMARY

K994201

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	18th November 1999

Device Information

Trade Name	RUBBERCARE POWDER-FREELATEX EXAMINATION GLOVES WITH PROTEINLABELING CLAIM [50 MICROGRAMS OR LESS ]GUARDIAN POWDER-FREELATEX EXAMINATION GLOVES WITH PROTEINLABELING CLAIM [50 MICROGRAMS OR LESS ]
Common Name	Powder-free Latex Exam Gloves
Classification Name	Patient Examination Gloves

Claim of Equivalence

The device is a class II latex patient examination gloves 80LYY which is made powder-free by a process of chlorination and meets all the requirements of ASTM standard D 3578-99.

Device Description

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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

Intended Use of Device

The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined.

It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

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, powder-free and any other requirements, and any other parameter on which we want to make a labeling claim.

Parameter	ASTM Specifications	Measured Values
Length, 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 ± 10	94 - 98
Tensile Strength, Before Aging, Mpa	21 min.	24 - 32
Tensile Strength, After Aging, Mpa	16 min.	20 – 28
Ultimate Elongation, Before Aging, %	700 min.	800 - 900
Ultimate Elongation, After Aging, %	500 min.	700 - 800
Water Extractable Protein, µg per gm	n.a.	50 and below
Water Leak Test, Before Aging, AQL	2.5	1.5 and below
Water Leak Test, After Aging, AQL	4.0	2.5 and below
Residual Powder (size M), mg	2 mg/glove	1 mg/glove
Skin Irritation Test	n.a	Passed*
Dermal Sensitization Test	n.a	Passed*

Please refers attachment L

Conclusions

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

a. meet or exceed the ASTM standard D 3578-99
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 is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures, possibly representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

Mr. Peter Yew Nieng Choon Managing Director of Perusahaan Pelindung Getah (M) Sdn. Bhd. Lot 110, Lorong Senawang 4/3 Off Jalan Senawang Empat Senawang Industrial Estate 70450 Seremban Neqeri Sembilan Darul Khusus, Malaysia

Re : K994201

Rubbercare Powder-Free, Guardian Powder-Free Trade Name: Latex Exam Gloves With Protein Labeling Claim (50 Micrograms or Less) Requlatory Class: I Product Code: LYY November 19, 1999 Dated: December 13, 1999 Received:

Dear Mr. Choon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP

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Page 2 - Mr. Choon

requlation may result in regulatory action. In addition, FDA regulation may rebure in regulated oncerning your device in may publicit railer announce othis response to your ene release notification submission does not affect any premarker notification basmiser sections 531 through 542 of obligation you magne mare the Electronic Product Radiation the Act for devices andorher Federal laws or regulations.

This letter will allow you to begin marketing your device as first receir warr 510 k) premarket notification. The FDA described in your sio\n, promatence of your device to a legally finding of substancial equiralits in a classification for your marketed predicate as the your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulacion (ir c devices), please contact the Office of Compliance at (301) 594-4692. 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
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from the Drvibion (800) 638-2941 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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INDICATION FOR USE

Applicant:	PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
510(k) No.	K 994201

Powder-free Latex Examination Gloves with PlotEln LABELING Device Name:

Indications for Use

The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined.

It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

Chiu S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 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.