A 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.

Device Description

Orange Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, orange colour, powder free and non sterile.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device: "RS Orange Nitrile Medical Examination Gloves (Powder Free)". This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a full-fledged clinical study in the way a new, high-risk device might.

Therefore, the requested information about clinical study design, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, and standalone algorithm performance does not directly apply to this type of submission. The "study" here refers to non-clinical performance testing and biocompatibility assessments against established standards.

Here's an interpretation of the document in the context of your request:

Acceptance Criteria and Device Performance

The device demonstrates performance against recognized standards, specifically ASTM D6319-10 for physical characteristics and FDA-recommended biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (Standards)	Device Performance (RS Orange Nitrile Medical Examination Gloves Powder Free)
Physical Properties
Dimension	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from pinholes	ASTM D 6319-10	Meets
Powder-Free	ASTM D 6319-10	Meets
Biocompatibility
Primary Skin Irritation Test	Consumer Product Safety Commission, Title 16, Chapter II, Part 1500	Under the conditions of this study, the test article was a non-irritant.
Dermal Sensitization Assay	ISO 10993-10:2010(E)	Under the conditions of this study, the test article was a non-sensitizer.

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

The document does not specify the exact sample sizes used for the physical and biocompatibility tests. These are typically standard tests performed on batches of gloves according to the relevant ASTM and ISO standards. The data provenance would be from laboratory testing of the manufactured gloves. The document originates from Malaysia (Riverstone Resources Sdn.Bhd.). The testing would be considered prospective in the sense that the tests were performed on the device being submitted.

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

This concept is not applicable here. The "ground truth" for glove performance is established by the specified standards (ASTM D 6319-10) and regulatory guidelines for biocompatibility. The results are objective measurements or categorical assessments (e.g., non-irritant, non-sensitizer) from laboratory testing, not subjective expert judgment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Laboratory tests have defined methods for determining outcomes, rather than requiring expert adjudication.

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 for a physical medical examination glove, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is for a physical medical examination glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is based on:

Standard Specifications: Meeting the chemical and physical property requirements defined by ASTM D 6319-10.
Biocompatibility Standards: Results from established laboratory tests (Primary Skin Irritation Test, Dermal Sensitization Assay) based on the Consumer Product Safety Commission guidelines and ISO 10993-10:2010(E).

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. This is a physical device, not a machine learning model.

Summary of the "Study" (Performance Testing):

The "study" for this device consists of non-clinical performance testing and biocompatibility assessments to demonstrate that the RS Orange Nitrile Medical Examination Gloves (Powder Free) meet the established requirements of ASTM D 6319-10 for physical properties (dimensions, physical properties, freedom from pinholes, powder-free status) and specific biocompatibility standards (Primary Skin Irritation Test and Dermal Sensitization Assay). The results consistently demonstrate that the device "Meets" the ASTM standard and was found to be a "non-irritant" and "non-sensitizer" in the biocompatibility tests. This data forms the basis for the conclusion that the device is substantially equivalent to the predicate devices and performs according to performance standards and FDA requirements.

Summary

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K133193

JUN 2 3 2014

Appendix 2 510(K) Summary Nitrile Examination Gloves Powder Free,Orange colour

1.0 Submitter :

Company Name	: Riverstone Resources Sdn.Bhd.
Company Address	: Lot 55&56,No.13&15 Jalaln Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit BeruntungSelangor,Malaysia.
Contact Person	: Mr Suresh Kumar

Telephone No : 603-60283033

Email : qal @riverstone.com.my

2.0 Preparation Date : 7th May 2014

3.0 Name of the Device

Trade Name / Proprietary Name : RS Orange Nitrile Mcdical Examination Gloves ( Powder Free)

Device Name : Nitrile Paticnt Examination gloves

Device Classification Name : Patient Examination gloves (21 CFR 880.6250)

Device Class : Class I

Product Code : Nitrile-LZA

4.0 Identification of The Legally Marketed Device :

Class I patient Examination gloves,Powder Free,LZA which meets all the

requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K

100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non-

Sterile ) and K112928, RS White Nitrile Examination glove Powder Free (Non

Sterile) except for colour.

Section 2A-1

. . . . .

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Appendix 2 5.0 Description of Device

6.0 Intended use of the Device

A powder-free 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. It is for over-the-counter use.

7.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion

There is no different technology characteristics compared to the predicate device expect colour. Gloves are made from nitrile latex compound, Orange colour, powder free and non sterile. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) and K112928 ,RS White Nitrile Medical Examination Glove Powder Free (Non Sterile) except for colour.

Section 2A-2

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Appendix 2

Characteristics	RS Orange NitrileMedical ExaminationGloves( Powder Free)K133193	RS Safe Blue NitrileMedical ExaminationGloves Powder Free( Non-Sterile ) K 100603	RS White NitrileMedical ExaminationGloves Powder Free( Non-Sterile ) K 112928
Product Code	LZA	LZA	LZA
Intended use	A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use.	A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use	A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use.
Material use	Nitrile latex compound	Nitrile latex compound	Nitrile latex compound
Colour	Orange	Blue	White
Sterility	Non sterile	Non sterile	Non sterile
Dimensions	Meets ASTM D6319-10	Meets ASTM D6319-10	Meets ASTM D6319-10
Physical properties	Meets ASTM D6319-10	Meets ASTM D6319-10	Meets ASTM D6319-10
Freedom from pinholes	Meets ASTM D6319-10	Meets ASTM D6319-10	Meets ASTM D6319-10
Powder -Free	Meets ASTM D6319-10	Meets ASTM D6319-10	Meets ASTM D6319-10
Biocompatability test-Primary Skin Irritation Test	Under the conditions ofthis study, the test articlewas a non-irritant.	Under the conditions ofthis study, the test articlewas a non-irritant.	Under the conditions ofthis study, the test articlewas a non-irritant.
Dermal SensitizationAssay	Under the conditions ofthis study, the test articlewas a non-sensitizer.	Under the conditions ofthis study, the test articlewas a non-sensitizer.	Under the conditions ofthis study, the test articlewas a non-sensitizer.

Section 2A-3

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Appendix 2

RS Orange Nitrile Medical Examination Gloves Powder Free posting the following technological characteristics

compared to ASTM or Equivalent standards:

Characteristics	Standards	Device PerformanceRS ORANGE OrangeNitrile MedicalExamination GlovesPowder Free( Non-Sterile )
Dimension	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from pinhole	ASTM D 6319-10	Meets
Powder -Free	ASTM D 6319-10	Meets
Biocompatability	Primary Skin Irritation TestConsumer Product SafetyCommission, Title 16,Chapter II, Part 1500	Under the conditions of thisstudy, the test article was anon-irritant
Biocompatability	Dermal SensitizationAssay-ISO 10993-10:2010(E)	Under the conditions of thisstudy, the test article was anon-sensitizer.

8.0 Conclusion

It can be concluded that Orange Nitrile Medical Examination Gloves (Powder Free) will perform according to the glove performance standards ASTM D 6319-10, biocompatibility requirement and FDA requirements and the labeling claims for the product. Performance testing data demonstrates , RS Orange Nitrile Medical Examination Glove (Powder Free) is substantially equivalent to the predicate devices (K100603 and K112928)

Section 2A-4

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2014

Riverstone Resources Sdn Bhd Mr. Suresh Kumar OA Manager Lot 55&56. No.13&15 Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung Selangor MALAYSIA 48300

Re: K133193

Trade/Device Name: RS Orange Nitrile Medical Examination Gloves (Powder Free) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA May 23, 2014 Dated: Received: May 27, 2014

Dear Mr. Kumar:

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 cnactment 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kumar

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

Tejashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133193

Device Name

RS Orange Nitrile Medical Examination Gloves (Powder Free)

Indications for Use (Describe)

A 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sreekanth Gutala

Digitally signed by Sreekanth Gutala -S

DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.06.20 12:39:56 -04'00'

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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.