The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

Device Description

The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove (Aqua Green). The subject device is a patient examination glove made from nitrile compound, Aqua Green color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove (Aqua Green):

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria	Reported Device Performance (Powder Free Nitrile Examination Glove (Aqua Green), K200326)
Product Code	LZA	LZA
Intended Use	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. The device is for over-the-counter use.	Meets intended use description.
Material Use	Nitrile compound	Nitrile compound
Color	N/A (not a criterion for equivalence, but noted as different from predicate)	Aqua Green
Sterility	N/A	Non sterile
Single Use	Single used	Single used
Dimensions	Overall Length: Min 230mm; Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm; Thickness at Palm: Min 0.05 mm; Thickness at Finger Tip: Min 0.05 mm (Per ASTM D6319-10)	Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these)
Physical Properties (Before Aging)	Tensile Strength: 14min MPa; Ultimate Elongation: 500min % (Per ASTM D6319-10)	Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these)
Physical Properties (After Aging)	Tensile Strength: 14min MPa; Ultimate Elongation: 400min % (after 70ºC for 168 hrs @ 100ºC for 22 hrs) (Per ASTM D6319-10)	Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these)
Freedom from Pinholes	AQL 2.5, Inspection Level G-1 (Per ASTM D5151-06)	Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1)
Residual Powder	< 2.0 mg/pc (Per ASTM D6124-06)	Meets ASTM D6124-06 (Reported values: 0.49, 0.38, 0.43, 0.51, 0.22 mg/glove)
Biocompatibility (Primary Skin Irritation)	ISO 10993-10 - Primary Skin Irritation Test (Expected: non-irritant)	Under the conditions of this study, the test article was a non-irritant.
Biocompatibility (Dermal Sensitization)	ISO 10993-10 - Dermal Sensitization Assay (Expected: non-sensitizer)	Under the conditions of this study, the test article was a non-sensitizer.
Biocompatibility (Acute Systemic Toxicity)	ISO 10993-11 - Acute Systemic Test (Expected: Not induce systemic toxicity)	Not induce systemic toxicity

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

The document provides details about the testing performed according to various ASTM and ISO standards for properties like dimensions, physical properties, pinholes, residual powder, and biocompatibility. However, it does not explicitly state the specific sample sizes used for each of these tests. The standards themselves would dictate the sample sizes (e.g., ISO 28590:2017 is cited for "Sampling Procedure for Inspection by Attributes").

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted for the purpose of this 510(k) submission, performed by the manufacturer or a contracted lab. The submitter's address is Malaysia, suggesting the testing likely occurred there or at a laboratory serving that region.

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

This information is not applicable to this type of device and study. The "ground truth" for medical examination gloves is established through objective physical and chemical testing against defined industrial standards (ASTM, ISO). It does not involve expert interpretation or consensus in the same way an imaging or diagnostic AI device would.

4. Adjudication Method for the Test Set

This is not applicable. As in point 3, the assessment is based on objective measurements against established standards, not on subjective interpretations requiring 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

This is not applicable. The device is a medical examination glove, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical product (glove) and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and objective measurements. Specifically:

Physical and Mechanical Properties: Defined by ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves), ASTM D412-16 (Tensile strength and elongation).
Freedom from Pinholes: Defined by ASTM D5151-06.
Residual Powder: Defined by ASTM D6124-06.
Biocompatibility: Defined by ISO 10993-10 (Irritation and Sensitization), ISO 10993-11 (Systemic Toxicity), and 16 CFR:1500.41 (Primary Irritant Substance).
Sampling: Guided by ISO 28590:2017.

These standards provide the quantitative and qualitative acceptance criteria against which the device's performance is measured.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

This is not applicable. As explained in point 8, there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of that is the FDA logo, which is the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2020

Riverstone Resources SDN BHD Suresh Kumar Official Correspondent Lot 55. No 13 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 My

Re: K200326

Trade/Device Name: Powder Free Nitrile Examination Glove (Aqua Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 2, 2020 Received: February 10, 2020

Dear Suresh 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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 does 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows a light blue FDA logo. The letters are large and bold. The background is white.

Elizabeth F. Claverie -S

CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Section 1A-1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200326

R200326

Device Name

Powder Free Nitrile Examination Glove (Aqua Green)

Indications for Use (Describe)

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)

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510(K) Summary

K200326

Powder Free Nitrile Examination Glove (Aqua Green)

Preparation Date: April 8th, 2020

1. Submitter:

Company Name: Riverstone Resource Sdn Bhd. Company Address: Lot 55,No 13, Jalan Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung 48300. Selangor Malaysia.

Contact Person: Mr Suresh Kumar Telephone No: 603-60283033 Email: qa1@riverstone.com.my

2. Name of the Device

Trade Name / Proprietary Name: Powder Free Nitrile Examination Glove (Aqua Green) Device Name: Nitrile Patient Examination gloves. Device Classification Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA

3. Identification of The Legally Marketed Device:

Predicate Device: K141579 Device Name: Emg Black Nitrile Medical Examination Glove Powder Free Device Classification Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA

4. Device Description

5. Intended use of the Device

Powder Free Nitrile Examination Glove (Aqua Green) 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.

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Characteristics	Acceptance Criteria	Subject device,Powder FreeExamination Glove(Aqua green),K200326	Predicate device,EMG Blue NitrileMedical ExaminationGlove, K141579	Remarks
Product Code	LZA.	LZA.	LZA.	same
Intended use	A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger 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 wornon the examiner's handor finger 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 wornon the examiner'shand or finger toprevent contaminationbetween patient andexaminer. The deviceis for over-the-counteruse.	same
Material use	Nitrile compound	Nitrile compound	Nitrile compound	same
Colour	N/A	Aqua Green	Blue	Different
Sterility	N/A	Non sterile	Non sterile	same
Single used	Single used	Single used	Single used	same
Dimensions	Overall Length (mm)Min 230mm Width (±5mm) Size S = 85mmSize M = 95mm Size L= 105mm SizeXL = 115mmThickness at Palm(mm)Min; 0.05 mmThickness at Finger Tip(mm) Min 0.05 mm	Meets ASTM D6319-10	Meets ASTM D6319-10	same
Physicalproperties	Before Ageing TensileStrength (MPa)= 14min UltimateElongation (%)= 500min After Agingat 70oC for168 hrs @ 100oC for22 hrs Tensile Strength(MPa)= 14min UltimateElongation (%)	Meets ASTM D6319-10	Meets ASTM D6319-10	same
Freedom frompinholes	AQL 2.5Inspection Level G-1	Meets ASTM D5151-06	Meets ASTM D5151-06	same
Residual Powder	< 2.0 mg/pc	Meets ASTM D6124-06	Meets ASTM D6124-06	same
Biocompatibility	ISO 10993-10-Biological Evaluationon Medical Device --Primary Skin IrritationTest	Under the conditions ofthis study, the testarticle was a non-irritant.	Under the conditionsof this study, the testarticle was a non-irritant.	same
	ISO 10993-10-Biological Evaluationon Medical Device -Dermal SensitizationAssay	Under the conditions ofthis study, the testarticle was a non-sensitizer.	Under the conditionsof this study, the testarticle was a non-sensitizer.	same
	ISO 10993-11-Acute Systemic test	Not induce systemictoxicity	N/A	Same

6. Technological characteristics Comparison for the proposed and predicate devices

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7. Summary of non-clinical testing results

Powder Free Nitrile Examination Glove (Aqua Green) was tested and found in conformance with the following standards:

ASTM D6319-10	Standard Specification for Nitrile Examination Gloves for MedicalApplication
ASTM D412-16	Standards test method for Vulcanized Rubber and ThermoplasticsElastomer - Tension
ASTM D5151-06	Standard Test Method for detection of Holes in Medical Gloves
ASTM D6124-06	Standard Test Method for Residual Powder on Medical Gloves
16 CFR:1500.41	Method of Testing Primary Irritant Substance
ISO 10993-10	Biological evaluation on medical device Part 10: Test for irritation andSkin Irritation
ISO 10993-11	Biological evaluation of medical devices Part 11: Tests for systemictoxicity
ISO 28590:2017	Sampling Procedure for Inspection by Attributes: Introduction to theISO 2859 series of standards for sampling for inspection by attributes.

Dimension and Thickness of Gloves (ASTM D6319-10)
Dimension	Size S	Size M	Size L	Size XL
Overall Length (mm)	230min	230min	230min	230min
Width (± 5mm)	85	95	105	115
Thickness at Palm (mm)	0.05min	0.05min	0.05min	0.05min
Thickness at Finger Tip (mm)	0.05min	0.05min	0.05min	0.05min

(ASTM D6310 10) d Thick f City

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Measurement	Before Ageing	After Aging at 70ºC for168 hrs @ 100ºC for 22hrs
Tensile Strength (MPa)	14min	14 Min
Ultimate Elongation (%)	500min	400min
Pin-hole Level	AQL 2.5Inspection Level G-1	AQL 2.5Inspection Level G-1

Gloves Physical Properties and Holes (ASTM D6319-10)

Residual Powder (ASTM D6124-06)

Sample No.	Residual Powder (mg/glove)
1	0.49
2	0.38
3	0.43
4	0.51
5	0.22
Requirements	<2.0

8. Conclusion

The Conclusion drawn from the Non-Clinical test demonstrates that the subject device, Powder Free Nitrile Examination Glove (Aqua Green) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K141579.

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.