A Powder Free Patient examination gloves 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

White 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, white colour, powder free and non sterile.

This White Nitrile Medical Examination Gloves Powder Free 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

AI/ML Overview

This document describes the regulatory submission for EMG White Nitrile Medical Examination Gloves Powder Free and does not pertain to an AI/ML device. Therefore, the questions related to AI/ML specific criteria (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable.

The acceptance criteria and device performance are based on established standards for medical examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria	Reported Device Performance (EMG White Nitrile Medical Examination Gloves Powder Free, K141510)
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 the stated intended use
Material use	Not made from Natural Rubber Latex	Nitrile latex compound
Colour	White	White
Sterility	Non sterile	Non sterile
Dimensions (ASTM D6319-10)		Meets ASTM D6319-10
	Overall Length (mm): Min 230mm	230min (for all sizes S, M, L, XL)
	Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm	Size S = 85, Size M = 95, Size L = 105, Size XL = 115
	Thickness at Palm (mm): Min 0.05min	0.05min (for all sizes S, M, L, XL)
	Thickness at Finger Tip (mm): Min 0.05min	0.05min (for all sizes S, M, L, XL)
Physical properties (ASTM D6319-10)		Meets ASTM D6319-10
	Before Ageing
	Tensile Strength (MPa): Min 14min	14min
	Ultimate Elongation (%): Min 500min	500min
	After Aging at 70°C for 168 hrs @ 100°C for 22 hrs
	Tensile Strength (MPa): Min 14min	14min
	Ultimate Elongation (%): Min 400min	400min
Freedom from pinholes	AQL 2.5, Inspection Level G-1	Meets ASTM D5151-06 (which specifies AQL 2.5 for general purpose examination gloves)
Residual Powder	≤ 2.0 mg/pc	Meets ASTM D6124-06 (specifies residual powder amount)
Biological Evaluation on Medical Device - Primary Skin Irritation Test	Test Article was non irritant	Under the conditions of this study, the test article was a non-irritant
Biological Evaluation on Medical Device - Dermal Sensitization Assay	Test Article was non sensitizer	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:
This information is not explicitly detailed in the provided document. The compliance is stated against ASTM standards (e.g., ASTM D6319-10 for physical properties and dimensions, ASTM D5151-06 for pinholes, ASTM D6124-06 for residual powder) which dictate the sampling plans and testing methodologies. The studies for biological evaluation (Primary Skin Irritation Test and Dermal Sensitization Assay) would also follow specific protocols to determine "non-irritant" and "non-sensitizer" classifications, likely involving in-vivo (animal) or in-vitro tests, but the sample size and data provenance are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. Ground truth for device performance (e.g., tensile strength, pinholes) is established through physical and chemical testing following standardized protocols (ASTM standards), not through expert consensus in the medical imaging sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is not a diagnostic device requiring human interpretation of results.

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 not an AI/ML diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is derived from objective measurements based on widely accepted international standards for medical examination gloves (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06) and biological evaluation tests.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

Summary

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

October 7,2014

Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23836, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Kamunting Perak, Malaysia 34600

Re: K141510

Trade/Device Name: EMG White Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 5, 2014 Received: September 5, 2014

Dear Mr. 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. 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

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

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/Resourcesfor You/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,

Susan Runnan DDS, mA

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) K141510

Device Name

EMG White Nitrile Medical Examination Gloves Powder Free

Indications for Use (Describe)

A Powder Free Patient examination gloves 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)

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FOR FDA USE ONLY

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

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formerly known as Sinetimed Consumables Sdn. Bhd.

t 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA, TEL +60-5-891 2777 FAX +60-5-891 2999

Appendix 2 510K#: K141510

510(K) Summary EMG White Nitrile Medical Examination Glove Powder Free .

1.0 Submitter :

Company Name	: ECO MEDI GLOVE SDN. BHD
Company Address	: Lot 23826,Jalan Tembaga KuningKamunting Raya Industrial Estate,34600,Kamunting PerakMalaysia.
Contact Person	: Mr Suresh Kumar
Telephone No	: 603-60283033
Email	: suresh@ecomediglove.com.my

2.0 Preparation Date : 22th September 2014

3.0 Name of the Device

Trade Name / Proprietary Name : EMG White Nitrile Medical Examination Gloves Powder Free

Device Name : Nitrile Patient Examination gloves

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

Device Class : Class I

Product Code : Nitrile-LZA

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(formerly known as Sinetimed Consumables Sdn. Bhd.)

Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA.

Appendix 2 510K#: K141510

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 K112928, RS White Nitrile Medical Examination Gloves Powder Free ( Non-Sterile )

5.0 Description of Device

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(formerly known as Sinetimed Consumables Sdn. Bhd.)

26, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. 60-5-891 2777

Appendix 2 510K#: K141510

6.1. Specification for Nitrile gloves: 6.1.1 Dimension and Thickness of Gloves

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

6.3.2.2 Gloves Physical Properties and Holes

Measurement	Before Ageing	After Aging at 70°C for168 hrs @ 100°C for 22 hrs
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 meet all the specification listed in ASTM D 6319-10

7.0 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.

8.0 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 .

Gloves are made from nitrile latex compound, White colour, powder free and non

sterile. It is equivalent to K112928, RS White Nitrile Medical Examination Gloves

Powder Free ( Non-Sterile )

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(formerly known as Sinetimed Consumables Sdn. Bhd.)

Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999

Appendix 2 510K#: K141510

Characteristics	Acceptance Criteria	EMG White NitrileMedical ExaminationGlovesPowder Free,K141150	RS White NitrileMedical ExaminationGloves Powder Free(Non-Sterile ) K112928
Product Code	LZA	LZA	LZA
Intended use	A powder free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner. The device isfor over-the-counteruse. 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 device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use.
Material use	Not made from Natural RubberLatex	Nitrile latex compound	Nitrile latex compound
Colour	White	White	White
Sterility	Non sterile	Non sterile	Non sterile
Dimensions	Overall Length (mm)= Min 230mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)= Min 0.05minThickness at Finger Tip (mm)= Min 0.05min	Meets ASTM D6319-10	Meets ASTM D6319-10

Physical properties	Before AgeingTensile Strength (MPa)= Min 14minUltimate Elongation (%)= Min 500minAfter Aging at 70°C for168 hrs @ 100°C for 22 hrsTensile Strength (MPa)= Min 14minUltimate Elongation (%)= Min 400min	Meets ASTM D6319-10	Meets ASTM D6319-10
Freedom from pinholes	AQL 2.5Inspection Level G-1	Meets ASTM D5151-06	Meets ASTM D5151-06
Residual Powder	≤ 2.0 mg/pc	Meets ASTM D6124-06	Meets ASTM D6124-06
Biological Evaluation onMedical Device -Primary Skin IrritationTest	Test Article was non irritant	Under the conditions ofthis study, the test articlewas a non-irritant	Under the conditions ofthis study, the test articlewas a non-irritant
Biological Evaluation onMedical Device-Dermal SensitizationAssay	Test Article was non sensitizer	Under the conditions ofthis study, the test articlewas a non-sensitizer.	Under the conditions ofthis study, the test articlewas a non-sensitizer.

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(formerly known as Sinetimed Consumables Sdn. Bhd.)

Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999

Appendix 2 510K#: K141510

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(formerly known as Sinetimed Consumables Sdn. Bhd.)

Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999

Appendix 2 510K#: K141510

9.0 Conclusion

It can be concluded that EMG White Nitrile Medical Examination Gloves Powder Free

and predicate devices are substantially equivalent base on intended uses, physical

properties, technological characteristics and non-clinical performance

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.