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.

Device Description

Pink Nitrile Examination Glove. Powder Free. 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, Pink color, Powder free and non sterile.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device: "EMG Pink Nitrile Examination Glove Powder Free." The primary goal of the submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K141590, EMG Blue Nitrile Medical Examination Glove Powder Free).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Characteristic	Acceptance Criteria	Reported Device Performance (EMG Pink Nitrile Examination Glove Powder Free, K161320)	Predicate Device (EMG Blue Nitrile Medical Examination Gloves (Powder Free), K141590)
Product Code	LZA	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 stated intended use.	Meets stated intended use.
Material Use	Not made from Natural Rubber Latex.	Nitrile latex compound.	Nitrile latex compound.
Colour	(Not specified as a performance criterion, but a distinguishing feature)	Pink, color	Blue, color
Sterility	Non sterile	Non sterile	Non sterile
Dimensions (Overall Length, Width, Thickness at Palm, Thickness at Finger Tip)	Overall Length (mm) = Min 230mm; Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm; Thickness at Palm (mm) = Min 0.05min; Thickness at Finger Tip (mm) = Min 0.05min	Meets ASTM D6319-10	Meets ASTM D6319-10
Physical Properties (Before Ageing)	Tensile Strength (MPa) = Min 14min; Ultimate Elongation (%) = Min 500min	Meets ASTM D6319-10	Meets ASTM D6319-10
Physical Properties (After Aging)	After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = Min 14min; Ultimate Elongation (%) = Min 400min	Meets ASTM D6319-10	Meets ASTM D6319-10
Freedom from Pinholes	AQL 2.5, Inspection 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 (Primary Skin Irritation Test)	Test Article was non irritant.	Under the conditions of this study, the test article was a non-irritant.	Under the conditions of this study, the test article was a non-irritant.
Biological Evaluation (Dermal Sensitization Assay)	Test Article was non sensitizer.	Under the conditions of this study, the test article was a 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:

The document does not explicitly state the sample sizes for the tests conducted to demonstrate compliance with ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, or the biological evaluation tests (skin irritation and dermal sensitization). These standards specify sampling plans, but the specific number of units tested is not reported in this summary.
Data Provenance: The submitting company, ECO MEDI GLOVE SDN. BHD., is located in Malaysia. Therefore, the data likely originates from testing conducted there, or by third-party labs often contracted by manufacturers for such compliance testing. The document states a "Preparation Date" of 20th July 2016, indicating the tests were conducted prior to this date. The data is retrospective relative to the submission date.

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

This information is not provided in the document. The tests performed (e.g., physical properties, pinhole, residual powder, biological evaluation) are standardized laboratory tests. The "ground truth" for these tests is defined by the methodology of the ASTM standards and biological evaluation protocols themselves, rather than by expert consensus on interpretations of images or findings. While qualified laboratory personnel perform these tests, their specific "expert" qualifications (e.g., years of experience) or number are not detailed.

4. Adjudication method for the test set:

Not applicable as the tests are objective, standardized laboratory measurements and assessments according to specific ASTM standards (D6319-10, D5151-06, D6124-06) and biological evaluation protocols. These types of tests typically do not involve multiple expert readers and subsequent adjudication in the way medical imaging interpretation might.

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. This document pertains to the 510(k) clearance of a patient examination glove, which is a physical medical device. It does not involve AI software or human readers interpreting medical cases. No MRMC study was performed.

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

Not applicable. This is a physical medical device (glove), not an algorithm or AI software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

The "ground truth" is established by adherence to recognized international and national standards for examination gloves:
- ASTM D 6319-10: Standard Specification for Nitrile Examination Gloves for Quality Assurance, Dimensional, and Physical Property (Tensile Strength, Ultimate Elongation) testing.
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves for Pin-hole Level.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves for Residual Powder.
- Biological Evaluation on Medical Device - Primary Skin Irritation Test: Assesses skin irritation potential.
- Biological Evaluation on Medical Device - Dermal Sensitization Assay: Assesses the potential for allergic sensitization.
These standards and biological tests define the objective criteria and methodologies against which the device's performance is measured.

8. The sample size for the training set:

Not applicable. This product is a physical device, not an AI/ML algorithm that requires a training set. The data presented are for performance testing of the final product.

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

Not applicable, as there is no training set for this device.

Summary

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

September 1, 2016

Eco Medi Glove Sdn. Bhd. Suresh Kumar Quality Assurance Manager Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate Kamunting Perak, 34600 MY

Re: K161320

Trade/Device Name: EMG Pink Nitrile Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 20, 2016 Received: July 27, 2016

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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.

Michael J. Ryan - S

for Tina Kiang, Ph.D.

Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161320

Device Name

EMG Pink Nitrile Examination Glove Powder Free

Indications for Use (Describe)

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

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)

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FORM FDA 3881 (1/14)

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(formerly known as Sinetimed ( mables Sdn

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

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

1.0 Submitter :

Company Name	: ECO MEDI GLOVE SDN. BHD.
Company Address :	: Lot 23826,Jalan Tembaga KuningKamunting Raya Industrial Estate34600,Kamunting PerakMalaysia .
Contact Person :	Mr Suresh Kumar
Telephone No :	603-60283033
Email :	suresh@ecomediglove.com.my

2.0 Preparation Date : 20th July 2016 .

3.0 Name of the Device

Trade Name / Proprietary Name : EMG Pink Nitrile Examination Glove 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.)

ot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA, TEL +60-5-891 2777 FAX +60-5-891 2000

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 K141590,EMG Blue Nitrile Medical Examination Glove (Powder Free) except the color

5.0 Description of Device :

6.0 Executive summary :

EMG Pink Nitrile Examination Glove, Powder Free is a disposable glove made of nitrile latex compound Pink color powder free. This Pink Nitrile 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 .

6.1.1 Specification for Nitrile gloves: 6.1.1.1 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

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ECO Medi

(formerly known as Sinetimed Consumables Sdn. Bhd.)

amunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. 3826 lalan Tembaga

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

6.3.2.2 Gloves Physical Properties and Holes

Gloves meet all the specification listed in ASTM D 6319-10.

7.0 Indications of 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, Pink color, powder free and non sterile. It is equivalent, K141590,EMG Blue Nitrile Medical Examination glove Powder Free (Non Sterile) except the color

Characteristics	Acceptance Criteria	EMG Pink NitrileExamination GlovePowder Free, K161320	EMG Blue NitrileMedical ExaminationGloves (Powder Free),K141590
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 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 device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use.

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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

Material use	Not made from Natural RubberLatex.	Nitrile latex compound.	Nitrile latex compound.
Colour		Pink,color	Blue,color
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 14minUltimateElongation (%)= Min 500min		Meets ASTM D6319-10
		Meets ASTM D6319-10
	After Aging at70°C for168 hrs @100°C for 22hrs	Meets ASTM D6319-10
	Tensile Strength(MPa)= Min 14minUltimateElongation (%)= Min 400min	Meets ASTM D6319-10
Freedom from pinholes	AQL 2.5Inspection LevelG-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 on MedicalDevice -Primary Skin IrritationTest .	Test Article wasnon irritant.	Under the conditions ofthis study, the test articlewas a non-irritant.	Under the conditions of thisstudy, the test article was a non-irritant.
Biological Evaluation on MedicalDevice-Dermal Sensitization Assay .	Test Article wasnon sensitizer.	Under the conditions ofthis study, the test articlewas a non-sensitizer.	Under the conditions of thisstudy, the test article was a non-sensitizer.

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ECO Medi Glove Sdn. Bhd. (815262-D)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

(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

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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

9.0 Conclusion

Based on intended uses, technological characteristics and non - clinical performance data, the EMG Pink Nitrile Examination Glove Powder Free is substantially equivalent to the predicate device (K141590)

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.