Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the description and performance studies focus on physical properties and biological safety, with no mention of AI or ML.

Therapeutic

No.
The device, a patient examination glove, prevents contamination but does not treat or diagnose a disease or condition, which is the primary function of a therapeutic device.

Diagnostic

No

Explanation: The device is a patient examination glove, which is described as a disposable device to prevent contamination. Its function does not involve diagnosing medical conditions, but rather providing a barrier.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is a "powder-free patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for physical protection and hygiene.
IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This glove does not perform any such tests.
Device Description: The description focuses on the physical properties and materials of the glove, not on any diagnostic capabilities.
Lack of Diagnostic Elements: There is no mention of any components, processes, or analyses related to testing biological samples.
Performance Studies: The performance studies focus on the physical integrity and biological safety of the glove as a barrier, not on diagnostic accuracy or performance.

The information provided clearly indicates this is a Class I medical device intended for physical protection during medical examinations, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LZA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Physical properties of the gloves were evaluated against ASTM D6319-10 and ASTM D5151-06 (pinholes), ASTM D6124-06 (Residual Powder). Biological evaluation included Primary Skin Irritation Test and Dermal Sensitization Assay. The gloves met all specified acceptance criteria and were found to be non-irritant and non-sensitizer.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Tensile Strength (MPa): 14min (Before Ageing), 14 Min (After Aging)
Ultimate Elongation (%): 500min (Before Ageing), 400min (After Aging)
Pin-hole Level: AQL 2.5
Residual Powder: ≤ 2.0 mg/pc

Predicate Device(s)

K141590

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community and support. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.

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

1

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

2

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)

ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

3

(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 Kuning
Kamunting Raya Industrial Estate
34600,Kamunting Perak
Malaysia .
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 .

4

(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 :

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.

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

5

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 for
168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection 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 :

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, 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 Nitrile
Examination Glove
Powder Free, K161320 | 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. | 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. | 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. |

6

(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 Rubber
Latex. | Nitrile latex compound. | Nitrile latex compound. |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Colour | | Pink,color | Blue,color |
| Sterility | Non sterile | Non sterile | Non sterile |
| Dimensions | 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

7

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

8

(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)