EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE

K141579 · Eco Medi Glove Sdn. Bhd. · LZA · Oct 17, 2014 · General Hospital

Device Facts

• Record ID: K141579
• Device Name: EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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. It is for over-the-counter use.

Device Story

Disposable non-sterile nitrile latex examination glove; black color; powder-free. Worn by healthcare examiners on hands or fingers to provide barrier protection against contamination between patient and examiner. Device functions as a physical barrier. Used in clinical or home settings. No electronic or software components.

Clinical Evidence

Bench testing only. Device meets ASTM D6319-10 for dimensions, physical properties (tensile strength, elongation), and pinhole levels (AQL 2.5). Biocompatibility testing (primary skin irritation and dermal sensitization) confirmed the material is non-irritant and a non-sensitizer.

Technological Characteristics

Material: Nitrile latex compound. Form: Powder-free, non-sterile, black color. Dimensions: 230mm length, 0.05mm minimum thickness at palm/fingertip. Standards: ASTM D6319-10 (physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Suitable for over-the-counter use.

Regulatory Classification

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.

Predicate Devices

• RS Black Nitrile Medical Examination Gloves Powder Free (Non-Sterile) (K112924)

Submission Summary (Full Text)

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

October 17, 2014

Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan, Malaysia 34600

Re: K141579

Trade/Device Name: EMG Black Nitrile Medical Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 10, 2014 Received: September 12, 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 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.

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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 (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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director 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) K141579

Device Name

EMG Black Nitrile Medical Examination Glove Powder Free

Indications for Use (Describe)

A Powder Free Patient examination gloves is a disposable device intended for medical purpose 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 C nsumables Sdn. Bhd.

t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. L [phone] FAX [phone]

> APPENDIX 2 510K#:141579

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

### 1.0 Submitter :

| Company Name | : ECO MEDI GLOVE SDN. BHD. |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Company Address | : Lot 23826,Jalan Tembaga Kuning<br>Kamunting Raya Industrial Estate<br>34600,Kamunting Perak<br>Malaysia . |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| Email | : [e-mail] |

- 2.0 Preparation Date : 03th October 2014 .
### 3.0 Name of the Device

Trade Name / Proprietary Name : EMG Black 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 .

Section 2A-1

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as Sinetimed (

t 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL [phone]

> APPENDIX 2 510K#:141579

## 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 K112924, RS Black Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) .

### 5.0 Description of Device :

Black 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, Black colour, powder free and non sterile.

### 6.0 Executive summary :

EMG Black Nitrile Medical Examination Glove Powder Free is a disposable glove made of nitrile latex compound Black colour powder free. This Black 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 .

# 6.1.1.1 Dimension and Thickness of Gloves .

6.1.1 Specification for Nitrile 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 |

Section 2A-2

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*(formerly known as Sinetimed Consumables Sdn. Bhd.)*

t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALA YSIA. TEL [phone] FAX [phone]

> APPENDIX 2 510K#:141579

| Measurement | Before Ageing | After Aging at 70 °C for<br>168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|---------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>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 Intended use of the Device :

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. 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, Black colour, powder free and non sterile. It is equivalent to K 112924, RS Black Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) .

| Characteristics | Acceptance Criteria | EMG Black Nitrile<br>Medical Examination<br>Gloves<br>Powder Free, K141579 | RS Black Nitrile Medical<br>Examination Gloves<br>Powder Free<br>(Non-Sterile) K112924 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA | LZA |
| Intended use | A powder free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner. The device is<br>for over-the-counter use. | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use. | A powder free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over-the-<br>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 [phone] FAX [phone]

### APPENDIX 2 510K#:141579

| Material use | Not made from Natural Rubber<br>Latex. | Nitrile latex compound. | Nitrile latex compound. | | Before Ageing | | |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------|---------------------|-------------------------------------------------------|---------------------|---------------------|
| Colour | Black | Black | Black | | Tensile Strength (MPa)<br>= Min 14min | | Meets ASTM D6319-10 |
| Sterility | Non sterile | Non sterile | Non sterile<br>Section 2A-3 | | Ultimate Elongation (%)<br>= Min 500min | | |
| Dimensions | Overall Length (mm)<br>= Min 230mm<br>Width (± 5mm)<br>Size S = 85mm<br>Size M = 95mm<br>Size L = 105mm<br>Size XL = 115mm<br>Thickness at Palm (mm)<br>= Min 0.05min<br>Thickness at Finger Tip (mm)<br>= Min 0.05min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Physical properties | After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs | Meets ASTM D6319-10 | |
| | Tensile Strength (MPa)<br>= Min 14min<br>Ultimate Elongation (%)<br>= Min 400min | | | | | | |

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#### ECO Medi ( (815262-D)

(formerly known as Sinetimed ( umables S

Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL [phone] FAX [phone]

### APPENDIX 2 510K#:141579

| Freedom from pinholes | AQL 2.5<br>Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
|-----------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Residual Powder | $\leq$ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biological Evaluation on<br>Medical Device -<br>Primary Skin Irritation<br>Test . | Test Article was non irritant. | Under the conditions of<br>this study, the test article<br>was a non-irritant . | Under the conditions of<br>this study, the test article<br>was a non-irritant . |
| Biological Evaluation on<br>Medical Device-<br>Dermal Sensitization<br>Assay . | Test Article was non<br>sensitizer. | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. |

# 9.0 Conclusion

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

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

properties, technological characteristics and non-clinical performance .

Section 2A-5