EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

K152937 · Eco Medi Glove Sdn. Bhd. · LZA · Jun 23, 2016 · General Hospital

Device Facts

• Record ID: K152937
• Device Name: EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner

Device Story

Disposable, non-sterile, blue nitrile examination glove; peppermint scented. Worn by healthcare examiners on hands or fingers to provide a barrier against contamination between patient and examiner. Manufactured from nitrile latex compound. Used in clinical settings. Provides physical barrier protection; performance verified against ASTM standards for tensile strength, elongation, and pinhole resistance. Biocompatibility testing confirms non-irritant and non-sensitizing properties.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (pinholes), and ASTM D6124-06 (residual powder). Biocompatibility testing per ISO 10993-10:2010 confirmed the device is a non-irritant and non-sensitizer.

Technological Characteristics

Material: Nitrile latex compound. Form factor: Disposable, non-sterile, blue, peppermint-scented glove. Dimensions: 230mm length; 0.05mm min thickness. Standards: ASTM D6319-10 (physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-10 (non-irritant, non-sensitizer).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

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

• Powder Free Nitrile Examination Glove, Peppermint Scented, blue Color (K070097)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

June 23, 2016

Eco Medi Glove Sdn. Bhd. Mr. Suresh Kumar Official Correspondent Lot 23826. Jalan Tembaga Kuning. Kamunting Raya Industrial Estate Taiping Perak, 34600 MALAYSIA

Re: K152937

Trade/Device Name: EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 2, 2016 Received: May 13, 2016

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. Isting 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 [phone] or [phone] 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 [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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K152937

#### Device Name

EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint scented

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 hands 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)

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

{3}------------------------------------------------

# ECO Medi Glove Sdn

ables merly known as Sinetimed

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

## 510(K) Summary EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented.

#### 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 : 2nd June 2016 .
#### 3.0 Name of the Device

Trade Name / Proprietary Name : EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

Device Name : Nitrile Patient Examination gloves .

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

Device Class : Class I .

Product Code : LZA .

{4}------------------------------------------------

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

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

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

### 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 K070097.Powder Free Nitrile Examination Glove, Peppermint Scented , blue Color

#### 5.0 Description of Device :

Blue Nitrile Examination gloves powder free with Peppermint Scented , 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, Blue color, Powder free and non sterile.

#### 6.0 Executive summary :

EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is a disposable glove made of nitrile latex compound Blue color powder free. This Blue Nitrile Examination Gloves Powder Free with Peppermint Scented 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 .

| 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 |

### 6.1.1 Specification for Nitrile gloves: 6.1.1.1 Dimension and Thickness of Gloves .

Section 2A-2

{5}------------------------------------------------

#### BCO Medi Glo . Bhd. (815262-D)

(formerly known as Sinetimed Consumables Sdn. Bhd.)

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

| Measurement | Before Aging | 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 glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner .

## 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, Blue color, powder free and non sterile. It is equivalent to K070097,Powder Free Nitrile Examination Glove, Peppermint Scented, blue Color

| Characteristics | Acceptance Criteria | EMG Powder Free<br>Nitrile Examination<br>Glove (Blue) with<br>Peppermint Scented | Powder Free Nitrile<br>Examination Glove,<br>Peppermint Scented ,<br>blue Color<br>510K#:070097 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | 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. |

{6}------------------------------------------------

# 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, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. FAX [phone] TEL [phone]

| | The device is for over-the-<br>counter use. | The device is for over-<br>the-counter use. | The device is for over-the-<br>counter use. | |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Material use | Not made from Natural Rubber<br>Latex. | Nitrile latex compound. | Nitrile latex compound. | |
| Colour | Peppermint Scented , blue<br>Color | Peppermint Scented ,<br>blue Color | Peppermint Scented , blue<br>Color | |
| Sterility | Non sterile | Non sterile | Non sterile | |
| 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 | Before Aging<br>Tensile Strength<br>(MPa)<br>= Min 14min<br><br>Ultimate<br>Elongation (%)<br>= Min 500min<br><br>After Aging at<br>70°C for<br>168 hrs @<br>100°C for 22<br>hrs<br><br>Tensile Strength<br>(MPa)<br>= Min 14min<br><br>Ultimate<br>Elongation (%)<br>= Min 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | |
| | Freedom from pinholes | AQL 2.5<br>Inspection Level<br>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 on Medical<br>Device -Primary Skin Irritation<br>Test . | The test article<br>is a non-irritant<br>per ISO 10993-<br>10. | Under the conditions of<br>this study, the test article<br>was a non-irritant. | Under the conditions of this<br>study, the test article was a non-<br>irritant. |
| Biological Evaluation on Medical<br>Device-<br>Dermal Sensitization Assay . | The test article<br>is a non-<br>sensitizer per<br>ISO 10993-10. | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. | Under the conditions of this<br>study, the test article was a non-<br>sensitizer. | |

Section 2A-4

{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 [phone] FAX [phone]

Section 2A-5

{8}------------------------------------------------

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

(formerly known as Sinetimed Consumables Sdn. Bhd.

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

#### 9.0) Substantial Equivalent Based on Assessment of Non-Clinical Performance data

Performance testing was completed in accordance with ASTM D6319-10 , ASTM D5151-06, and ASTM D6124-06. The glove meet standards requirement referenced in section 6.0 above. Biocompatibility testing per ISO 10993-10:2010 indicates that the subject gloves are non-sensitizing and non-irritating under the conditions tested

#### 9.0 Conclusion

The conclusions drawn from the nonclinical and clinical tests demonstrate that EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented is as safe, as effective, and performs as well as the legally marketed predicate device K070097 Powder Free Nitrile Examination Glove, Peppermint Scented, Blue Color