EMG Pink Nitrile Examination Glove Powder Free

K161320 · Eco Medi Glove Sdn. Bhd. · LZA · Sep 1, 2016 · General Hospital

Device Facts

• Record ID: K161320
• Device Name: EMG Pink Nitrile Examination Glove Powder Free
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 1, 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 hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

Device Story

Disposable, non-sterile, powder-free patient examination glove; manufactured from nitrile latex compound. Worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical or home settings. Pink color; available in sizes S, M, L, XL. Provides protection during medical examinations.

Clinical Evidence

Bench testing only. Device meets ASTM D6319-10 specifications for dimensions, physical properties (tensile strength, elongation), and pinhole resistance (ASTM D5151-06). Biocompatibility testing (primary skin irritation and dermal sensitization) confirmed the material is non-irritant and a non-sensitizer.

Technological Characteristics

Nitrile latex compound; powder-free; non-sterile. Dimensions: 230mm min length; 0.05mm min thickness at palm/fingertip. Physical properties: 14 MPa min tensile strength; 500% min ultimate elongation (before aging). Complies with ASTM D6319-10, ASTM D5151-06, and ASTM D6124-06.

Indications for Use

Indicated for use as a disposable patient examination 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

• EMG Blue Nitrile Medical Examination Glove (Powder Free) (K141590)

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

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 [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.

# 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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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:

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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 [phone] FAX [phone]

### 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<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 : 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 [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 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 |

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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 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 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<br>Examination Glove<br>Powder Free, K161320 | EMG Blue Nitrile<br>Medical Examination<br>Gloves (Powder Free),<br>K141590 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.<br>The device is for over-the-<br>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.<br>The 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]

| Material use | Not made from Natural Rubber<br>Latex. | Nitrile latex compound. | Nitrile latex compound. |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Colour | | Pink,color | Blue,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 Ageing<br>Tensile Strength<br>(MPa)<br>= Min 14min<br><br>Ultimate<br>Elongation (%)<br>= Min 500min | | Meets ASTM D6319-10 |
| | | Meets ASTM D6319-10 | |
| | After Aging at<br>70°C for<br>168 hrs @<br>100°C for 22<br>hrs | Meets ASTM D6319-10 | |
| | Tensile Strength<br>(MPa)<br>= Min 14min<br><br>Ultimate<br>Elongation (%)<br>= Min 400min | 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 . | Test Article was<br>non irritant. | 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 . | Test Article was<br>non sensitizer. | 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. |

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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 [phone] FAX [phone]

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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]

#### 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)