EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs

K171339 · Eco Medi Glove Sdn. Bhd. · LZA · Jul 7, 2017 · General Hospital

Device Facts

• Record ID: K171339
• Device Name: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 7, 2017
• 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 and for use with chemotherapy drugs. In addition these gloves were tested for use with chemotherapy drugs in accordance ASTM D6978-05 standards- Practice for assessment of Medical Glove to Permeation by chemotherapy drugs

Device Story

Disposable, non-sterile, blue nitrile latex examination glove; worn by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; provides a physical barrier between patient and examiner. Benefits include protection against patient-to-examiner contamination and exposure to hazardous chemotherapy agents.

Clinical Evidence

Bench testing only. Includes physical property testing (tensile strength, elongation), pinhole testing (ASTM D5151-06), residual powder testing (ASTM D6124-06), and chemotherapy drug permeation testing (ASTM D6978-05). Biocompatibility testing performed per ISO 10993-10:2010 (primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Nitrile latex compound. Form: Powder-free, non-sterile, blue, disposable. Standards: ASTM D6319-10 (physical properties), ASTM D6978-05 (chemotherapy permeation), ISO 10993-10 (biocompatibility). Dimensions: 230mm length, 0.05mm minimum palm/finger thickness.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner, and for use during handling of chemotherapy drugs.

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 Examination Glove Powder Free with tested for use with Chemotherapy Drugs (K161187)

Submission Summary (Full Text)

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Public Health Service

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July 7, 2017

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

ECO Medi Glove Sdn. Bhd. Suresh Kumar Official Correspondent Lot 23826. Jalan Tembaga Kuning Kamunting Raya Industrial Estate Kamunting Perak, 34600 Malaysia

Re: K171339

Trade/Device Name: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 15, 2017 Received: May 19, 2017

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

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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 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,

# Mark S. Fellman -S

for

Lori A. Wiggins, MPT, CLT Acting 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) K171339

#### Device Name

EMG Blue Nitrile Examination Glove Powder Free with tested for use with Chemotherapy Drugs

Indications for Use (Describe)

A powder-free patient examination glove is a disposable device intended for use medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and use for use with chemotherapy drugs.

In addition these gloves were tested for use with chemotherapy drugs in accordance ASTM D6978-05 standards- Practice for assessment of Medical Glove to Permeation by chemotherapy drugs

Chemotherapy Drugs and Concentration

Minimum Breakthrough Detection Time(Min),ug/cm2/minutes

| 1) Carmustine (BCNU)(3.3 mg/ml) | 24.0 Minutes |
|--------------------------------------|---------------|
| 2)Cyclophoshamide (20 mg/ml) | > 240 Minutes |
| 3)Doxorubicin Hydrochloride (2mg/ml) | > 240 Minutes |
| 4)Etoposide (20mg/ml) | > 240 Minutes |
| 5)Fluorouracil (50mg/ml) | > 240 Minutes |
| 6)Methorexate (25mg/ml) | > 240 Minutes |
| 7)Paclitaxel (6mg/ml) | > 240 Minutes |
| 8)Thiotepa (10mg/ml) | 56.9 Minutes |
| 9)Carboplatin (10mg/ml) | > 240 Minutes |
| 10)Cisplatin (1 mg/ml) | > 240 Minutes |
| 11)Dacarabazine (1 mg/ml) | > 240 Minutes |
| 12)Ifosfamide (5 mg/ml) | > 240 Minutes |
| 13)Mitomycin (0.5mg/ml) | > 240 Minutes |
| 14)Mitoxantrone (2 mg/ml) | > 240 Minutes |
| 15)Vincristine Sulfate (1 mg/ml) | > 240 Minutes |

The Maximum testing is 240 minutes. Please note that the following drugs have extremely low Permeation time, Carmustine (BCNU)(3.3 mg/ml) - Minimum breakthrough detection time : 24.0 minutes Thiotepa (10mg/ml) - Minimum breakthrough detection time : 56.9 minutes

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

## 510(K) Summary EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

### 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 : 4th July 2017
## 3.0 Name of the Device

Trade Name / Proprietary Name : EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs.

Device Name : Nitrile Patient Examination gloves.

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

Device Class : Class I.

Product Code : Nitrile-LZA and LZC.

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

amunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. [phone]

#### 4.0) Identification of The Legally Marketed Device :

EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs.LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K161187, EMG Blue Nitrile Examination Glove Powder Free with tested for use with Chemotherapy Drugs.

#### 5.0 Device Description

The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.

The Blue 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).

| Dimension | Size S | Size M | Size L | Size XL |
|------------------------------------------|--------|--------|--------|---------|
| Overall Length (mm) (Minimum) | 230 | 230 | 230 | 230 |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm)<br>(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
| Thickness at Finger Tip<br>(mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |

### 6.1 Specification for Nitrile gloves: 6.2 Dimension and Thickness of Gloves

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#### ECO Medi 5262-D)

(for

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

| 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 | AQL 2.5 |
| | Inspection Level G-1 | Inspection Level G-1 |

# 6.1.2 Gloves Physical Properties and Holes

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

| Characteristics | Acceptance Criteria | EMG Blue Nitrile<br>Examination Gloves<br>Powder Free with<br>tested for use with<br>chemotherapy drugs.<br>K171339 | EMG Blue Nitrile<br>Examination Gloves,<br>Powder Free with<br>tested for use with<br>chemotherapy drugs,<br>K161187 | Comparison | | | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Product Code | LZA and LZC | LZA and LZC | LZA and LZC | Same | | | | |
| Intended use | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use.<br>Intended 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<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. | Same | | | | |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound | Same | | | | |
| Color | Blue | Blue | Blue | Same | | | | |
| Sterility | Non sterile | Non sterile | Non sterile | Same | | | | |
| Single used | Single used | Single used | Single used | Same | | | | |
| | | | | | | | | |
| Dimensions | Overall Length (mm)<br>Min 230 mm<br>Width (± 5mm)<br>Size S = <b>85mm</b><br>Size M = <b>95mm</b><br>Size L = <b>105mm</b><br>Size XL = <b>115mm</b><br>Thickness at Palm (mm)<br>Min; 0.05 mm<br>Thickness at Finger Tip (mm)<br>Min 0.05 mm | Size : Medium<br>Palm Width: 98 mm<br>Length : 247 mm<br>Finger Thickness : 0.08mm<br>Palm Thickness : 0.05mm<br>Meets ASTM D6319-10 | Size : Medium<br>Palm Width: 99 mm<br>Length : 247 mm<br>Finger Thickness : 0.11mm<br>Palm Thickness : 0.07mm<br>Meets ASTM D6319-10 | Same | | | | |
| Physical<br>properties | <b>Before Ageing</b><br>Tensile Strength (MPa)<br>= Min 14 Mpa<br>Ultimate Elongation (%)<br>= Min 500 %<br><b>After Aging at 70°C for<br/>168 hrs @ 100°C for<br/>22 hrs</b><br>Tensile Strength (MPa)<br>= Min 14 Mpa<br>Ultimate Elongation (%)<br>= Min 400 % | Tensile strength (Mpa) :<br>Before aging : 25.45Mpa<br>After Accelerated aging:<br>26.33Mpa<br>Ultimate Elongation(%):<br>Before aging:600%<br>After aging : 550%<br>Meets ASTM D6319-10 | Tensile strength (Mpa) :<br>Before aging : 25.45Mpa<br>After Accelerated aging:<br>26.33Mpa<br>Ultimate Elongation(%):<br>Before aging:600%<br>After aging : 550%<br> | Same | | | | |
| | Freedom from<br>pinholes | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Meets ASTM D5151-06 | AQL 2.5<br>Meets ASTM D5151-06 | | | | |
| | Residual<br>Powder | < 2.0 mg/glove | Average 0.17 mg/glove<br>Meets ASTM D6124-06 | Average 0.19 mg/glove<br>Meets ASTM D6124-06 | | | | |
| | Biological<br>Evaluation on<br>Medical Device<br>-Primary Skin<br>Irritation Test | ISO 10993-10:2010 | 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<br>Evaluation on<br>Medical<br>Device-<br>Dermal<br>Sensitization<br>Assay | ISO 10993-10:2010 | 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. |
| | | | | | | | | |

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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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## 510K No : K171339

# 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]

{9}------------------------------------------------

# 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]

| 7) Methorexate<br>(25mg/ml or<br>25,000ppm),<br>Minimum Breakthrough<br>detection time: > 240<br>minutes | 9) Thiotepa (10mg/ml or<br>10,000ppm),<br>Breakthrough time: 67.8<br>minutes. | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--|
| 8) Paclitaxel (6mg/ml or<br>6,000ppm),<br>Minimum Breakthrough<br>detection time:<br>>240minutes | | |
| 9) Thiotepa (10mg/ml or<br>10,000ppm),<br>Minimum Breakthrough<br>detection time:<br>56.9 minutes | | |
| 10) Ifosfamide<br>(50mg/ml)<br>Minimum Breakthrough<br>detection time: >240<br>minutes | | |
| 11) Mitoxantrone<br>(2mg/ml) ,<br>Minimum Breakthrough<br>detection time: >240<br>minutes | | |
| 12) Vincristine Sulfate<br>(1mg/ml) ,<br>Minimum Breakthrough<br>detection time: >240<br>minutes | | |
| 13) Carboplatin<br>(10.0mg/ml), Minimum<br>Breakthrough detection<br>time: >240 minutes | | |
| | 14) Dacarbazine (DTIC)<br>(10.0mg/ml) Minimum<br>Breakthrough detection<br>time: >240 minutes | |
| | 15) Mitomicin C<br>(0.5mg/ml) Minimum<br>Breakthrough detection<br>time: >240 minutes | |

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(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]

### 7.0 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 and for use with chemotherapy drugs .

In addition these gloves were tested for use with Chemotherapy drugs in accordance With ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

| Chemotherapy Drug and concentration | Minimum Breakthrough detection time in Minutes,µg/cm²/minute |
|---------------------------------------|--------------------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml) | 24 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (10mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 56.9 minutes |
| 10) Cisplatin (1.0mg/ml) | > 240 minutes |

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

Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA.

| 11) Dacarbazine (DTIC) (10.0mg/ml) | > 240 minutes |
|------------------------------------|---------------|
| 12) Ifosfamide (50.0mg/ml) | > 240 minutes |
| 13) Mitomycin C (0.5mg/ml) | > 240 minutes |
| 14) Mitoxantrone (2.0mg/ml) | > 240 minutes |
| 15) Vincristine Sulfate (1.0mg/ml) | > 240 minutes |

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time,

Carmustine (BCNU) (3.3mg/ml) - Minimum Breakthrough detection time 24 Minutes

Thiotepa (10mg/ml) - Minimum Breakthrough detection time 56.9 minutes.

## 8.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion

There are no differences in technological characteristics of the subject device compare with the predicate device.

The gloves are made from nitrile latex compound, Blue color, Powder free and nonsterile. The gloves met all the specifications in ASTM D6319-10 Standard specification for Nitrile Examination Gloves as well Biological Evaluation on medical device. Additionally, the gloves have been tested for permeability to Chemotherapy drugs.

### 9.0 Conclusion

Based on intended uses, technological characteristics and non - clinical performance Data, the EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs is as safe, as effective, and performs as well as the legally marketed predicate device, K161187.