EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM

K141623 · Eco Medi Glove Sdn. Bhd. · LZA · Oct 7, 2014 · General Hospital

Device Facts

• Record ID: K141623
• Device Name: EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 7, 2014
• 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 . It is for overthe-counter use. 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.

Device Story

Disposable blue nitrile examination glove; worn on examiner's hand/fingers to provide barrier protection against contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical or medical settings; intended for over-the-counter use. Provides physical barrier; protects healthcare personnel from exposure to chemotherapy agents during handling. Benefits include reduced risk of cross-contamination and chemical exposure.

Clinical Evidence

Bench testing only. Includes physical property testing (tensile strength, elongation), pinhole testing (AQL 2.5), biocompatibility (primary skin irritation, dermal sensitization), and chemotherapy drug permeation testing per ASTM D6978-05. No clinical data.

Technological Characteristics

Material: Nitrile latex compound. Form: Blue, powder-free, non-sterile examination glove. Standards: ASTM D6319-10 (physical properties/dimensions), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder).

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners 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

• Cornflower Powder Free Exam glove tested for use with Chemotherapy Drugs (K110921)

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 7,2014

Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23836, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Kamunting Perak, Malaysia 34600

Re: K141623

Trade/Device Name: EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs Labeling Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 5, 2014 Received: September 5, 2014

Dear Mr. 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.

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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,

Susan Runno DDS, MA

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) K141623

#### Device Name

EMG Blue Nitrile Examination Gloves Powder Free with Chemotherapy Drues

#### Indications for Use (Describe)

A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers 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, 0.01µg/cm²/minute |
|---------------------------------------|-------------------------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml) | 1.3 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (100mg/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) | 67.8 minutes |

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time : Carmustine (BCNU) (3.3mg/ml)

Thiotepa (10mg/ml)

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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formerly known as Sinetimed Consumables Sdn. Bhd.

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

> Appendix 2 (510k#: K141623)

## 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 |

- : [e-mail]
- 2.0 Preparation Date : 23rd September 2014

#### 3.0 Name of the Device

Email

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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nerly known as Sinetimed Consumables Sdn. Bhd.

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

> Appendix 2 (510k#: K141623)

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

Class I patient Examination glove with tested for use with Chemotherapy Drugs, Powder Free,LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K110921, Cornflower Powder Free Exam glove tested for use with Chemotherapy Drugs (Non sterile) .

#### Device Description 5.0

The subject device in this 510(k) Notification is 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 colour, 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).

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

| Dimension | Size S | Size M | Size L | Size XL |
|------------------------------|---------|---------|---------|---------|
| Overall Length (mm) | 270min | 270min | 270min | 270min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
| Thickness at Finger Tip (mm) | 0.10min | 0.10min | 0.10min | 0.10min |

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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#: K141623)

## 6.1.2 Gloves Physical Properties and Holes

| 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 |

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

| Characteristics | Acceptance Criteria | EMG Blue Nitrile<br>Medical Examination<br>Gloves Powder Free<br>with tested for use with<br>chemotherapy drugs<br>(K141623) | Nitrile Cornflower Blue<br>Powder Free gloves tested<br>for use with<br>Chemotherapy drugs<br>(Non-Sterile ), K110921 |
|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZC | LZC | LZC |
| 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<br>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. |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound |
| Colour | Blue | Blue | Blue |
| Sterility | Non sterile | Non sterile | Non sterile |
| Single used | Single used | Single used | Single used |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile<br>Section 2A-3 |
| | Appendix 2<br>(510k#: K141623) | | |
| Dimensions | Overall Length (mm)<br>Min 270mm<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; 0.10mm<br>Thickness at Finger Tip (mm)<br>Min 0.10 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical properties | Before Ageing<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 500min<br>After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs<br>Tensile Strength (MPa)<br>= 14min<br>Ultimate Elongation (%)<br>= 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from pinholes | AQL 2.5<br>Inspection Level 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<br>Medical Device -<br>-Primary Skin Irritation<br>Test | | 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 | | 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. |
| Resistance against<br>Chemotherapy Drugs | | 1) Carmustine (3.3mg/ml<br>or 3000ppm),<br>Breakthrough : 1.3 min. | 1) Carmustine (3.3mg/ml<br>or 3000ppm),<br>Breakthrough : 4.5min.<br>Section 2A-4 |
| | | Appendix 2<br>(510k#: K141623) | |
| Standards Practice for<br>Assessment of resistance of<br>Medical Glove to Permeation<br>by Chemotherapy drugs<br>ASTM D6978-05(2013) | 2) Cyclophosphamide<br>(20mg/ml or<br>20,000ppm),<br>Breakthrough time :<br>>240 min. | 2) Cyclophosphamide<br>(20mg/ml or 20,000ppm),<br>Breakthrough time : >240<br>min.<br>3) Cytarabine (100mg/ml<br>or 100,000ppm),<br>Breakthrough time : >240<br>min. | |
| | 3) Cytarabine (100mg/ml<br>or 100,000ppm),<br>Breakthrough time :<br>>240 min. | 4)Doxorubicin<br>Hydrochloride (2.0mg/ml<br>or 2000ppm),<br>Breakthrough time : >240<br>min. | |
| | 4)Doxorubicin<br>Hydrochloride (2.0mg/ml<br>or 2000ppm),<br>Breakthrough time :<br>>240 min. | 5) Etoposide (20mg/ml or<br>20,000ppm), Breakthrough<br>time : >240 min. | |
| | 5) Etoposide (20mg/ml<br>or 20,000ppm),<br>Breakthrough time :<br>>240 min. | 6) Flourouracil (50mg/ml<br>or 50,000), Breakthrough<br>time : >240 min. | |
| | 6) Flourouracil (50mg/ml<br>or 50,000), Breakthrough<br>time : >240 min. | 7) Methorexate (25mg/ml<br>or 25,000ppm),<br>Breakthrough time : > 240<br>min. | |
| | 7) Methorexate (25mg/ml<br>or 25,000ppm),<br>Breakthrough time : ><br>240 min. | 8) Paclitaxel (6mg/ml or<br>6,000ppm), Breakthrough<br>time : >240 min. | |
| | 8) Paclitaxel (6mg/ml or<br>6,000ppm),<br>Breakthrough time :<br>>240 min. | 9) Thiotepa (10mg/ml or<br>10,000ppm), Breakthrough<br>time : 6.88 min. | |
| | 9) Thiotepa (10mg/ml or<br>10,000ppm),<br>Breakthrough time : 67.8<br>min. | | |

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

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

(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}------------------------------------------------

(formerly known as Sinetimed Consumables Sdn. Bhd.)

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

> Appendix 2 (510k#: K141623)

#### 7.0 Intended use of the Device

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 . It is for overthe-counter use.

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<br>in Minutes,0.01µg/cm²/minute |
|---------------------------------------|---------------------------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml) | 1.3 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (100mg/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) | 67.8 minutes |

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

Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)

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

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

> Appendix 2 (510k#: K141623)

#### 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 colour, 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.

Based on the intended uses, physical properties and technological characteristics, the subject device is as safe and effective as a legally marketed device- K110921, Nitrile Cornflower Blue Powder Free Exam Gloves Medical Exam tested for use with Chemotherapy Drugs test, and its does not raise different questions of safety and effectiveness.

#### 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 (K141623) is substantially equivalent to the predicate device (K110921).