EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

Q: Who is the manufacturer of EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

Eco Medi Glove Sdn. Bhd. filed the 510(k) submission for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (K161187).

Q: What is the FDA product code for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K161187 · Eco Medi Glove Sdn. Bhd. · LZA · Sep 9, 2016 · General Hospital

Device Facts

Record ID	K161187
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	Sep 9, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

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. It is for over-the-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, non-sterile, blue nitrile latex examination glove; worn by healthcare examiners or patients to prevent cross-contamination; provides barrier protection during handling of chemotherapy drugs. Device input is physical contact with patient or chemotherapy agents; output is a physical barrier. Used in clinical or home settings. Benefits include protection against biological contaminants and permeation resistance to specific chemotherapy drugs. Performance verified via ASTM D6319-10 (physical properties) and ASTM D6978-05 (chemotherapy permeation).

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ASTM D6319-10 for physical properties (tensile strength, elongation, dimensions, pinhole AQL 2.5) and ASTM D6978-05 for chemotherapy drug permeation. Biocompatibility confirmed via primary skin irritation and dermal sensitization assays.

Technological Characteristics

Material: Nitrile latex compound. Form: Powder-free, non-sterile, blue. Dimensions: 230mm length, 0.05mm minimum palm/finger thickness. Standards: ASTM D6319-10 (physical), 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 on the examiner's hand or finger to prevent contamination between patient and examiner, and for use during handling of chemotherapy drugs. 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

Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non Sterile, Tested for use with Chemotherapy Drugs (K141982)

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 9, 2016 Eco Medi Glove Sdn. Bhd. Suresh Kumar Ouality Assurance Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya, Industrial Estate Taiping, 34600 MY Re: K161187 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: I Product Code: LZA, LZC Dated: July 28, 2016 Received: August 11, 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 {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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use #### 510(k) Number (if known) K161187 #### Device Name EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs #### Indications for Use (Describe) A powder-free patient eaxmination 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 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. Minimum Breakthrough Detection Time (Min), ug/cm2/minute Chemotherapy Drugs and Concentration | 1) Carmustine (BCNU)(3.3mg/ml) | 1.3 minutes | |---------------------------------------|---------------| | 2) Cyclophosphamide (20mg/ml) | > 240 minutes | | 3) Cytarabine (100mg/ml) | > 240 minutes | | 4) Doxorubicin Hydrochloride (2mg/ml) | > 240 minutes | | 5) Etopside (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 | J 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) {3}------------------------------------------------ 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." {4}------------------------------------------------ formerly known as Sinetimed Consumables Sdn. Bhd. t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA, FAX +60-5-891 2999 L +60-5-891 2777 #### Appendix 2 #### 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 Kamunting Raya Industrial Estate 34600,Kamunting Perak Malaysia. | | Contact Person | : Mr Suresh Kumar | | Telephone No | : 603-60283033 | | Email | : suresh@ecomediglove.com.my | - 2.0 Preparation Date : 1st September 2016 #### 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. {5}------------------------------------------------ formerly known as Sinetimed Consumables Sdn t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 #### Appendix 2 #### 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 K141982, Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non Sterile, Tested for use with Chemotherapy Drugs #### Device Description 5.0 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 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) (Minimum) | 230 | 230 | 230 | 230 | | Width (± 5mm) | 85 | 95 | 105 | 115 | | Thickness at Palm (mm) (Minimum) | 0.05 | 0.05 | 0.05 | 0.05 | | Thickness at Finger Tip (mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 | {6}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999 ## Appendix 2 | Measurement | Before Ageing | After Aging at 70℃ for 168 hrs @ 100℃ for 22 hrs | |-------------------------|----------------------|-----------------------------------------------------| | Tensile Strength (MPa) | 14min | 14 Min | | Ultimate Elongation (%) | 500min | 400min | | | AQL 2.5 | AQL 2.5 | | Pin-hole Level | 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 Examination Gloves Powder Free with tested for use with chemotherapy drugs,K161187 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non Sterile, Tested for use with chemotherapy Drugs, K141982 | Assessment Similarities and Differences | |---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LZA and LZC | LZA and LZC | LZA and LZC | No different between subject and predicate devices. | | 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. 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. | 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. | No different between subject and predicate devices. | | Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound | No different between subject and predicate devices. | | | | | | | | Colour | Blue | Blue | Blue | No different between subject and predicate devices. | | Sterility | Non sterile | Non sterile | Non sterile | No different between subject and predicate devices. | | Single used | Single used | Single used | Single used | No different between subject and predicate devices. | | Non Sterile | Non Sterile | Non Sterile | Non Sterile | No different between subject and predicate devices. | | Dimensions | Overall Length (mm) Min 230 mm Width (± 5mm) Size S = 85mm Size M = 95mm Size L = 105mm Size XL = 115mm Thickness at Palm (mm) Min; 0.05 mm Thickness at Finger Tip (mm) Min 0.05 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Subject devices and predicate device is different on the dimension. Subject devices is having thickness at palm and finger of 0.05mm (Min) and length with 230mm (Min).Predicate devices is with thickness at palm and finger of 0.07- 0.10mm and length with min 240mm | | Physical properties | Before Ageing Tensile Strength (MPa) = 14min Ultimate Elongation (%) = 500min After Aging at 70°C for | Meets ASTM D6319-10 | Meets ASTM D6319-10 | No different between subject and predicate devices. | | | | | | | | | 168 hrs @ 100°C for 22 hrs Tensile Strength (MPa) = 14min Ultimate Elongation (%) = 400min | | | | | Freedom from pinholes | AQL 2.5 Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | No different between subject and predicate devices. | | Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 | No different between subject and predicate devices. | | Biological Evaluation on Medical Device -Primary Skin Irritation Test | | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | No different between subject and predicate devices. | | Biological Evaluation on Medical Device- Dermal Sensitization Assay | | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non- sensitizer. | No different between subject and predicate devices. | | Resistance against Chemotherapy Drugs | Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugs ASTM D6978- 05(2013) | 1) Carmustine (3.3mg/ml or 3000ppm), Minimum Breakthrough detection time : 1.3 μg/cm2/minute 2) Cyclophosphamide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 μg/cm2/minute | 1) Carmustine (3.3mg/ml or 3000ppm), Minimum Breakthrough detection time: 15 μg/cm2/minute 2) Cyclophosphamide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 μg/cm2/minute | Subject device was tested with 7 mandatory chemotherapy drugs and with addition 2 chemotherapy. Predicate device was tested with 7 mandatory chemotherapy drugs with | {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, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. FAX +60-5-891 2999 TEL +60-5-891 2777 ## Appendix 2 {8}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. FAX +60-5-891 2999 TEL +60-5-891 2777 ## Appendix 2 {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, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999 ## Appendix 2 | 3) Cytarabine (100mg/ml or 100,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | 3) Dacarbazine (10mg/ml) Minimum Breakthrough detection time: >240µg/cm²/minute | chemotherapy drugs. | | |---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--| | 4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | 4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | | | | 5) Etoposide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | 5) Etoposide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | | | | 6) Flourouracil (50mg/ml or 50,000), Minimum Breakthrough detection time: >240 µg/cm²/minute | 6) Flourouracil (50mg/ml or 50,000), Minimum Breakthrough detection time: >240 µg/cm²/minute | | | | 7) Methotrexate (25mg/ml or 25,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | 7) Cisplatin (1 mg/ml) Minimum Breakthrough detection time: >240 µg/cm²/minute | | | | 8) Paclitaxel (6mg/ml or 6,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | 8) Paclitaxel (6mg/ml or 6,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute | | | | 9) Thiotepa (10mg/ml or 10,000ppm), Minimum Breakthrough | 9) Thiotepa (10mg/ml or 10,000ppm), Minimum Breakthrough | | | | | detection time: 67.8 µg/cm²/minute | detection time: 2 µg/cm²/minute | | | | | 10) Ifosfamide (50mg/ml) Minimum Breakthrough detection time: >240 µg/cm²/minute | | | | | 11) Mitoxantrone (2mg/ml), Minimum Breakthrough detection time: >240 µg/cm²/minute | | | | | 12) Vincristine Sulfate (1mg/ml), Minimum Breakthrough detection time: >240 µg/cm²/minute | | {10}------------------------------------------------ #### BCO Medi Hove Son. Bhd. (815262-D) (formerly known as Sinetimed Consumables Sdn. Bhd.) munting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. 26. Jalan Tembaga K 0-5-891 2777 #### Appendix 2 #### 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 . 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. {11}------------------------------------------------ *(formerly known as Sinetimed Consumables Sdn. Bhd.)* 26, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA, -60-5-891 2777 #### Appendix 2 | Chemotherapy Drug and concentration | Minimum Breakthrough detection time in Minutes,µg/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) - Minimum Breakthrough detection time 1.3 μg/cm²/minute. Thiotepa (10mg/ml) - Minimum Breakthrough detection time 67.8 μg/cm²/minute. #### 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- K141982, Dermagrip Powder free Blue Nitrile Patient Examination Gloves Tested for use with chemotherapy Drugs and its does not raise different questions of safety and effectiveness. {12}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999 #### Appendix 2 #### 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 substantially equivalent to the predicate device (K141982).

EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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