(135 days)
Not Found
No
The 510(k) summary describes a standard medical examination glove and its testing against relevant ASTM standards and chemotherapy drug permeability. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is a patient examination glove, which is a barrier device for contamination prevention, not a therapeutic device designed to treat or cure a medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination and for use with chemotherapy drugs, not to diagnose a condition.
No
The device described is a physical medical device (examination gloves) and does not mention any software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as 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." This describes a barrier device used externally on the body.
- Device Description: The description reinforces this, calling it a "patient examination glove" made from nitrile.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function. It is a physical barrier.
- Relevant Standards: The standards mentioned (ASTM D6319-10 and ASTM D6978-05) relate to the physical properties and chemical resistance of examination gloves, not to diagnostic testing.
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
Minimum Breakthrough Detection Time (Min), ug/cm2/minute for specific Chemotherapy Drugs and Concentration:
- Carmustine (BCNU)(3.3mg/ml): 1.3 minutes
- Cyclophosphamide (20mg/ml): > 240 minutes
- Cytarabine (100mg/ml): > 240 minutes
- Doxorubicin Hydrochloride (2mg/ml): > 240 minutes
- Etopside (20mg/ml): > 240 minutes
- Fluorouracil (50mg/ml): > 240 minutes
- Methorexate (25mg/ml): > 240 minutes
- Paclitaxel (6mg/ml): > 240 minutes
- Thiotepa (10mg/ml): 67.8 minutes
Physical properties:
Before Ageing: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 500min
After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 400min
Pin-hole Level: AQL 2.5, Inspection Level G-1. Meets ASTM D5151-06.
Residual Powder:
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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
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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 |
: 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).