(60 days)
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
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 document describes the acceptance criteria and performance of the "EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs." This is a medical device, not an AI/ML device, so many of the requested fields are not applicable.
Here's the information extracted and formatted as requested, with "N/A" for fields that are not relevant to this type of device:
Acceptance Criteria and Device Performance for EMG Blue Nitrile Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria | Reported Device Performance (K171339) | Comparison to Predicate (K161187) |
|---|---|---|---|
| Product Code | LZA and LZC | LZA and LZC | Same |
| 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 with chemotherapy drugs in accordance with ASTM D6978-05. | 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 with chemotherapy drugs in accordance with ASTM D6978-05. | Same |
| Material Use | Nitrile latex compound | Nitrile latex compound | Same |
| Color | Blue | Blue | Same |
| Sterility | Non sterile | Non sterile | Same |
| Single Use | Single used | Single used | Same |
| 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 | Size: Medium Palm Width: 98 mm Length: 247 mm Finger Thickness: 0.08mm Palm Thickness: 0.05mm (Meets ASTM D6319-10) | Size: Medium Palm Width: 99 mm Length: 247 mm Finger Thickness: 0.11mm Palm Thickness: 0.07mm (Meets ASTM D6319-10) Overall dimensions are considered "Same" for substantial equivalence based on meeting the ASTM standard. |
| Physical Properties | Before Ageing: Tensile Strength (MPa) = Min 14 Mpa, Ultimate Elongation (%) = Min 500 % After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = Min 14 Mpa, Ultimate Elongation (%) = Min 400 % | Tensile strength (Mpa): Before aging: 25.45Mpa, After Accelerated aging: 26.33Mpa Ultimate Elongation(%): Before aging: 600%, After aging: 550% (Meets ASTM D6319-10) | Tensile strength (Mpa): Before aging: 25.45Mpa, After Accelerated aging: 26.33Mpa Ultimate Elongation(%): Before aging: 600%, After aging: 550% (Meets ASTM D6319-10) This indicates the predicate also met these criteria, confirming "Same". |
| Freedom from Pinholes | AQL 2.5 (Inspection Level G-1) | AQL 2.5 (Inspection Level G-1) | AQL 2.5 (Meets ASTM D5151-06) The device meets the same AQL and inspection level. |
| Residual Powder | < 2.0 mg/glove | Average 0.17 mg/glove (Meets ASTM D6124-06) | Average 0.19 mg/glove (Meets ASTM D6124-06) Both devices meet the acceptance criteria and demonstrate similar performance. |
| Biological Evaluation (Primary Skin Irritation) | ISO 10993-10:2010 compliance for non-irritant | 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. Both devices show non-irritant properties. |
| Biological Evaluation (Dermal Sensitization Assay) | ISO 10993-10:2010 compliance for non-sensitizer | 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. Both devices show non-sensitizer properties. |
| Chemotherapy Drug Permeation (ASTM D6978-05) - Selected Examples | Carmustine (BCNU)(3.3 mg/ml): Minimum Breakthrough detection time: > 24.0 MinutesCyclophosphamide (20 mg/ml): Minimum Breakthrough detection time: > 240 MinutesThiotepa (10mg/ml): Minimum Breakthrough detection time: > 56.9 Minutes(Note: Max testing time is 240 minutes) | Carmustine (BCNU)(3.3 mg/ml): 24 minutesCyclophosphamide (20 mg/ml): > 240 minutesThiotepa (10mg/ml): 56.9 minutesList includes 15 drugs, with most showing >240 minutes breakthrough time. Specific values for Carmustine and Thiotepa are noted as having low permeation time. | The Indications for Use section (pages 2-3 and 10-11) lists the same 15 chemotherapy drugs and concentrations with identical "Minimum Breakthrough Detection Time" values for both the subject device (K171339) and the predicate (K161187) (as detailed on page 2 and stated in the comparison for substantial equivalence). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Physical/Chemical Tests: Not explicitly stated as a single number. The testing is based on ASTM standards (D6319-10, D5151-06, D6124-06) which prescribe sampling plans for quality control (e.g., AQL for pinholes).
- Sample Size for Chemotherapy Permeation: Not explicitly stated. ASTM D6978-05, the standard referenced, outlines the methodology for testing permeation, which would involve multiple samples.
- Data Provenance: The testing was conducted to meet established ASTM and ISO standards. The manufacturer is ECO MEDI GLOVE SDN. BHD. based in Malaysia. The tests appear to be prospective for the purpose of demonstrating substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: This is a physical device, and its performance is measured against objective standards (ASTM, ISO) and laboratory tests, not subjective expert judgment for ground truth establishment.
4. Adjudication method for the test set:
- N/A: Not applicable for objective physical and chemical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A: This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This is not an AI/ML device. The "standalone" performance refers to the glove's physical and chemical properties.
7. The type of ground truth used:
- Objective Standards and Laboratory Measurements: The "ground truth" for this device is based on its ability to meet the specifications outlined in recognized international standards (ASTM D6319-10 for nitrile gloves, ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151-06 for pinholes, ASTM D6124-06 for residual powder, and ISO 10993-10 for biocompatibility). These are quantifiable, objective measurements.
8. The sample size for the training set:
- N/A: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A: There is no "training set" for this type of device.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 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 facing to the right.
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
{1}------------------------------------------------
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 (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,
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
{2}------------------------------------------------
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.
{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.)
Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. +60-5-891 2777 FAX +60-5-891 2000
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 KuningKamunting Raya Industrial Estate,34600, Kamunting PerakMalaysia. |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| : suresh@ecomediglove.com.my |
- 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.
{5}------------------------------------------------
(formerly known as Sinetimed Consumables Sdn. Bhd.)
amunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. +60-5-891 2777
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)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
| Thickness at Finger Tip(mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
6.1 Specification for Nitrile gloves: 6.2 Dimension and Thickness of Gloves
{6}------------------------------------------------
ECO Medi 5262-D)
(for
Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
| Measurement | Before Ageing | After Aging at 70 °C for168 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 NitrileExamination GlovesPowder Free withtested for use withchemotherapy drugs.K171339 | EMG Blue NitrileExamination Gloves,Powder Free withtested for use withchemotherapy drugs,K161187 | Comparison | ||||
|---|---|---|---|---|---|---|---|---|
| Product Code | LZA and LZC | LZA and LZC | LZA and LZC | Same | ||||
| Intended use | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use.Intended use. | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use. | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.The device is for over-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)Min 230 mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)Min; 0.05 mmThickness at Finger Tip (mm)Min 0.05 mm | Size : MediumPalm Width: 98 mmLength : 247 mmFinger Thickness : 0.08mmPalm Thickness : 0.05mmMeets ASTM D6319-10 | Size : MediumPalm Width: 99 mmLength : 247 mmFinger Thickness : 0.11mmPalm Thickness : 0.07mmMeets ASTM D6319-10 | Same | ||||
| Physicalproperties | Before AgeingTensile Strength (MPa)= Min 14 MpaUltimate Elongation (%)= Min 500 %After Aging at 70°C for168 hrs @ 100°C for22 hrsTensile Strength (MPa)= Min 14 MpaUltimate Elongation (%)= Min 400 % | Tensile strength (Mpa) :Before aging : 25.45MpaAfter Accelerated aging:26.33MpaUltimate Elongation(%):Before aging:600%After aging : 550%Meets ASTM D6319-10 | Tensile strength (Mpa) :Before aging : 25.45MpaAfter Accelerated aging:26.33MpaUltimate Elongation(%):Before aging:600%After aging : 550% | Same | ||||
| Freedom frompinholes | AQL 2.5Inspection Level G-1 | AQL 2.5Meets ASTM D5151-06 | AQL 2.5Meets ASTM D5151-06 | |||||
| ResidualPowder | < 2.0 mg/glove | Average 0.17 mg/gloveMeets ASTM D6124-06 | Average 0.19 mg/gloveMeets ASTM D6124-06 | |||||
| BiologicalEvaluation onMedical Device-Primary SkinIrritation Test | ISO 10993-10:2010 | Under the conditions ofthis study, the test articlewas a non-irritant. | Under the conditions ofthis study, the test articlewas a non-irritant. | |||||
| BiologicalEvaluation onMedicalDevice-DermalSensitizationAssay | ISO 10993-10:2010 | Under the conditions ofthis study, the test articlewas a non-sensitizer. | Under the conditions ofthis study, the test articlewas a non- sensitizer. | |||||
{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, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
{8}------------------------------------------------
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 +60-5-891 2777 FAX +60-5-891 2999
{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 +60-5-891 2777 FAX +60-5-891 2999
| 7) Methorexate(25mg/ml or25,000ppm),Minimum Breakthroughdetection time: > 240minutes | 9) Thiotepa (10mg/ml or10,000ppm),Breakthrough time: 67.8minutes. | |
|---|---|---|
| 8) Paclitaxel (6mg/ml or6,000ppm),Minimum Breakthroughdetection time:>240minutes | ||
| 9) Thiotepa (10mg/ml or10,000ppm),Minimum Breakthroughdetection time:56.9 minutes | ||
| 10) Ifosfamide(50mg/ml)Minimum Breakthroughdetection time: >240minutes | ||
| 11) Mitoxantrone(2mg/ml) ,Minimum Breakthroughdetection time: >240minutes | ||
| 12) Vincristine Sulfate(1mg/ml) ,Minimum Breakthroughdetection time: >240minutes | ||
| 13) Carboplatin(10.0mg/ml), MinimumBreakthrough detectiontime: >240 minutes | ||
| 14) Dacarbazine (DTIC)(10.0mg/ml) MinimumBreakthrough detectiontime: >240 minutes | ||
| 15) Mitomicin C(0.5mg/ml) MinimumBreakthrough detectiontime: >240 minutes |
{10}------------------------------------------------
(formerly known as Sinetimed Consumables Sdn. Bhd.)
Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
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 |
{11}------------------------------------------------
(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.
§ 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.