(135 days)
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.
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).
The provided text describes the acceptance criteria and performance of EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (K161187). This device is a patient examination glove and is assessed against the ASTM D6319-10 standard for Nitrile Examination Gloves and ASTM D6978-05 for permeation by chemotherapy drugs.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The core test for this device, beyond general glove properties, is its resistance to chemotherapy drugs. The acceptance criteria are implicit in the performance shown for the predicate device (K141982) and the subject device's indication to be "tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05 standards." The performance is reported as the "Minimum Breakthrough Detection Time (Min) in µg/cm²/minute." A longer breakthrough time indicates better resistance.
| Chemotherapy Drugs and Concentration | Acceptance Criteria (Implicit from ASTM D6978-05 compliance for gloves intended for chemotherapy drug use) | Reported Device Performance (EMG Blue Nitrile Examination Gloves K161187) |
|---|---|---|
| 1) Carmustine (BCNU) (3.3mg/ml) | Generally, ideally >240 minutes for many drugs, but lower for aggressive drugs is noted. For predicate, 15 µg/cm²/minute was acceptable. | 1.3 minutes |
| 2) Cyclophosphamide (20mg/ml) | > 240 minutes | > 240 minutes |
| 3) Cytarabine (100mg/ml) | > 240 minutes | > 240 minutes |
| 4) Doxorubicin Hydrochloride (2mg/ml) | > 240 minutes | > 240 minutes |
| 5) Etopside (20mg/ml) | > 240 minutes | > 240 minutes |
| 6) Fluorouracil (50mg/ml) | > 240 minutes | > 240 minutes |
| 7) Methotrexate (25mg/ml) | > 240 minutes | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes | > 240 minutes |
| 9) Thiotepa (10mg/ml) | Generally, ideally >240 minutes, but lower for aggressive drugs is noted. For predicate, 2 µg/cm²/minute was acceptable. | 67.8 minutes |
Note: The document explicitly states for the subject device: "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." This highlights that even with lower breakthrough times for these specific drugs, if tested according to the standard, the device is considered to meet the "tested for use with chemotherapy drugs" indication. The predicate device also showed similar, and in one case even lower (Thiotepa, 2 minutes), breakthrough times for these aggressive drugs.
Beyond chemotherapy drug resistance, the document also details other specifications that the gloves meet, primarily referencing ASTM D6319-10 (Standard specification for Nitrile Examination Gloves):
| Characteristic | Acceptance Criteria (from ASTM D6319-10) | Reported Device Performance (EMG Blue Nitrile Examination Gloves K161187) |
|---|---|---|
| Overall Length | Min 230 mm | Meets ASTM D6319-10 (Specific values for different sizes are S, M, L, XL all 230mm minimum) |
| Width | Size S = 85mm, M = 95mm, L = 105mm, XL = 115mm (± 5mm) | Meets ASTM D6319-10 (Specific values for different sizes are S=85, M=95, L=105, XL=115mm) |
| Thickness at Palm | Min 0.05 mm | Meets ASTM D6319-10 (Specific value is 0.05mm minimum) |
| Thickness at Finger Tip | Min 0.05 mm | Meets ASTM D6319-10 (Specific value is 0.05mm minimum) |
| Tensile Strength (Before Ageing) | 14 MPa min | Meets ASTM D6319-10 (Reported as "14min") |
| Ultimate Elongation (Before Ageing) | 500% min | Meets ASTM D6319-10 (Reported as "500min") |
| Tensile Strength (After Ageing) | 14 MPa min | Meets ASTM D6319-10 (Reported as "14min" after 70°C for 168 hrs @ 100°C for 22 hrs) |
| Ultimate Elongation (After Ageing) | 400% min | Meets ASTM D6319-10 (Reported as "400min" after 70°C for 168 hrs @ 100°C for 22 hrs) |
| Freedom from pinholes | AQL 2.5 (Inspection Level G-1) | Meets ASTM D5151-06 (This ASTM standard is referenced, not D6319-10 for pinholes, but given the "Meets" statement, it implies compliance with the stated AQL and inspection level, which are standard for examination gloves. The document states "AQL 2.5, Inspection Level G-1") |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 (This ASTM standard is referenced, not D6319-10 for residual powder. Given the "Meets" statement, it implies compliance with the stated limit.) |
| Primary Skin Irritation Test | Non-irritant status | Under the conditions of this study, the test article was a non-irritant. |
| Dermal Sensitization Assay | Non-sensitizer status | Under the conditions of this study, the test article was a non-sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the various tests (e.g., how many gloves were tested for chemotherapy permeation, physical properties, or biocompatibility). However, it consistently refers to compliance with established ASTM standards (D6319-10, D6978-05, D5151-06, D6124-06). These standards inherently define the sampling plans and testing methodologies.
- Data Provenance: The studies were performed by the manufacturer, Eco Medi Glove Sdn. Bhd., located in Malaysia. The type of study would be considered prospective testing in a laboratory setting to evaluate the device's performance against defined standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is a performance test for a physical medical device (gloves) against established engineering and material science standards (ASTM). It does not involve "ground truth" derived from expert medical opinion in the way an AI diagnostic algorithm would.
Instead, the "ground truth" (or more accurately, the pass/fail criteria) is established by the ASTM standards themselves, which are developed by experts in materials science, engineering, and medical device manufacturing. The testing would be performed by qualified laboratory technicians and engineers who are proficient in executing these standardized tests. The report does not specify the number or qualifications of these individuals directly, as their adherence to the standard methodologies is sufficient.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a direct performance test against quantitative standards, not an assessment requiring expert adjudication of a qualitative outcome. The outcomes are objective measurements (e.g., breakthrough time, tensile strength, elongation, presence of pinholes) or standardized biological evaluations (irritation, sensitization).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on their performance. This product is a physical medical device (examination gloves).
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Yes, in a sense, a standalone performance assessment was done. The glove's performance (e.g., resistance to chemotherapy drugs, physical properties, biocompatibility) was assessed independently of human interaction during its use. The "algorithm" here is the physical glove itself and its material properties, and its performance was measured directly.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these gloves is based on established standard specifications and test methods.
- For physical properties and general requirements for nitrile examination gloves, the ground truth is defined by ASTM D6319-10.
- For resistance to chemotherapy drug permeation, the ground truth and test methodology are defined by ASTM D6978-05.
- For pinholes, ASTM D5151-06.
- For residual powder, ASTM D6124-06.
- For biocompatibility, the tests (Primary Skin Irritation, Dermal Sensitization) follow recognized biological evaluation standards (often ISO 10993 series, though not explicitly stated for these specific tests, but generally implied for such evaluations).
These are all objective, quantitatively measurable criteria as defined by consensus standards, not subjective expert consensus, pathology, or outcomes data in the medical sense.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm or a diagnostic tool that requires a "training set" in the context of machine learning. The "training" in manufacturing comes from process control, material selection, and quality systems, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as in point 8.
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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
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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
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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)
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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 KuningKamunting Raya Industrial Estate34600,Kamunting PerakMalaysia. |
| 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 |
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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 +60-5-891 2777 FAX +60-5-891 2999
Appendix 2
| Measurement | Before Ageing | After Aging at 70℃ for168 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 NitrileExamination GlovesPowder Free withtested for use withchemotherapydrugs,K161187 | Dermagrip PowderFree Blue NitrilePatient ExaminationGloves, Non Sterile,Tested for use withchemotherapy Drugs,K141982 | AssessmentSimilarities andDifferences |
|---|---|---|---|---|
| Product Code | LZA and LZC | LZA and LZC | LZA and LZC | No differentbetween subjectand predicatedevices. |
| 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. | No differentbetween subjectand predicatedevices. |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound | No differentbetween subjectand predicatedevices. |
| Colour | Blue | Blue | Blue | No differentbetween subjectand predicatedevices. |
| Sterility | Non sterile | Non sterile | Non sterile | No differentbetween subjectand predicatedevices. |
| Single used | Single used | Single used | Single used | No differentbetween subjectand predicatedevices. |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile | No differentbetween subjectand predicatedevices. |
| 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 | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Subject devices andpredicate device isdifferent on thedimension. Subjectdevices is havingthickness at palmand finger of0.05mm (Min) andlength with 230mm(Min).Predicatedevices is withthickness at palmand finger of 0.07-0.10mm and lengthwith min 240mm |
| Physicalproperties | Before AgeingTensile Strength (MPa)= 14minUltimate Elongation(%)= 500minAfter Aging at 70°Cfor | Meets ASTM D6319-10 | Meets ASTM D6319-10 | No differentbetween subjectand predicatedevices. |
| 168 hrs @ 100°C for22 hrsTensile Strength (MPa)= 14minUltimate Elongation(%)= 400min | ||||
| Freedom frompinholes | AQL 2.5Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | No differentbetween subjectand predicatedevices. |
| ResidualPowder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 | No differentbetween subjectand predicatedevices. |
| BiologicalEvaluation onMedical Device-Primary SkinIrritation Test | Under the conditions ofthis study, the test articlewas a non-irritant. | Under the conditions ofthis study, the test articlewas a non-irritant. | No differentbetween subjectand predicatedevices. | |
| BiologicalEvaluation onMedicalDevice-DermalSensitizationAssay | Under the conditions ofthis study, the test articlewas a non-sensitizer. | Under the conditions ofthis study, the test articlewas a non- sensitizer. | No differentbetween subjectand predicatedevices. | |
| ResistanceagainstChemotherapyDrugs | Standards Practice forAssessment ofresistance of MedicalGlove to Permeation byChemotherapy drugsASTM D6978-05(2013) | 1) Carmustine (3.3mg/mlor 3000ppm),Minimum Breakthroughdetection time : 1.3μg/cm2/minute2) Cyclophosphamide(20mg/ml or20,000ppm),Minimum Breakthroughdetection time: >240μg/cm2/minute | 1) Carmustine (3.3mg/mlor 3000ppm),Minimum Breakthroughdetection time: 15μg/cm2/minute2) Cyclophosphamide(20mg/ml or20,000ppm),Minimum Breakthroughdetection time: >240μg/cm2/minute | Subject device wastested with 7mandatorychemotherapydrugs and withaddition 2chemotherapy.Predicate devicewas tested with 7mandatorychemotherapydrugs with |
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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. 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 or100,000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | 3) Dacarbazine(10mg/ml)Minimum Breakthroughdetection time:>240µg/cm²/minute | chemotherapydrugs. | |
|---|---|---|---|
| 4)DoxorubicinHydrochloride(2.0mg/ml or 2000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | 4)DoxorubicinHydrochloride (2.0mg/mlor 2000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | ||
| 5) Etoposide (20mg/mlor 20,000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | 5) Etoposide (20mg/mlor 20,000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | ||
| 6) Flourouracil(50mg/ml or 50,000),Minimum Breakthroughdetection time: >240µg/cm²/minute | 6) Flourouracil (50mg/mlor 50,000),Minimum Breakthroughdetection time: >240µg/cm²/minute | ||
| 7) Methotrexate(25mg/ml or25,000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | 7) Cisplatin (1 mg/ml)Minimum Breakthroughdetection time: >240µg/cm²/minute | ||
| 8) Paclitaxel (6mg/ml or6,000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | 8) Paclitaxel (6mg/ml or6,000ppm),Minimum Breakthroughdetection time: >240µg/cm²/minute | ||
| 9) Thiotepa (10mg/ml or10,000ppm),Minimum Breakthrough | 9) Thiotepa (10mg/ml or10,000ppm),Minimum Breakthrough | ||
| detection time: 67.8µg/cm²/minute | detection time: 2µg/cm²/minute | ||
| 10) Ifosfamide(50mg/ml)Minimum Breakthroughdetection time: >240µg/cm²/minute | |||
| 11) Mitoxantrone(2mg/ml),Minimum Breakthroughdetection time: >240µg/cm²/minute | |||
| 12) Vincristine Sulfate(1mg/ml),Minimum Breakthroughdetection time: >240µg/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 timein 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).
§ 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.