(112 days)
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, powder free, with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
This document describes the validation of the "EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs" (K141623) by establishing its substantial equivalence to a legally marketed predicate device (K110921). The "device" in this context refers to these medical examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparative table between the subject device (K141623) and the predicate device (K110921), outlining acceptance criteria for various characteristics and how both devices perform against them.
| Characteristics | Acceptance Criteria | EMG Blue Nitrile Medical Examination Gloves Powder Free with tested for use with chemotherapy drugs (K141623) (Reported Performance) | Nitrile Cornflower Blue Powder Free gloves tested for use with Chemotherapy drugs (Non-Sterile ), K110921 (Predicate Performance) |
|---|---|---|---|
| Product Code | LZC | LZC | LZC |
| 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. Also, tested for use with chemotherapy drugs. | Meets the description: 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. | Meets the description: 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. |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound |
| Colour | Blue | Blue | Blue |
| Sterility | Non sterile | Non sterile | Non sterile |
| Single used | Single used | Single used | Single used |
| Dimensions | Overall Length (mm) Min 270mmWidth (± 5mm) Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm) Min; 0.10mmThickness at Finger Tip (mm) Min 0.10 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical properties | Before Ageing: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 500minAfter Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from pinholes | AQL 2.5 Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biological Evaluation on Medical Device - Primary Skin Irritation Test | 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. |
| Biological Evaluation on Medical Device - Dermal Sensitization Assay | 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. |
| Resistance against Chemotherapy Drugs (ASTM D6978-05 Standards for Breakthrough Time) | Carmustine (BCNU) (3.3mg/ml): Min Breakthrough detection time in Minutes, 0.01µg/cm²/minute: Not explicitly stated as acceptance criteria, but listed as observed performance. | 1) Carmustine (3.3mg/ml): 1.3 minutes2) Cyclophosphamide (20mg/ml): > 240 minutes3) Cytarabine (100mg/ml): > 240 minutes4) Doxorubicin Hydrochloride (2 mg/ml): > 240 minutes5) Etoposide (20mg/ml): > 240 minutes6) Fluorouracil (50mg/ml): > 240 minutes7) Methorexate (25mg/ml): > 240 minutes8) Paclitaxel (6mg/ml): > 240 minutes9) Thiotepa (10mg/ml): 67.8 minutes | 1) Carmustine (3.3mg/ml): 4.5min.2) Cyclophosphamide (20mg/ml): >240 min.3) Cytarabine (100mg/ml): >240 min.4)Doxorubicin Hydrochloride (2.0mg/ml): >240 min.5) Etoposide (20mg/ml): >240 min.6) Flourouracil (50mg/ml): >240 min.7) Methorexate (25mg/ml): > 240 min.8) Paclitaxel (6mg/ml): >240 min.9) Thiotepa (10mg/ml): 6.88 min. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence demonstration based on performance testing and comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual glove samples were used for chemotherapy permeation per drug). However, the general acceptance criteria for "Freedom from pinholes" adheres to AQL 2.5, Inspection Level G-1, which implies a sampling plan defined by ASTM D5151-06. The dimensions, physical properties, and residual powder also refer to ASTM standards (D6319-10 and D6124-06) which include sampling plans. For the chemotherapy drug permeation, it states "Minimum Breakthrough detection time" for each drug, which is typically derived from a set of tests.
- Data Provenance: The manufacturing company is ECO MEDI GLOVE SDN. BHD. from Malaysia. Therefore, the testing and data provenance is likely from Malaysia or conducted by a laboratory collaborating with the Malaysian manufacturer. The document doesn't specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be collected specifically for the purpose of demonstrating equivalence, making it effectively prospective for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This type of device (medical examination gloves) does not typically involve human experts establishing "ground truth" in the way a diagnostic AI device would. The "ground truth" here is objective measurement against established industry standards and regulatory requirements.
- For standards like ASTM D6319-10 (physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy permeation), the "ground truth" is defined by the methodology and specifications within the standard itself, executed by trained laboratory personnel.
- For biological evaluations (skin irritation, dermal sensitization), "ground truth" is established through standardized biological testing protocols and interpreted by qualified toxicologists or biologists, although the specific number and qualifications are not detailed here.
4. Adjudication Method for the Test Set:
Not applicable in the conventional sense for this type of device. The determination of whether a glove "meets" a standard (e.g., AQL 2.5 for pinholes) is based on the objective outcome of the standardized test and the defined acceptance limits, not human expert adjudication of a diagnostic result.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI diagnostic device where human reader performance (with or without AI assistance) would be a relevant metric. The device is a physical product (gloves) whose performance is measured against physical and chemical standards.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This is not an algorithm or software device. The "performance" described is that of the physical glove itself.
7. Type of Ground Truth Used:
The ground truth used is primarily based on established industry standards and physical/chemical measurements:
- Physical Specifications: Dimensions, tensile strength, ultimate elongation, freedom from pinholes (AQL 2.5, Inspection Level G-1), residual powder. These are objective measurements compared against criteria set in ASTM standards (D6319-10, D5151-06, D6124-06).
- Biocompatibility: Primary Skin Irritation Test and Dermal Sensitization Assay results (non-irritant, non-sensitizer). These are derived from biological testing protocols following standard toxicology guidelines.
- Chemical Resistance: Minimum Breakthrough Detection Time for various chemotherapy drugs, measured according to ASTM D6978-05. This involves laboratory testing where the time it takes for a chemical to permeate the glove material is objectively measured.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7,2014
Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23836, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Kamunting Perak, Malaysia 34600
Re: K141623
Trade/Device Name: EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs Labeling Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 5, 2014 Received: September 5, 2014
Dear Mr. Suresh Kumar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141623
Device Name
EMG Blue Nitrile Examination Gloves Powder Free with Chemotherapy Drues
Indications for Use (Describe)
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs
| Chemotherapy Drug and concentration | Minimum Breakthrough detection time in Minutes, 0.01µg/cm²/minute |
|---|---|
| 1)Carmustine (BCNU) (3.3mg/ml) | 1.3 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (100mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 67.8 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time : Carmustine (BCNU) (3.3mg/ml)
Thiotepa (10mg/ml)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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formerly known as Sinetimed Consumables Sdn. Bhd.
23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. +60-5-891 2777 FAX +60-5-891 2999
Appendix 2 (510k#: K141623)
510(K) Summary EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
1.0 Submitter :
| Company Name | : ECO MEDI GLOVE SDN. BHD. |
|---|---|
| Company Address | : Lot 23826,Jalan Tembaga KuningKamunting Raya Industrial Estate34600,Kamunting PerakMalaysia. |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
- : suresh@ecomediglove.com.my
- 2.0 Preparation Date : 23rd September 2014
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}------------------------------------------------
nerly known as Sinetimed Consumables Sdn. Bhd.
t 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777
Appendix 2 (510k#: K141623)
4.0) Identification of The Legally Marketed Device :
Class I patient Examination glove with tested for use with Chemotherapy Drugs, Powder Free,LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K110921, Cornflower Powder Free Exam glove tested for use with Chemotherapy Drugs (Non sterile) .
Device Description 5.0
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, powder free, with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Blue Nitrile Medical Examination Gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
6.0 Specification for Nitrile gloves: 6.1 Dimension and Thickness of Gloves
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) | 270min | 270min | 270min | 270min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
| Thickness at Finger Tip (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
{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 (510k#: K141623)
6.1.2 Gloves Physical Properties and Holes
| 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 2.5Inspection Level G-1 | AQL 2.5Inspection Level G-1 |
Gloves meet all the specification listed in ASTM D 6319-10
| Characteristics | Acceptance Criteria | EMG Blue NitrileMedical ExaminationGloves Powder Freewith tested for use withchemotherapy drugs(K141623) | Nitrile Cornflower BluePowder Free gloves testedfor use withChemotherapy drugs(Non-Sterile ), K110921 |
|---|---|---|---|
| Product Code | LZC | LZC | LZC |
| Intended use | A powder free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner. The device isfor over-the-counteruse. | 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 device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use. |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound |
| Colour | Blue | Blue | Blue |
| Sterility | Non sterile | Non sterile | Non sterile |
| Single used | Single used | Single used | Single used |
| Non Sterile | Non Sterile | Non Sterile | Non SterileSection 2A-3 |
| Appendix 2(510k#: K141623) | |||
| Dimensions | Overall Length (mm)Min 270mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)Min; 0.10mmThickness at Finger Tip (mm)Min 0.10 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical properties | Before AgeingTensile Strength (MPa)= 14minUltimate Elongation (%)= 500minAfter Aging at 70°C for168 hrs @ 100°C for 22 hrsTensile Strength (MPa)= 14minUltimate Elongation (%)= 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from pinholes | AQL 2.5Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biological Evaluation onMedical Device --Primary Skin IrritationTest | Under the conditions ofthis study, the test articlewas a non-irritant. | Under the conditions ofthis study, the test articlewas a non-irritant. | |
| Biological Evaluation onMedical Device -Dermal SensitizationAssay | Under the conditions ofthis study, the test articlewas a non-sensitizer. | Under the conditions ofthis study, the test articlewas a non-sensitizer. | |
| Resistance againstChemotherapy Drugs | 1) Carmustine (3.3mg/mlor 3000ppm),Breakthrough : 1.3 min. | 1) Carmustine (3.3mg/mlor 3000ppm),Breakthrough : 4.5min.Section 2A-4 | |
| Appendix 2(510k#: K141623) | |||
| Standards Practice forAssessment of resistance ofMedical Glove to Permeationby Chemotherapy drugsASTM D6978-05(2013) | 2) Cyclophosphamide(20mg/ml or20,000ppm),Breakthrough time :>240 min. | 2) Cyclophosphamide(20mg/ml or 20,000ppm),Breakthrough time : >240min.3) Cytarabine (100mg/mlor 100,000ppm),Breakthrough time : >240min. | |
| 3) Cytarabine (100mg/mlor 100,000ppm),Breakthrough time :>240 min. | 4)DoxorubicinHydrochloride (2.0mg/mlor 2000ppm),Breakthrough time : >240min. | ||
| 4)DoxorubicinHydrochloride (2.0mg/mlor 2000ppm),Breakthrough time :>240 min. | 5) Etoposide (20mg/ml or20,000ppm), Breakthroughtime : >240 min. | ||
| 5) Etoposide (20mg/mlor 20,000ppm),Breakthrough time :>240 min. | 6) Flourouracil (50mg/mlor 50,000), Breakthroughtime : >240 min. | ||
| 6) Flourouracil (50mg/mlor 50,000), Breakthroughtime : >240 min. | 7) Methorexate (25mg/mlor 25,000ppm),Breakthrough time : > 240min. | ||
| 7) Methorexate (25mg/mlor 25,000ppm),Breakthrough time : >240 min. | 8) Paclitaxel (6mg/ml or6,000ppm), Breakthroughtime : >240 min. | ||
| 8) Paclitaxel (6mg/ml or6,000ppm),Breakthrough time :>240 min. | 9) Thiotepa (10mg/ml or10,000ppm), Breakthroughtime : 6.88 min. | ||
| 9) Thiotepa (10mg/ml or10,000ppm),Breakthrough time : 67.8min. |
{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. TEL +60-5-891 2777 FAX +60-5-891 2999
{8}------------------------------------------------
(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
{9}------------------------------------------------
(formerly known as Sinetimed Consumables Sdn. Bhd.)
23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. +60-5-891 2777
Appendix 2 (510k#: K141623)
7.0 Intended use of the Device
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and for use with chemotherapy drugs . It is for overthe-counter use.
In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
| Chemotherapy Drug and concentration | Minimum Breakthrough detection timein Minutes,0.01µg/cm²/minute |
|---|---|
| 1)Carmustine (BCNU) (3.3mg/ml) | 1.3 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (100mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 67.8 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.
Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)
{10}------------------------------------------------
(formerly known as Sinetimed Consumables Sdn. Bhd.)
23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. I +60-5-891 2777
Appendix 2 (510k#: K141623)
8.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion
There are no differences in technological characteristics of the subject device compare with the predicate device.
The gloves are made from nitrile latex compound, Blue colour, Powder free and nonsterile. The gloves met all the specifications in ASTM D6319-10 Standard specification for Nitrile Examination Gloves as well Biological Evaluation on medical device. Additionally, the gloves have been tested for permeability to chemotherapy drugs.
Based on the intended uses, physical properties and technological characteristics, the subject device is as safe and effective as a legally marketed device- K110921, Nitrile Cornflower Blue Powder Free Exam Gloves Medical Exam tested for use with Chemotherapy Drugs test, and its does not raise different questions of safety and effectiveness.
9.0 Conclusion
Based on intended uses, technological characteristics and non - clinical performance data, the EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs (K141623) is substantially equivalent to the predicate device (K110921).
§ 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.