(84 days)
Not Found
No
The device is a physical examination glove and the summary does not mention any AI/ML components or functions.
No
The device is a glove intended to prevent contamination between patient and examiner, not to provide therapy.
No
This device is a glove, intended to prevent contamination and protect the examiner, not to diagnose a medical condition.
No
The device is described as physical gloves made of nitrile, intended to be worn on the hand. The description focuses on material properties, physical dimensions, and resistance to chemotherapy drugs, all of which are characteristics of a hardware device. There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Intended Use: The intended use of these gloves is to be worn on the examiner's hand to prevent contamination between the patient and the examiner. This is a barrier device used on the body (the examiner's hand) and in contact with the patient.
- Lack of Specimen Analysis: The description does not mention any analysis of human specimens. The testing described is related to the physical properties of the glove material and its resistance to chemotherapy drugs, not the diagnosis or monitoring of a patient's condition through specimen analysis.
Therefore, based on the provided information, these gloves are a medical device, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results."
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA
Device Description
"Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large.
Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
The proposed and predicate devices are made of nitrile synthetic latex."
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)
Non-Clinical Performance Data: The device was tested for biocompatibility, physical properties (tensile strength, ultimate elongation before and after aging), freedom from holes (ASTM D5151-06, ASTM D6319 AQL 2.5/Inspection Level G-I), powder content, and chemotherapy drug permeation (ASTM D6978-05).
Key results include:
- Biocompatibility: Not a sensitizer or irritant.
- Physical Properties (before aging): Tensile Strength 15 Mpa min, Ultimate Elongation 500% min.
- Physical Properties (after aging): Tensile Strength 14 Mpa min, Ultimate Elongation 400% min.
- Powder Content: Max. 0.52 mg per glove.
- Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time):
- Carmustine (3.3 mg/ml): 12.4 minutes
- Thiotepa (10.0 mg/ml): 24.4 minutes
- Cisplatin (1.0 mg/ml): No breakthrough for up to 240 minutes
- Cyclophosphamide (20 mg/ml): No breakthrough for up to 240 minutes
- Doxorubicin HCl (2.0 mg/ml): No breakthrough for up to 240 minutes
- Etoposide (20.0 mg/ml): No breakthrough for up to 240 minutes
- Fluorouracil (50.0 mg/ml): No breakthrough for up to 240 minutes
- Mitoxantrone (2.0 mg/ml): No breakthrough for up to 240 minutes
- Paclitaxel (6.0 mg/ml): No breakthrough for up to 240 minutes
- Dacarbazine (10.0 mg/ml): No breakthrough for up to 240 minutes
- Ifosfamide (50.0 mg/ml): No breakthrough for up to 240 minutes
- Vincristine Sulfate (1.0 mg/ml): No breakthrough for up to 240 minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
November 13, 2017
Central Medicare Sdn. Bhd. Arivalagan Subramaniam QA/RA Manager PT 2609 - 2620, BT 8, Jalan Changkat Jong Teluk Intan, 36000 MALAYSIA
Re: K172525
Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: August 15, 2017 Received: August 21, 2017
Dear Arivalagan Subramaniam:
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 Part 807); labeling (21 CFR Part 801); medical device 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. 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
Indications for Use
510(k) Number (if known)
Device Name
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| * Carmustine (3.3 mg/ml) | Min minutes before breakthrough = 12.4 |
| Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Cyclophosphamide (20 mg/ml) | No breakthrough for up to 240 minutes |
| Doxorubicin HCl (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| Etoposide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| Fluorouracil (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| Mitoxantrone (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| Paclitaxel (6.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Thiotepa (10.0 mg/ml) | Min minutes before breakthrough = 24.4 |
| Dacarbazine (10.0 mg/ml) | No breakthrough for up to 240 minutes |
| Ifosfamide (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| Vincristine Sulfate (1.0 mg/ml) | No breakthrough for up to 240 minutes |
- Please note that the following drugs have extremely low permeation times:
Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 TelukIntan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
510(k) Summary
510(k) Number: K172525
Date Prepared: 13th October 2017
1.0 Submitter:
| Name: | Arivalagan Subramaniam
QA/RA Manager |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | Central Medicare Sdn. Bhd.
PT 2609-2620, Batu 8,
Jalan Changkat Jong, 36000 Teluk Intan,
Perak, Malaysia |
| Contact: | Tel: +605-629 0000 Fax: +605-629 0001 |
| 510(k) Submission Prepared by: | Muhammad Abdul Rahman
Regulatory Affairs Officer
Central Medicare Sdn. Bhd. |
2.0 Name of the device:
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
| Common Names: | Chemotherapy Gloves, Exam Gloves |
|---|---|
| Device Class: | Class I |
| Classification Names: | Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC, LZA) |
3.0 Identification of the Legally Marketed Devices that equivalency is claimed:
| Trade Name: | Blue Non Sterile Powder Free Nitrile |
|---|---|
| Examination Gloves Tested for Use with | |
| Chemotherapy Drugs |
510k Number: K172525
4.0 Description of the Device:
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large.
4
PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 TelukIntan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
510(k) Summary
Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
5.0 Intended Use of the Device:
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| *Carmustine (3.3 mg/ml) | Min minutes before breakthrough = 12.4 |
| Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Cyclophosphamide (20 mg/ml) | No breakthrough for up to 240 minutes |
| Doxorubicin HCl (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| Etoposide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| Fluorouracil (50.0 mh/ml) | No breakthrough for up to 240 minutes |
| Mitoxantrone (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| Paclitaxel (6.0 mg/ml) | No breakthrough for up to 240 minutes |
| *Thiotepa (10.0 mg/ml) | Min minutes before breakthrough = 24.4 |
| Dacarbazine (10.0 mg/ml) | No breakthrough for up to 240 minutes |
| Ifosfamide (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| Vincristine Sulfate (1.0 mg/ml) | No breakthrough for up to 240 minutes |
- Please note that the following drugs have extremely low permeation times: Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes
6.0 Summarv of the Technological Characteristics of the Device:
The proposed and predicate devices all share the same technological characteristics and design by meeting ASTM D6319-10 and following the FDA's Medical Glove Guidance Manual.
The purpose of this submission is to demonstrate that the proposed device is substantially equivalent, to a legally marketed predicate device, a specialty chemotherapy glove, Hebei Hongsen Plastics Technology Co, Ltd's POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (K163146). The proposed device will be known as Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.
5
PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 TelukIntan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
510(k) Summary
Biocompatibility studies were performed on the proposed device. Under the conditions of the study, the proposed device is not a sensitizer, or an irritant.
The proposed and predicate devices are made of nitrile synthetic latex. The proposed device have similar technological characteristics compared to the predicate devices, as both devices meet ASTM D6319-10 and follow FDA's Medical Glove Guidance Manual.
The technological characteristics and design for the proposed device have been assessed and confirmed that the standard specifications and performance are appropriate for the requirements of powder free nitrile examination gloves and specialty chemotherapy gloves.
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs of the proposed and predicate devices.
| Proposed Device | Predicate Device | Remark | |
|---|---|---|---|
| Sponsor | Central Medicare Sdn. Bhd. | ||
| (as both the sponsor and manufacturer) | Hebei Hongsen Plastics | ||
| Technology Co, Ltd | |||
| Trade Name | Blue Non Sterile Powder Free Nitrile Examination | ||
| Gloves Tested for Use with Chemotherapy Drugs | POWDER FREE Blue Nitrile GLOVES, | ||
| Tested for Use with Chemotherapy Drugs | Similar | ||
| 510k Number | K172525 | K163146 | |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | Same | |
| Indications for Use | Blue Non Sterile Powder Free Nitrile Examination | ||
| Gloves Tested for Use with Chemotherapy Drugs | |||
| is a disposable device intended for medical | |||
| purposes that is worn on the examiner's hands to | |||
| prevent contamination between patient and | |||
| examiner. | The POWDER FREE Blue Nitrile | ||
| GLOVES, Tested for Use with | |||
| ChemotherapyDrugs is a disposable | |||
| device intended for medical purposes that | |||
| is worn on the examiner's hands to | |||
| prevent contamination between patient and | |||
| examiner. | Same | ||
| Powder or Powder | |||
| Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | Blue | Similar |
| Labeling | |||
| Information | Single-use indication, powder free, device name, | ||
| glove size, quantity, Nitrile Examination Gloves, | |||
| Non Sterile | Single-use indication, powder free, device | ||
| name, glove size, quantity, Nitrile | |||
| Examination Gloves, Non Sterile | Same | ||
| ChemotherapyDrug | |||
| Permeation Claim | Fluorouracil, Etoposide (Toposar), | ||
| Cyclophosphamid (Cytoxan), Carmustine (BCNU), | |||
| Thiotepa, Paclitaxel (Taxol), Doxorubicin | |||
| Hydrochloride, Dacarbazine (DTIC), Cisplatin, | |||
| lfosfamide, Mitoxantrone, Vincristine Sulfate | Fluorouracil, Etoposide (Toposar), | ||
| Cyclophosphamid (Cytoxan), Carmustine | |||
| (BCNU), Thiotepa, Paclitaxel (Taxol), | |||
| Doxorubicin Hydrochloride, Dacarbazine | |||
| (DTIC), Cisplatin, Carboplatin, Docetaxel, | |||
| lfosfamide, Irinotecan, Mechlorethamine | |||
| HCL, Methotrexate, Mitomycin C, | |||
| Mitoxantrone, Vincristine Sulfate | Similar |
General Comparison Table:
6
PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
510(k) Summary
De vice Dimensions Table:
| Proposed Device | |||||||
|---|---|---|---|---|---|---|---|
| Size | Tolerance | ||||||
| XS | S | M | L | XL | |||
| Blue Non Sterile Powder | |||||||
| Free Nitrile Examination | |||||||
| Gloves Tested for Use | |||||||
| with Chemotherapy Drugs | Length | minimum 230 | |||||
| Width (mm) | 70 | 80 | 95 | 110 | 120 | $\pm0.10$ | |
| Thickness (mm) | |||||||
| Cuff | 0.06 | $\pm0.03$ | |||||
| Palm | 0.08 | $\pm0.03$ | |||||
| Finger | 0.10 | $\pm0.03$ | |||||
| Predicate Device | |||||||
| Size | Tolerance | ||||||
| XS | S | M | L | XL | |||
| POWDER FREE Blue | |||||||
| Nitrile GLOVES, Tested | |||||||
| for Use with | |||||||
| Chemotherapy Drugs | |||||||
| (163146) | Length | minimum 230 | |||||
| Width (mm) | 70 | 80 | 95 | 110 | 120 | $\pm0.10$ | |
| Thickness (mm) | |||||||
| Cuff | 0.06 | $\pm0.03$ | |||||
| Palm | 0.08 | $\pm0.03$ | |||||
| Finger | 0.10 | $\pm0.03$ |
Performance Comparison Table:
| Proposed Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Item | Blue Non Sterile Powder | ||||
| Free Nitrile Examination | |||||
| Gloves Tested for Use with | |||||
| Chemotherapy Drugs | POWDER FREE Blue Nitrile | ||||
| GLOVES, Tested for Use | |||||
| with Chemotherapy Drugs | Remark | ||||
| Color | Blue | Blue | Similar | ||
| Physical | |||||
| Properties | Before | Tensile Strength | 15 Mpa min | 15 Mpa min | Same |
| Aging | Ultimate Elongation | 500% min | 500% min | Same | |
| After | |||||
| Aging | Tensile Strength | 14 Mpa min | 14 Mpa min | Same | |
| Ultimate Elongation | 400% min | 400% min | Same | ||
| Freedom from Holes | In accordance with ASTM | ||||
| D5151-06, following ASTM | |||||
| D6319 AQL 2.5/Inspection | |||||
| Level G-I | Be free from holes when | ||||
| tested in accordance with | |||||
| ASTM D5151 AQL 1.5 | Similar | ||||
| Powder Content | Max. 0.52 mg per glove | Max. 0.32 mg per glove | Similar |
7
PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 Teluk Intan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
510(k) Summary
Che motherapy Permeation Comparison Claim:
| Chemotherapy Drug Testing - ASTM D6978-05 | |||||
|---|---|---|---|---|---|
| Proposed Device | Predicate Device | ||||
| Tested Chemotherapy | |||||
| Drug and | |||||
| Concentration | MinimumBreakthrough | ||||
| Detection Time | |||||
| (minutes) | Tested Chemotherapy | ||||
| Drug and | |||||
| Concentration | Average Breakthrough | ||||
| Detection Time | |||||
| (minutes) | Remark | ||||
| Fluorouracil (50.0 mh/ml) | No breakthrough for up to | ||||
| 240 minutes | Fluorouracil (50.0 mh/ml) | No breakthrough for up to | |||
| 240 minutes | Same | ||||
| Etoposide (20.0 mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Etoposide (20.0 mg/ml) | No breakthrough for up to | |||
| 240 minutes | Same | ||||
| Cyclophosphamide (20 | |||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Cyclophosphamide (20 | ||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Same | ||||
| Carmustine (3.3 mg/ml) | Mn minutes before | ||||
| breakthrough = 12.4 | Carmustine (3.3 mg/ml) | Mn minutes before | |||
| breakthrough = 45.0 | Similar | ||||
| Thiotepa (10.0 mg/ml) | Mn minutes before | ||||
| breakthrough = 24.4 | Thiotepa (10.0 mg/ml) | Mn minutes before | |||
| breakthrough = 30.0 | Similar | ||||
| Paclitaxel (6.0 mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Paclitaxel (6.0 mg/ml) | No breakthrough for up to | |||
| 240 minutes | Same | ||||
| Doxorubicin HCl (2.0 | |||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Doxorubicin HCl (2.0 | ||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Same | ||||
| Dacarbazine (10.0 | |||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Dacarbazine (10.0 | ||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Same | ||||
| Cisplatin (1.0 mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Cisplatin (1.0 mg/ml) | No breakthrough for up to | |||
| 240 minutes | Same | ||||
| Carboplatin (10.0 mg/ml) | Not Tested | Carboplatin (10.0 mg/ml) | No breakthrough for up to | ||
| 240 minutes | Will not be | ||||
| claimed | |||||
| Docetaxel (10.0 mg/ml) | Not Tested | Docetaxel (10.0 mg/ml) | No breakthrough for up to | ||
| 240 minutes | Will not be | ||||
| claimed | |||||
| lfosfamide (50.0 mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Ifosfamide (50.0 mg/ml) | No breakthrough for up to | |||
| 240 minutes | Same | ||||
| Irinotecan (20.0 mg/ml) | Not Tested | Irinotecan (20.0 mg/ml) | No breakthrough for up to | ||
| 240 minutes | Will not be | ||||
| claimed | |||||
| Mechlorethamine HCL | |||||
| (1.0 mg/ml) | Not Tested | Mechlorethamine HCL | |||
| (1.0 mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Will not be | ||||
| claimed | |||||
| Methotrexate (25.0 | |||||
| mg/ml) | Not Tested | Methotrexate (25.0 | |||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Will not be | ||||
| claimed | |||||
| Mitomycin C (0.5 mg/ml) | Not Tested | Mitomycin C (0.5 mg/ml) | No breakthrough for up to | ||
| 240 minutes | Will not be | ||||
| claimed | |||||
| Mitoxantrone (2.0 mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Mitoxantrone (2.0 mg/ml) | No breakthrough for up to | |||
| 240 minutes | Same | ||||
| Vincristine Sulfate (1.0 | |||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Vincristine Sulfate (1.0 | ||||
| mg/ml) | No breakthrough for up to | ||||
| 240 minutes | Same |
8
PT 2609 – 2620, Jalan Changkat Jong, Mukim Changkat Jong, 36000 TelukIntan, Perak. Tel: +605 629 0000 Fax: +605 629 0001
510(k) Summary
7.0 Non-Clinical Performance Data
The proposed device and its predicate devices share intended use, are made of the same material, are within the same minimum specifications of thickness and length by meeting ASTM D6319-10, similar permeation rates for chemotherapy drugs as per ASTM D6978-05, similar labeling, physical properties, freedom from powder, biocompatibility and water tightness.
The above test results demonstrated that the proposed device complies with the following standards: ASTM D6319.10
8.0 Clinical Performance Data
NA
9.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the proposed device is substantially equivalent to the predicate device POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (K163146).