(134 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No
The device is a medical glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is a barrier and protective one, not to provide diagnostic information about a patient's health status.
No
The device is a physical examination glove, which is a hardware medical device, not software. The description focuses on physical properties and testing of the glove material.
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 the body.
- Device Function: The described device is a patient examination glove. Its function is to act as a physical barrier on the examiner's hand to prevent contamination between the patient and the examiner. It does not analyze any biological specimens.
- Intended Use: The intended use is for medical purposes, specifically for examination and preventing contamination. This is a physical barrier function, not a diagnostic one.
- Testing: While the gloves are tested for resistance to chemotherapy drugs, this testing is related to the glove's barrier properties and safety for the user when handling these substances. It is not a diagnostic test performed on a patient sample.
The description clearly indicates a physical barrier device used during patient examination, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 15.0 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 30.1minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 2.4 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 1.9 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 2.4 minutes ThioTEPA (10.0 mg/ml): 1.9 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA
Device Description
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examiner's hand or finger
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-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue have the below technological characteristic compared to ASTM or Equivalent standards.
-
This glove is compliant with the ASTM standards and similar to the predicate device in the market, which has a glove thickness less than 0.10mm and length less than 270mm. The chemotherapy claim is similar to Predicate.
-
Device Performance for Blue and Cobalt Blue gloves:
- Dimension: Min 240mm (ASTM D6319-10)
- Physical Properties: Meets (ASTM D6319-10)
- Thickness:
- Finger: 0.03mm min (ASTM D6319-10)
- Palm: 0.05mm min (ASTM D6319-10)
- Cuff: 0.05mm min (ASTM D6319-10)
- Powder-free: Meets (ASTM D6124-06 ( 240
- Carmustine, 3.3mg/ml: 15.0
- Cisplatin, 1.0mg/ml: > 240
- Cyclophosphamide (Cytoxan), 20.0mg/ml: > 240
- Dacarbazine (DTIC), 10.0mg/ml: > 240
- Doxorubicin Hydrochloride, 2.0mg/ml: > 240
- Etoposide (Toposar), 20.0mg/ml: > 240
- Fluorouracil, 50.0mg/ml: > 240
- Ifosfamide, 50.0mg/ml: > 240
- Methotrexate, 25mg/ml: > 240
- Mitomycin C, 0.5mg/ml: > 240
- Mitoxantrone, 2 mg/ml: > 240
- Paclitaxel (Taxol), 6.0mg/ml: > 240
- Thiotepa, 10.0mg/ml: 30.1
- Vincristine Sulfate, 1.0mg/ml: > 240
- Warning for Blue: Carmustine: 15.0 minutes and ThioTepa: 30.1 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTΕΡΑ.
- Cobalt Blue:
- Carboplatin, 10mg/ml: > 240
- Carmustine, 3.3mg/ml: 2.4
- Cisplatin, 1.0mg/ml: > 240
- Cyclophosphamide (Cytoxan), 20.0mg/ml: > 240
- Dacarbazine (DTIC), 10.0mg/ml: > 240
- Doxorubicin Hydrochloride, 2.0mg/ml: > 240
- Etoposide (Toposar), 20.0mg/ml: > 240
- Fluorouracil, 50.0mg/ml: > 240
- Ifosfamide, 50.0mg/ml: > 240
- Methotrexate, 25mg/ml: > 240
- Mitomycin C, 0.5mg/ml: > 240
- Mitoxantrone, 2 mg/ml: > 240
- Paclitaxel (Taxol), 6.0mg/ml: > 240
- Thiotepa, 10.0mg/ml: 1.9
- Vincristine Sulfate, 1.0mg/ml: > 240
- Warning for Cobalt Blue: Carmustine: 1.82 minutes and ThioTepa: 0.93 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.
-
Other Characteristics:
- Water tightness (1000ml): Passes
- Material: Nitrile
- Size: Extra Small, Small, Medium, Large, Extra Large
- Texture: Finger Textured
- Single Use: Single Use
- Expiration claim: 5 years
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Yty Industry (manjung) Sdn Bhd Punitha Samy Deputy Manager-DC/RA Lot 1422-1424, Batu 10 Lekir Sitiawan, 32020 My
Re: K171104
Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue) and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: July 19, 2017 Received: August 3, 2017
Dear Punitha Samy:
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.
Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.
1
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 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 (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. 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,
Tara A. Ryan -S
for Lori 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
510(k) Number (if known)
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 15.0 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 30.1minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ---------------------------------------------- |
区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171104
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 2.4 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 1.9 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 2.4 minutes ThioTEPA (10.0 mg/ml): 1.9 minutes
Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
K171104
510 (K) SUMMARY
| 1.0 | 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD., |
| Lot 1422-1424, Batu 10 Lekir | ||
| 32020 Sitiawan, Perak | ||
| Malaysia | ||
| Tel | 605-6908533 | |
| Fax | 605-6908533 | |
| Name of Contact Person | Punitha Samy (Ms) | |
| E-mail: punitha.samy@ytygroup.com.my | ||
| Date Summary Prepared | August 24, 2017 | |
| 3.0 | Name of Device | |
| Trade Name: | Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use | |
| With Chemotherapy Drugs - Blue | ||
| Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use | ||
| With Chemotherapy Drugs - Cobalt Blue | ||
| Common Name: | Nitrile Examination Gloves | |
| Classification Name: | Patient Examination Gloves, Powder Free | |
| Device Classification: | I | |
| Regulation No. & Classification Name: Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC) | ||
| Patient Examination Gloves (21 CFR 880.6250 product code LZA) | ||
| Panel: | General Hospital |
4.0 Identification of The Legally Marketed Devices that equivalency is claimed:
| Device Name | Brightway Brand Nitrile Examination
Gloves, Powder Free, [Sterling/Grey] Tested For
Use With
Chemotherapy Drugs |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Predicate 510(K)
number: | K161215 |
| Device Classification: | I |
| Product Code: | LZC |
5
5.0 Description of The Device
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Characteristic | Concentration | Blue
Average Breakthrough Detection Time (minutes) | Cobalt Blue
Average Breakthrough Detection Time (minutes) |
|-------------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Carboplatin | 10mg/ml | > 240 | > 240 |
| *Carmustine | 3.3mg/ml | 15.0 | 2.4 |
| Cisplatin (BCNU) | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| Doxorubicin
Hydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 | > 240 |
| Methotrexate | 25mg/ml | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 30.1 | 1.9 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | | *WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 15.0 minutes and ThioTepa: 30.1 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA | * WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 2.4 minutes and ThioTepa: 1.9 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA |
6
7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs – Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue have the below technological characteristic compared to ASTM or Equivalent standards.
This glove is compliant with the ASTM standards and similar to the predicate device in the market, which has a glove thickness less than 0.10mm and length less than 270mm. The chemotherapy claim is similar to Predicate.
| Characteristic | Standards | Device Performance | |||
|---|---|---|---|---|---|
| Predicate | Blue | Cobalt Blue | |||
| 510(K) Number | K161215 | K171104 | K171104 | ||
| Dimension | ASTM D6319-10 | Min 240mm | Min 240mm | Min 240mm | |
| Physical Properties | ASTM D6319-10 | Meets | Meets | Meets | |
| Thickness | Finger | ASTM D6319-10 | 0.03 – 0.05mm | 0.03mm min | 0.03mm min |
| Palm | 1.5 – 0.08mm | 0.05mm min | 0.05mm min | ||
| Cuff | 1.6 – 0.09mm | 0.05mm min | 0.05mm min | ||
| Powder-free | ASTM D6124-06 | ||||
| ( 240 | > 240 | ||||
| *Carmustine | 3.3mg/ml | 10.1 | 15.0 | 2.4 | |
| Cisplatin | 1.0mg/ml | > 240 | > 240 | > 240 | |
| Cyclophosphamide | |||||
| (Cytoxan) | 20.0mg/ml | > 240 | > 240 | > 240 | |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 | > 240 | |
| Doxorubicin | |||||
| Hydrochloride | 2.0mg/ml | > 240 | > 240 | > 240 | |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 | > 240 | |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 | > 240 | |
| Ifosfamide (Ifex) | 50.0mg/ml | > 240 | > 240 | > 240 | |
| Methotrexate | 25mg/ml | - | > 240 | > 240 | |
| Mitomycin C | 0.5mg/ml | - | > 240 | > 240 | |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 | > 240 | |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 | > 240 | |
| Thiotepa | 10.0mg/ml | 30.2 | 30.1 | 1.9 | |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 | > 240 | |
| Warning Statement | *WARNING: Do | ||||
| Not Use with | |||||
| Carmustine and | |||||
| Thiotepa. |
Carmustine
and Thiotepa
has extremely
low
permeation
time of less
than 30
minutes
respectively | *WARNING:
Please note that
the following
drugs have
extremely low
permeation
times:
Carmustine:
15.0 minutes
and ThioTepa:
30.1 minutes.
NOT TO BE
USED WITH
CARMUSTINE
OR THIOTΕΡΑ | * WARNING: Please
note that the following
drugs have extremely
low permeation times:
Carmustine: 1.82
minutes and ThioTepa:
0.93 minutes. NOT
TO BE USED WITH
CARMUSTINE OR
THIOTEPA | |
Таыь 2
8
| Characteristics | ||||
|---|---|---|---|---|
| Predicate | ||||
| K161215 | Subject Device | |||
| Blue | Subject Device | |||
| Cobalt Blue | Comparison | |||
| Water tightness | ||||
| (1000ml) | Passes | Passes | Passes | Same |
| Color | Sterling/Grey | Blue | Cobalt Blue | Different |
| Material | Nitrile | Nitrile | Nitrile | Same |
| Size | Extra Small | |||
| Small | ||||
| Medium | ||||
| Large | ||||
| Extra Large | Extra Small | |||
| Small | ||||
| Medium | ||||
| Large | ||||
| Extra Large | Extra Small | |||
| Small | ||||
| Medium | ||||
| Large | ||||
| Extra Large | Same | |||
| Texture | Finger Textured | Finger Textured | Finger | |
| Textured | Same | |||
| Single Use | Single Use | Single Use | Single Use | Same |
| Expiration claim | No Expiration Date Claimed | 5 years | 5 years | Different |
| Bio-compatibility | Passes | |||
| Not primary skin irritant under the | ||||
| conditions of the study. | Passes | |||
| Under the condition of the study the | ||||
| device is non-irritant | Passes | |||
| Under the condition of the study | ||||
| the device is non-irritant | Same | |||
| Passes | ||||
| Not a contact sensitizer under the | ||||
| conditions of the study. | Passes | |||
| Under the condition of the study the | ||||
| device in non-sensitizer | Passes | |||
| Under the condition of the | ||||
| study the device in non- | ||||
| sensitizer | Same |
Table 3
Page 5 of 7
9
| Indications for Use | |||
|---|---|---|---|
| A patient Examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. | Same | |
| Tested Chemotherapy Drug And Concentration | Average Break through Detection Time | Similar | |
| Carmustine (3.3 mg/ml) | |||
| Cisplatin (BCNU), 1.0 mg/ml | |||
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | |||
| Dacarbazine (DTIC), 10.0 mg/ml | |||
| Doxorubicin Hydrochloride, 2.0 mg/ml | |||
| Etoposide (Toposar), 20.0 mg/ml | |||
| Fluorouracil, 50.0 mg/ml | |||
| Ifosfamide , 50.0 mg/ml | |||
| Methotrexate, 25 mg/ml | |||
| Mitomycin C, 0.5 mg/ml | |||
| Mitoxantrone, 2 mg/ml | |||
| Paclitaxel (Taxol), 6.0 mg/ml | |||
| ThioTEPA (10.0 mg/ml) | |||
| Vincristine Sulfate, 1.0 mg/ml | 5.4 min |
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
40.4 min
240 min | |
| | | Carboplatin, 10 mg/ml
Carmustine (3.3 mg/ml)
Cisplatin (BCNU), 1.0 mg/ml
Cyclophosphamide (Cytoxan), 20.0 mg/ml
Dacarbazine (DTIC), 10.0 mg/ml
Doxorubicin Hydrochloride, 2.0 mg/ml
Etoposide (Toposar), 20.0 mg/ml
Fluorouraci1, 50.0 mg/ml
Ifosfamide , 50.0 mg/ml
Methotrexate, 25 mg/ml
Mitomycin C, 0.5 mg/ml
Mitoxantrone, 2 mg/ml
Paclitaxel (Taxol), 6.0 mg/ml
ThioTEPA (10.0 mg/ml)
Vincristine Sulfate, 1.0 mg/ml | |
| | | >240 min
15.0 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
30.1 min
240 min | |
| | | Carboplatin, 10mg/ml
Carmustine (3.3 mg/ml)
Cisplatin (BCNU), 1.0 mg/ml
Cyclophosphamide (Cytoxan), 20.0 mg/ml
Dacarbazine (DTIC), 10.0 mg/ml
Doxorubicin Hydrochloride, 2.0 mg/ml
Etoposide (Toposar), 20.0 mg/ml
Fluorouracil, 50.0 mg/ml
Ifosfamide , 50.0 mg/ml
Methotrexate, 25 mg/ml
Mitomycin C, 0.5 mg/ml
Mitoxantrone, 2 mg/ml
Paclitaxel (Taxol), 6.0 mg/ml
ThioTEPA (10.0 mg/ml)
Vincristine Sulfate, 1.0 mg/ml | |
| | | >240 min
2.4 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
240 min
1.9 min
240 min | |
| | Tested for use with Chemotherapy Drugs.
Carmustine has extremely low permeation time of less than 30 minutes | The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 15.0 min ThioTEPA (10.0 mg/ml): 30.1 min | Same |
| | | The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 2.4 min
ThioTEPA (10.0 mg/ml): 1.9 min | |
10
8.0 Conclusion
The subject devices are as safe, as effective, and perform as well or better than the legally marketed predicate device K161215 (Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs).
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