(590 days)
Not Found
No
The 510(k) summary describes a physical medical glove and its performance characteristics related to material properties and resistance to chemotherapy drugs. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a protective barrier (glove) intended to prevent contamination between the examiner and patient, and to protect the wearer from chemotherapy drugs, not to treat a medical condition or disease.
No
This device is a medical glove designed for protection against contamination and chemotherapy drugs, not for diagnosing a medical condition.
No
The device is a physical product (gloves) and not software. The description focuses on material properties and performance against chemical permeation, not 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. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of these gloves is to prevent contamination between the examiner and patient and to protect the wearer from chemotherapy drugs. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on physical properties, material, and performance against chemical permeation. It does not mention any components or processes related to analyzing biological specimens.
- Performance Studies: The performance studies described are related to the physical integrity of the glove (dimensions, strength, freedom from holes, watertightness) and its resistance to chemical permeation. There are no studies related to analyzing biological samples or providing diagnostic information.
The device is a medical glove intended for protection and contamination prevention, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows:
Test Chemical and Concentration, Average Breakthrough Detection Time (minutes)
Cisplatin, 1.0 mg/ml, ≥ 240
Cyclophosphamide (Cytoxan), 20.0 mg/ml, ≥ 240
Cytarabine, 100 mg/ml, ≥ 240
Cytovene, 10 mg/ml, ≥ 240
Dacarbazine (DTIC), 10.0 mg/ml, ≥ 240
Docetaxel, 10.0 mg/ml, ≥ 240
Doxorubicin Hydrochloride, 2.0 mg/ml, ≥ 240
Etoposide (Toposar), 20.0 mg/ml, ≥ 240
Fluorouracil, 50.0 mg/ml, ≥ 240
Ifosfamide, 50.0 mg/ml, ≥ 240
Irinotecan Hydrochloride, 20 mg/ml, ≥ 240
Mechlorethamine HCI, 1.0 mg/ml, ≥ 240
Methotrexate, 25 mg/ml, ≥ 240
Mitomycin C, 0.5 mg/ml, ≥ 240
Mitoxantrone, 2 mg/ml, ≥ 240
Oxaliplatin, 5mg/ml, ≥ 240
Paclitaxel (Taxol), 6.0 mg/ml, ≥ 240
ThioTEPA, 75.8
Vincristine Sulfate, 1.0 mg/ml, ≥ 240
Vinorelbine, 10 mg/ml, ≥ 240
Low Permeation Time (minutes), 1.7
Carmustine (BCNU), 3.3 mg/ml, Not Found
Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)
Product codes (comma separated list FDA assigned to the subject device)
LZC
Device Description
Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner, medical purpose
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)
The device was tested against ASTM D6319-10 for dimensions, physical properties, and thickness, meeting standard requirements. Biocompatibility testing (Primary Skin Irritation per ISO 10993-0:2002E and Dermal Sensitization per ASTM-F 720-81) showed the device is not a primary skin irritant and not a contact sensitizer. Watertightness (Freedom from Holes) per 21 CFR 800.20 was tested at 1000 ml and passed. Resistance to Permeation by Chemotherapy Drugs was tested according to ASTM D6978-05, and the device met standard requirements, with specific breakthrough detection times for various chemotherapy drugs listed in a table.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough Detection Time (minutes) for various chemotherapy drugs.
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
MAR 1 4 2012
K 102189
510(k) SUMMARY
1.0 Submitter:
Latexx Manufacturing Sdn. Bhd. Name: Address: Lot 18374. Kamunting Industrial Estate 34600 Taiping, Perak Malaysia Phone: 605 891 1111 605 829 5590 Fax: Contact Person: Ooi Loon Seng (Madam)
Date of Preparation: February 10, 2012
2.0 Name of Device:
Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Gloves, Specialty Chemotherapy (21 CFR 880.6250 Product Code LZC)
510(k) Number: K102189
Legally Marketed Device to Which Equivalence is being Claimed: 3.0
Primary Predicate: Cardinal Health Esteem Tru-Blu Stretchy Nitrile Exam Gloves 510(k) Number: K032444
Additional Predicate: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim 510(k) Number: K022765
4.0 Description of the Device:
Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim, meeting all the requirements of ASTM standards D6319-10 and ASTM D6124-06. The gloves are non-sterile, single-use, disposable devices.
Additional Information requested 24 February 2012
Page 4 of 10 27 February 2012
1
5.0 Indications for Use:
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested chemotherapy drugs are as follows:
| Test Chemical and Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Cisplatin, 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| Cytarabine, 100 mg/ml | ≥ 240 |
| Cytovene, 10 mg/ml | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| Docetaxel, 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | ≥ 240 |
| Ifosfamide, 50.0 mg/ml | ≥ 240 |
| Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 |
| Mechlorethamine HCI, 1.0 mg/ml | ≥ 240 |
| Methotrexate, 25 mg/ml | ≥ 240 |
| Mitomycin C, 0.5 mg/ml | ≥ 240 |
| Mitoxantrone, 2 mg/ml | ≥ 240 |
| Oxaliplatin, 5mg/ml | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| ThioTEPA | 75.8 |
| Vincristine Sulfate, 1.0 mg/ml | ≥ 240 |
| Vinorelbine, 10 mg/ml | ≥ 240 |
| Low Permeation Time (minutes) | 1.7 |
| Carmustine (BCNU), 3.3 mg/ml |
Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)
Latexx Manufacturing Sdn. Bhd.
Additional Information requested 24 February 2012
Page 5 of 10 27 February 2012
2
6.0 Summary of Technological Characteristics of the Device:
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim have the following technological characteristics compared to ASTM or equivalent standards:
| Characteristics | Standard | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets standard requirements |
| Physical Properties | ASTM D6319-10 | Meets standard requirements |
| Thickness | ASTM D6319-10 | Meets standard requirements |
| Biocompatibility | Primary Skin Irritation | |
| Study (ISO 10993-0:2002E) | ||
| Dermal Sensitization | ||
| (ASTM-F 720-81) | Passes (Not a primary skin | |
| irritant) | ||
| Passes (Not a contact | ||
| sensitizer) | ||
| Watertight - 1000 ml | ||
| (Freedom from Holes) | 21 CFR 800.20 | Passes |
| Resistance to Permeation | ||
| by Chemotherapy Drugs | ASTM D6978-05 | Meets standard requirements |
Latexx Manufacturing "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim" demonstrated the following breakthrough detection times when tested according to ASTMD6978-05
| Test Chemical and Concentration | Average Breakthrough
Detection Time (minutes) |
|---------------------------------------------------------------|--------------------------------------------------|
| Cisplatin, 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| Cytarabine, 100 mg/ml | ≥ 240 |
| Cytovene, 10 mg/ml | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| Docetaxel, 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | ≥ 240 |
| Ifosfamide, 50.0 mg/ml | ≥ 240 |
| Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 |
| Mechlorethamine HCl, 1.0 mg/ml | ≥ 240 |
| Methotrexate, 25 mg/ml | ≥ 240 |
| Mitomycin C, 0.5 mg/ml | ≥ 240 |
| Mitoxantrone, 2 mg/ml | ≥ 240 |
| Oxaliplatin, 5mg/ml | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml. | ≥ 240 |
| Thiotepa | 75.8 |
| Vincristine Sulfate, 1.0 mg/ml | ≥ 240 |
| Vinorelbine, 10 mg/ml | ≥ 240 |
| Low Permeation Time (minutes)
Carmustine (BCNU), 3.3 mg/ml | 1.7 |
Latexx Manufacturing Sdn. Bhd.
Additional Information requested 24 February 2012
Page 6 of 10 27 February 2012
3
- Substantial Equivalence Based on Assessment of Non-Clinical Performance Data: 7.0
Comparison to Predicate and Non-Clinical Testing - The subject device (Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim) compares favorably to the predicate device (Cardinal Health Esteem Tru-Blu Stretchy Nitrile Exam Gloves) as indicated in the tabulated summaries to follow.
Substantial Equivalence Comparison of Indications for Use
The Indications for Use statements for the subject nitrile gloves and the cited predicate, as listed below, are substantially equivalent (SE).
| Indications for
Use –
Subject Device: | The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy
Drugs Labeling Claim is a specialty medical glove which is a disposable device
intended for medical purpose that is worn on the examiner's hand or finger to
prevent contamination between examiner and patient. In addition these gloves are
worn to protect the wearer against exposure to chemotherapy drugs. Tested
chemotherapy drugs are as follows: | |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Powder-Free
Nitrile
Examination
Gloves Tested for
Use with
Chemotherapy
Drugs Labeling
Claim | Test Chemical and Concentration | Average Breakthrough Detection Time
(minutes) |
| | Cisplatin, 1.0 mg/ml | ≥ 240 |
| | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| | Cytarabine, 100 mg/ml | ≥ 240 |
| | Cytovene, 10 mg/ml | ≥ 240 |
| | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| | Docetaxel, 10.0 mg/ml | ≥ 240 |
| | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| | Fluorouracil, 50.0 mg/ml | ≥ 240 |
| | Ifosfamide, 50.0 mg/ml | ≥ 240 |
| | Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 |
| | Mechlorethamine HCI, 1.0 mg/ml | ≥ 240 |
| | Methotrexate, 25 mg/ml | ≥ 240 |
| | Mitomycin C, 0.5 mg/ml | ≥ 240 |
| | Mitoxantrone, 2 mg/ml | ≥ 240 |
| | Oxaliplatin, 5mg/ml | ≥ 240 |
| | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| | ThioTEPA | 75.8 |
| | Vincristine Sulfate, 1.0 mg/ml | ≥ 240 |
| | Vinorelbine, 10 mg/ml | ≥ 240 |
| | Low Permeation Time
(minutes)Carmustine BCNU), 3.3 mg/ml | 1.7 |
| Please note that the following drug has an extremely low permeation time: Carmustine
(BCNU) 1.7 (mins) | | |
Page 7 of 10 27 February 2012
4
| Indications for Use -
Predicate Device: | These examination gloves are disposable devices intended for
medical purposes that are worn on the examiner's hands or
fingers to prevent contamination between patient and examiner. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardinal Health Esteem Tru-Blu
Stretchy Nitrile Gloves (Nitrile
Powder-Free Examination Gloves
with Lotion Coating, Blue with
Use for Chemotherapy)
Cardinal Healthcare
Corporation K032444) | In addition, these gloves are worn to protect the wearer against
exposure to chemotherapy drugs. |
Comparisons of non-clinical biocompatibility and engineering bench tests are included in the summary table below. ·
| | Subject Device
Powder-Free Nitrile
Examination Gloves Tested for
Use with Chemotherapy Drugs
Labeling Claim | Predicate Device
Cardinal Health Esteem Tru-
Blu Stretchy Nitrile Gloves
(Nitrile Powder-Free
Examination Gloves with
Lotion Coating, Blue with Use
for Chemotherapy) | Substantial
Equivalence
(SE)? |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | | Cardinal Healthcare
Corporation K032444) | |
| Chemotherapy
Permeation
Standard | Meets ASTM D6978-05 | Meets ASTM D6978-05 | Yes |
| Design
Specifications &
Glove
Performance | Meets ASTM D6319-10:
-Tensile Strength ≥ 14MPa
(≥14MPa per Standard)
-Elongation ≥400% (≥400% per
Standard) | Meets ASTM D6319-00:
-Tensile Strength 19MPa (≥14
MPa per Standard)
-Elongation 533% (≥400% per
Standard) | Yes |
| Freedom from
Holes | Meets Requirements per
21CFR800.20:
Gloves Free of Holes at quality
level of AQL 1.5 (AQL 2.5
required per standard) | Meets Requirements per
21CFR800.20:
Gloves Free of Holes at quality
level of AQL 1.5 (AQL 2.5
required per standard) | Yes |
| Glove Thickness
and Length | Meets ASTM D6319-10:
-Palm Thickness of ≥0.10 mm
-Finger Thickness ≥0.10 mm
-Length ≥270 mm | Meets ASTM D6319-10:
-Palm Thickness average 0.10
mm
-Finger Thickness average 0.13
mm
-Length average 246 mm | Yes |
| Materials | Flexible Nitrile | Flexible Nitrile | Yes |
Substantial Equivalence Comparison Table – Engineering and Bench Testing
Latexx Manufacturing Sdn. Bhd.
Additional Information requested 24 February 2012
Page 8 of 10 27 February 2012
5
Substantial Equivalence Comparison Table - Engineering and Bench Testing (continued)
| | Subject Device
Powder-Free Nitrile
Examination Gloves Tested for
Use with Chemotherapy Drugs
Labeling Claim | Predicate Device
Cardinal Health Esteem Tru-
Blu Stretchy Nitrile Gloves
(Nitrile Powder-Free
Examination Gloves with
Lotion Coating, Blue with Use
for Chemotherapy)
Cardinal Healthcare
Corporation K032444) | Substantial
Equivalence
(SE)? |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Color | Synthetic Glove with embedded
BLUE Biocompatible Colorant | Synthetic Glove with embedded
BLUE Biocompatible Colorant | Yes |
| Technology of
Glove Design,
i.e. Coatings
and/or Donning
Aid | Ambidextrous;
Inner Glove Surface Chlorine
Treated to Facilitate Donning;
Fingertips Textured to Improve
Tactility and Grip | Ambidextrous;
Lotion Coating on Inner Surface
as Donning Aid:
Outer Surface Textured to
Improve Grip | Yes |
| Biocompatibility | Passes tests for :
-Primary Skin Irritation
-Dermal Sensitization | Passes tests for:
-Primary Skin Irritation
-Dermal Sensitization | Yes |
| Powder-Free | Meets Applicable Definition for
Powder Free; Trade Name: Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim Regulation Number: 21 CFR 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: February 27, 2012 Received: March 14, 2012
Dear Mr. Burris:
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.
8
Page 2- Mr. Burris
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.Β.Α.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
9
INDICATIONS FOR USE
Applicant: LATEXX MANUFACTURING SDN. BHD., LOT 18374, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia
510(k) Number: K102189
Device Name: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
Indications For Use:
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows:
| Test Chemical and Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Cisplatin, 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| Cytarabine, 100 mg/ml | ≥ 240 |
| Cytovene, 10 mg/ml | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| Docetaxel, 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | ≥ 240 |
| Ifosfamide, 50.0 mg/ml | ≥ 240 |
| Irinotecan Hydrochloride, 20 mg/ml | ≥ 240 |
| Mechlorethamine HCI, 1.0 mg/ml | ≥ 240 |
| Methotrexate, 25 mg/ml | ≥ 240 |
| Mitomycin C, 0.5 mg/ml | ≥ 240 |
| Mitoxantrone, 2 mg/ml | ≥ 240 |
| Oxaliplatin, 5mg/ml | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| ThioTEPA | 75.8 |
| Vincristine Sulfate, 1.0 mg/ml | ≥ 240 |
| Vinorelbine, 10 mg/ml | ≥ 240 |
| Low Permeation Time (minutes) | 1.7 |
| Carmustine (BCNU), 3.3 mg/ml |
Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 1.7 (mins)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use
Per 21 CFR 801.109
OR Over-The-Counter
×
Elisha F. Marine-Willen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________