(83 days)
Not Found
No
The device is a patient examination glove, and the summary describes standard testing for physical properties, biocompatibility, and chemotherapy drug permeation, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, and is not designed to treat a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or health condition.
No
The device is a physical examination glove, which is a hardware medical device, not software. The 510(k) summary describes physical properties, material composition, and performance testing related to a tangible product.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The described device is a patient examination glove. Its primary function is to act as a barrier to prevent contamination between a patient and an examiner. While it has been tested for use with chemotherapy drugs, this testing relates to the glove's barrier properties and safety for the user, not to analyzing a patient specimen for diagnostic purposes.
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This aligns with a barrier device, not a diagnostic one.
- Lack of Diagnostic Elements: The description, performance studies, and key metrics all focus on the physical properties, barrier function, and safety of the glove itself (dimensions, strength, pinholes, protein content, chemotherapy drug permeation). There is no mention of analyzing patient samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, this patient examination glove is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
Carmustine (BCNU) (3.3 mg/ml) 15.4
Cisplatin (1.0 mg/ml) > 240
Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240
Cytarabine (100 mg/ml) > 240
Dacarbazine (DTIC) (10.0 mg/ml) > 240
Doxorubicin Hydrochloride (2.0 mg/ml) > 240
Etoposide (20.0 mg/ml) > 240
Fluorouracil (50.0 mg/ml) > 240
Ifosfamide (50.0 mg/ml) > 240
Methotrexate (25 mg/ml) > 240
Mitomycin C (0.5 mg/ml) > 240
Mitoxantrone (2.0 mg/ml) > 240
Paclitaxel (Taxol) (6.0 mg/ml) > 240
Thiotepa (10.0 mg/ml) 30.6
Vincristine Sulfate (1.0 mg/ml) > 240
Please note that the following drugs - Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively.
Product codes (comma separated list FDA assigned to the subject device)
80 LYY, 80 LZC
Device Description
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 applicable ASTM standards, including ASTM D3578-05 (2010) for dimensions, physical properties, and freedom from pinholes; ASTM D6124-11 for powder-free residue; ASTM D5712-10 for protein content; ISO 10993-10:2010 for biocompatibility (dermal sensitization and primary skin irritation); and ASTM D6978-05 for chemotherapy drug permeation. The device met all standard requirements for dimensions, physical properties (tensile strength and elongation before and after aging), freedom from pinholes (Pass quality level at G1 AQL 1.5), powder-free residue (≤ 2 mg/glove), protein content (≤ 50 microgram/dm2), and biocompatibility (not a contact skin sensitizer, not a primary skin irritant). Permeation testing was conducted for 15 chemotherapy drugs; most showed breakthrough times >240 minutes, with Carmustine (15.4 minutes) and Thiotepa (30.6 minutes) being exceptions.
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
K123819
MAR 0 5 2013
FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information
Date: 01 March 2013
1.0 Submitter:
Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, Malaysia
| Telephone No .: | +603 3291 0516 |
|---|---|
| Fax No .: | +603 3291 0542 |
2.0 Contact Person:
| Contact: | Ms Rosnita Maodin |
|---|---|
| Telephone No.: | +603 3291 0516 |
| Fax No .: | +603 3291 0542 |
3.0 Name of Device:
Trade Name: Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm- of glove or Less of Water Extractable Protein)
Common Name : Patient Examination Glove Classification Name : Patient Examination Glove Regulation Number : 21 CFR 880.6250 Classification Number: Class I Product Code : 80 LYY, 80 LZC
4.0 Identification of the Legally Marketed Device:
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein), Class I patient examination gloves, Latex - 80 LY Y, Specialty - 80 LZC, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove.
Predicate Device: K083409, Powder Free Blue Latex Patient Examination Glove, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50 ug/dm2 per glove of Extractable Protein).
Page 1 of 7 (Rev 3)
1
5.0 Description of Device:
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).
6.0 Intended Use of the Device:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
| Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes) |
|---|
| ------------------------------------------------------------------------------- |
| Carmustine (BCNU) (3.3 mg/ml) | 15.4 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 30.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drugs - Carmustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively.
2
7.0 Summary of the Technological Characteristics of the Device:
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards
Requirements | Results Summary | Conclusions |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D 3578-05
(2010) | Length
≥ 270mm
Palm Thickness
≥ 0.20mm
Finger Thickness
≥ 0.25mm
Width
X-Small 70-80mm
Small 80-90mm
Medium 90-100mm
Large 101-111mm
X-Large ≥ 111mm | Meets
Standard
Requirements |
| Physical
Properties | ASTM D 3578-05
(2010) | Before Aging After Aging
Tensile Strength
≥ 18 MPA ≥ 14 MPA
Elongation
≥ 650% ≥ 500% | Meets
Standard
Requirements |
| Freedom from
pinholes | ASTM D 5151-11
ASTM D 3578-05
(2010) | Tested in accordance with ASTM D5151 test
method. Pass quality level at G1 AQL 1.5 | Meets
Standard
Requirements |
| Powder Free
Residue | ASTM D 6124-11
ASTM D 3578-05
(2010) | Result generated values ≤ 2 mg of residual powder
per glove | Meets
Standard
Requirements |
| Protein Content | ASTM D 5712-10
ASTM D 3578-05
(2010) | Result generated values ≤ 50 microgram/dm2 | Meets
Standard
Requirements |
| Biocompatibility | Dermal Sensitization
(as ISO 10993-
10:2010)
Primary Skin Irritation
Test (as ISO 10993-
10:2010) | Not a contact skin sensitizer
Not a primary skin irritant | Meets
Standard
Requirements |
| Chemotherapy
Drugs
Permeation Test
Method | ASTM D6978-05 | Chemotherapy Drug Permeation
(Minimum Breakthrough Detection Time in Minutes)
Carmustine (3.3 mg/ml) 15.4
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide (20.0 mg/ml) >240
Cytarabine (100 mg/ml) >240
Dacarbazine (DTIC) (10.0 mg/ml) >240
Doxorubicin Hydrochloride
(2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
Fluorouracil (50.0 mg/ml) >240
Ifosfamide (50.0 mg/ml) >240
Methotrexate (25 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Mitoxantrone (2.0 mg/ml) >240
Paclitaxel (Taxol) (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) 30.6
Vincristine Sulfate (1.0 mg/ml) >240 | Tested for Use
with
Chemotherapy
Drugs.
Carmustine
and Thiotepa
have
extremely
short
permeation
times of 15.4
and 30.6
minutes,
respectively. |
Page 3 of 7 (Rev 3)
3
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein) has been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.
There is no different between the proposed device and the predicate with respect to performance standard and technological characteristics.
The predicate device was tested for nine drugs, while proposed device tested for 15 drugs. Respective drug's permeation result is shown in Indication for Use of the proposed device. The different in labeling (with additional drugs tested, exceed ASTM D6978-05 requirements), and in Indications for Use (with permeation results added) does not affect the safety and effectiveness of the proposed device.
9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data is not needed for market cleared examination gloves.
10.0 Conclusion
It can be concluded that the Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm- of glove or Less of Water Extractable Protein), is as safe and effective as, the current legally marketed device identified in this 510(k) summary.
The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the proposed device and the predicate device for the substantial equivalent determination.
The gloves are Substantial Equivalent to predicate device cleared under 510(k) K083409.
4
Substantial Equivalent Comparison Table
| Characteristics | Predicate Device | Proposed Device |
|---|---|---|
| K083409, Powder Free Blue | ||
| Latex Patient Examination | ||
| Glove, Tested for use with | ||
| Chemotherapy Drugs with a | ||
| Protein Content Label Claim | ||
| ( $≤50 ug/dm²$ per glove of | ||
| Extractable Protein) | Powder Free Latex Patient | |
| Examination Glove, Blue, Tested | ||
| for Use with Chemotherapy Drugs, | ||
| with Protein Content Labeling | ||
| Claim (Contains 50 Micrograms | ||
| per dm² of glove or less of Water | ||
| Extractable Protein) | ||
| Device | ||
| Description/ | ||
| Regulation | ||
| Number | Patient Examination Glove/ | |
| 21 CFR Part 880.6250 | Substantial Equivalent | |
| Product Code | 80 LYY, 80 LZC | Substantial Equivalent |
| Intended Use | Intended for medical purposes | |
| that is worn on the examiner's | ||
| hand to prevent contamination | ||
| between patient and examiner. | Substantial Equivalent | |
| Characteristics | Predicate Device | Proposed Device |
| K083409, Powder Free Blue | ||
| Latex Patient Examination | ||
| Glove, Tested for use with | ||
| Chemotherapy Drugs with a | ||
| Protein Content Label Claim | ||
| (≤50 ug/dm² per glove of | ||
| Extractable Protein) | Powder Free Latex Patient | |
| Examination Glove, Blue, with | ||
| Protein Content and Chemotherapy | ||
| Drugs Labeling Claim (Contains | ||
| 50 Micrograms per dm² of glove or | ||
| less of Water Extractable Protein) | ||
| Indications for Use | The powder free chemotherapy | |
| examination glove is a specialty | ||
| medical. glove which is a | ||
| disposable device intended for | ||
| medical purposes that is worn | ||
| on the examiner's hand or | ||
| forefinger to prevent | ||
| contamination between | ||
| examiner and patient bodily | ||
| fluids, waste and environment. | ||
| Tested for use with | ||
| chemotherapy drugs. Tested | ||
| chemotherapy drugs are as | ||
| follows [Cyclophosphamide, | ||
| Carmustine, Thio-Tepa, | ||
| Dacarbazine, Doxorubicin | ||
| Hydrochloride, 5-Fluorouracil, | ||
| Cisplatin, Etoposide, and | ||
| Paclitaxel] |
Warning: Do not use gloves
with Thio-tepa and
Carmustine. | A patient examination glove is a
disposable device intended for
medical purposes that is worn on
the examiner's hand to prevent
contamination between patient and
examiner.
This glove has been tested for use
with specific chemotherapy drugs
listed below.
Chemotherapy Drug Permeation
(Minimum Breakthrough Detection
Time in Minutes)
Carmustine (3.3 mg/ml) 15.4
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide
(20.0 mg/ml) >240
Cytarabine (100 mg/ml) >240
Dacarbazine (DTIC)
(10.0 mg/ml) >240
Doxorubicin Hydrochloride
(2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
Fluorouracil (50.0 mg/ml) >240
Ifosfamide (50.0 mg/ml) >240
Methotrexate (25 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Mitoxantrone (2.0 mg/ml) >240
Paclitaxel (Taxol) (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) 30.6
Vincristine Sulfate (1.0 mg/ml) >240
Please note that the following drugs
-
Carmustine and Thiotepa have
extremely short permeation times of
15.4 and 30.6 minutes, respectively. |
| Design | Ambidextrous, in different
sizes per ASTM D3578
dimension requirement | Substantial Equivalent |
| Characteristics | Predicate Device | Proposed Device |
| Materials | Natural Rubber Latex | Substantial Equivalent |
| Color | Blue | Substantial Equivalent |
| Performance
I. Sterility
II. Freedom
from holes
III. Dimension
IV. Physical
Properties
V. Powder Free
Residue
VI. Protein
Content | K083409, Powder Free Blue
Latex Patient Examination
Glove, Tested for use with
Chemotherapy Drugs with a
Protein Content Label Claim
( $\leq$ 50 ug/dm² per glove of
Extractable Protein) | Powder Free Latex Patient
Examination Glove, Blue, with
Protein Content and Chemotherapy
Drugs Labeling Claim (Contains
50 Micrograms per dm² of glove or
less of Water Extractable Protein) |
| | Not Applicable (Non-Sterile)
Passes at AQL 1.5
Meets ASTM D3578
Meets ASTM D3578
Meets $\leq$ 2 mg/glove
Meets $\leq$ 50 $\mu$ g/dm² | Substantial Equivalent
Passes at AQL 1.5 (Substantial
Equivalent)
Meets ASTM D3578 (Substantial
Equivalent)
Meets ASTM D3578 (Substantial
Equivalent)
Meets $\leq$ 2 mg/glove (Substantial
Equivalent)
Meets $\leq$ 50 $\mu$ g/dm² (Substantial
Equivalent) |
| Single Use | Yes | Substantial Equivalent |
| Biocompatibility
Test | Passes.
i. Primary Skin Irritation Test
ii. Dermal Sensitization Test | Substantial Equivalent
Substantial Equivalent |
| Packaging | Packed in Dispenser Boxes | Substantial Equivalent |
| Labeling Claim | i. With Extractable Protein
Content Labeling Claim
ii. Chemotherapy Drugs
Labeling Claim per ASTM
D6978-05 | Substantial Equivalent |
5
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6
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7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2013
Ms. Rosnita Maodin Quality Assurance Manager Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13 Shah Alam, Selangor Malaysia 40170
Re: K123819
Trade/Device Name: Powder Free Latex Patient Examination Glove, Blue Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LYY, LZC Dated: January 30, 2013
Received: February 4, 2013
Dear Ms. Moadin:
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. Iisting 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 - Ms. Maodin
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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,
Image /page/8/Picture/6 description: The image shows a logo or emblem with stylized text and geometric shapes. The text appears to be handwritten and somewhat illegible, possibly reading "For" at the top left, with other words like "with" and "without" incorporated into the design. The geometric shapes include a maze-like pattern on the left and a triangular structure on the right, giving the logo a complex and abstract appearance. The overall design is black and white and has a rough, hand-drawn quality.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Latex Patient Examination Glove, Blue Tested for Use with Chemotherapy Drugs, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.4 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 30.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drugs - Carnustine and Thiotepa have extremely short permeation times of 15.4 and 30.6 minutes, respectively
AND/OR Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
| Elizabeth | |
|---|---|
| Claverie | |
| 2013.03.05 16:12:07 -05'00' |
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: K123819
Page I of
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