(124 days)
No
The device is a physical examination glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination between a patient and examiner, and not to treat a medical condition or disease.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between the patient and examiner, and is tested for use with chemotherapy drugs. It is not designed to diagnose any condition or disease.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the glove and its testing for chemotherapy drug permeation. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described are bench testing related to physical properties and chemotherapy drug permeation, not studies involving the analysis of biological specimens.
- Lack of IVD Indicators: There are no mentions of analyzing samples, diagnostic purposes, or any other characteristics typically associated with IVD devices.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / 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.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, white colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.
The gloves are designed and manufactured per ASTM D6319-10 standard and tested for use with chemotherapy drugs per ASTM D6978-05 (reapproved 2013).
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)
The biocompatibility evaluation for the Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
The following tests were performed to evaluate the biocompatibility of the Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs):
-. ISO 10993-10: Primary Skin Irritation
-. ISO 10993-10: Dermal Sensitization
- ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application ●
- ASTM D 6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical ● Gloves
- ASTM D 5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical ● Gloves
- ASTM D 6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Performance Testing (Bench)
Physical performance qualities were evaluated per ASTM D6319- 10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The gloves were tested according to ASTM D6978- 05 (Reapproved 2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2017
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K162982
Trade/Device Name: Medline Nitrile Powder-free Examination Glove With Colloidal Oatmeal USP (tested For Use With Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: January 31, 2017 Received: January 31, 2017
Dear Jennifer Mason:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education 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 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,
Susan Runne DDS, MA
For Tina Kiang, Ph.D. Acting Division 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) K162982
Device Name
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
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.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Blenoxane (Bleomycin) 15 mg/ml >240 minutes Bortezomib 1 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 11.9 minutes Cetuximab (Erbitux) 2 mg/ml >240 minutes Cisplatin 1.0 mg.ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Cytarabine 100 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Daunorubicin 5 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Ellence 2 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38 mg/ml >240 minutes Idarubicin 1 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 20.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5 mg/ml >240 minutes Methotrexate 25 mg/ml >240 minutes Methotrexate 50 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10 mg/ml >240 minutes Pemetrexed Disodium 25 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10 mg/ml >240 minutes Thiotepa 10.0 mg/ml 18.6 minutes Trisonex 0.1 mg/ml >240 minutes Vidaza (5-Azacytidine) 25 mg/ml >240 minutes Vinblastine 1 mg/ml >240 minutes
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Vinorelbine 10 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) (3.3 mg/ml) 11.9 minutes Thiotepa (10.0 mg/ml) 18.6 minutes
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. A gray bar is visible on the right side of the image.
K162982 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date February 27, 2017
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Patient Examination Glove (Tested for Use with Chemotherapy Drugs) Proprietary Name: Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LZA, LZC Classification Panel: General Hospital Regulation #: 21 CFR 880.6250
Predicate Device
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs K160562
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Image /page/5/Picture/0 description: The image features the logo for Medline, a medical supply company. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a stylized white cross. The cross is oriented diagonally, with its top point extending upwards and to the right. The background is a solid dark blue color, providing a strong contrast to the white text and cross. A small gray rectangle is visible in the upper right corner of the image.
e Medline Place
Reference Device
Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile. Tested for Use with Chemotherapy Drugs K151750
Device Description
The Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, white colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.
The gloves are designed and manufactured per ASTM D6319-10 standard and tested for use with chemotherapy drugs per ASTM D6978-05 (reapproved 2013).
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.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug Tested | Breakthrough Time
(in minutes) |
|---------------------------------------|-----------------------------------|
| Blenoxane 15 mg/ml | >240 |
| Bortezomib 1 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine (BCNU) 3.3 mg/ml | 11.9 |
| Cetuximab (Eributux) 2 mg/ml | >240 |
| 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 |
| Daunorubicin 5 mg/ml | >240 |
| Docetaxel 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue background. To the right of the word is a white star-like symbol with four points. The background is a solid blue color, providing a stark contrast to the white text and symbol.
| Fluorouracil 50.0 mg/ml | >240 |
|---|---|
| Gemcitabine (Gemzar) 38 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50.0 mg/ml | >240 |
| Irinotecan 20.0 mg/ml | >240 |
| Mechlorethamine HCI 1.0 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Methotrexate 50 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2.0 mg/ml | >240 |
| Oxaliplatin 5 mg/ml | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Pemetrexed Disodium 25 mg/ml | >240 |
| Raltitrexed 0.5 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10.0 mg/ml | 18.6 |
| Trisonex 0.1 mg/ml | >240 |
| Vidaza (5-Azacytidine) 25 mg/ml | >240 |
| Vinblastine 1 mg/ml | >240 |
| Vinorelbine 10 mg/ml | >240 |
| Vincristine Sulfate 1.0 mg/ml | >240 |
Please note that the following drugs have extremely low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 11.9 minutes
Thiotepa (10.0 mg/ml) 18.6 minutes
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Image /page/7/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with the letters stacked on top of each other. To the right of the word is a white starburst symbol. The background of the logo is a solid blue color.
Summary of Technological Characteristics
TABLE 1: Comparison of Proposed and Predicate Devices
| Device
Characteristic | Proposed
Device | Predicate
Device | Reference
Device | Comparison
Analysis |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Product Name | Medline Nitrile
Powder-Free
Examination Glove
with Colloidal
Oatmeal USP (Tested
for Use with
Chemotherapy Drugs) | Nitrile Powder Free
Examination Glove
with Colloidal
Oatmeal USP Tested
for Use with
Chemotherapy Drugs | Powder Free Nitrile
Patient Examination
Glove, White
Colored, Non Sterile.
Tested for Use with
Chemotherapy Drugs | N/A |
| 510(k) Reference | K162982 | K160562 | K151750 | N/A |
| Product Owner | Medline Industries,
Inc. | Hartalega | Kossan | Different |
| Product Code | LZA, LZC | LZA., LZC | LZA, LZC | Same |
| Intended 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.
These gloves were
tested for use with
chemotherapy drugs
as per ASTM D6978-
05 (Reapproved 2013)
Standard Practice for
Assessment of
Medical Gloves to
Permeation by
Chemotherapy Drugs | A non-sterile
disposable device
intended for medical
purpose that is worn
on the examiner's
hand to prevent
contamination
between patient and
examiner. These
gloves were tested
for use with
Chemotherapy Drugs
in accordance with
ASTM D6978-05,
Standard Practice for
Assessment of
Resistance of
Medical Gloves to
Permeation by
Chemotherapy Drugs | 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.
These gloves were
tested for use with
chemotherapy drugs
as per ASTM
D6978-05
(Reapproved 2013)
Standard Practice for
Assessment of
Medical Gloves to
Permeation by
Chemotherapy Drugs | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Nitrile
Colloidal oatmeal | Nitrile
Colloidal oatmeal | Nitrile | Same as K160562 |
| Color | White | White | White | Same |
| Sizes | x-small, small, medium, large, x-large | x-small, small, medium, large, x-large | x- small, small, medium, large, x-large, xx-large | Same |
| Dimensions – Length | Complies with ASTM D6319-10
230mm min. | Complies with ASTM D6319-10
240mm min. | Complies with ASTM D6319-10
230mm min. | Same as K151750 and similar to K160562 which is 10mm longer than the subject device. |
| Dimensions – Width | Complies with ASTM D6319-10
X-small – 70±10mm
Small – 80±10mm
Medium – 95±10mm
Large – 110±10mm
X-large – 120±10mm | Complies with ASTM D6319-10
Medium – 95mm | Complies with ASTM D6319-10
X-small – 70-80mm
Small – 80-90mm
Medium – 90-100mm
Large – 101-11mm
X-large – 111-121mm
XX-large – 121-131mm | Same as K160562 and similar to K151750. |
| Dimensions – Thickness | Complies with ASTM D6319-10
Palm – 0.05mm min.
Finger – 0.05mm min. | Complies with ASTM D6319-10
Palm – 0.07mm min.
Finger – 0.07mm min. | Complies with ASTM D6319-10
Palm – 0.05mm min.
Finger – 0.05mm min. | Same as K151750 and similar to K160562 |
| Physical Properties | Complies with ASTM D6319-10 minimum: | Complies with ASTM D6319-10 minimum: | Complies with ASTM D6319-10 minimum: | Same |
| | Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | |
| Freedom from Holes | Complies with ASTM D6319-10 and ASTM D5151-06
(reapproved 2011) G-1, AQL 1.5 | Complies with ASTM D6319-10 and ASTM D5151-06 (reapproved 2011) AQL 1.5 | Complies with ASTM D6319-10 and ASTM D5151-06 (reapproved 2011) G-1, AQL 1.5 | Same |
| Powder or Powder-Free | Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with ASTM D6319-10 240 min. | | | Different |
| | Bortezomib 1 mg/ml
240 min. | | | Different |
| | Busulfan 6 mg/ml
240 min. | | | Different |
| | Carmustine (BCNU)
3.3 mg/ml
11.9 min. | Carmustine
3.3 mg/ml
10.1 min. | Carmustine (BCNU)
3.3 mg/ml
10.1 min. | Same |
| | Cetuximab (Erbitux)
2 mg/ml
240 min. | | | Different |
| | Cisplatin 1.0 mg.ml
240 min. | Cisplatin 1.0 mg.ml
240 min. | Cisplatin 1.0 mg.ml
240 min. | Same |
| | Cyclophosphamide
(Cytoxan) 20.0 mg/ml
240 min. | Cyclophosphamide
(Cytoxan) 20 mg/ml
240 min. | Cyclophosphamide
(Cytoxan) 20 mg/ml
240 min. | Same |
| | Cytarabine 100 mg/ml
240 min. | | Cytarabine 100
mg/ml
240 min. | Different |
| | Dacarbazine
(DTIC)10.0 mg/ml
240 min. | Dacarbazine
(DTIC)10.0 mg/ml
240 min. | Dacarbazine
(DTIC)10.0 mg/ml
240 min. | Same |
| | Daunorubicin 5
mg/ml
240 min. | | | Different |
| | Docetaxel 10.0 mg/ml
240 min. | | | Different |
| | Doxorubicin
Hydrochloride 2.0
mg/ml
240 min. | Doxorubicin
Hydrochloride 2.0
mg/ml
240 min. | Doxorubicin
Hydrochloride 2.0
mg/ml
240 min. | Same |
| | Ellence 2 mg/ml
240 min. | | | Different |
| | Etoposide (Toposar)
20.0 mg/ml
240 min. | Etoposide (Toposar)
20.0 mg/ml
240 min. | Etoposide (Toposar)
20.0 mg/ml
240 min. | Same |
| | Fludarabine 25 mg/ml
240 min. | | | Different |
| Fluorouracil 50.0
mg/ml
240 min. | Fluorouracil 50.0
mg/ml
240 min. | Fluorouracil 50.0
mg/ml
240 min. | Same | |
| Gemcitabine
(Gemzar) 38 mg/ml
240 min. | | | Different | |
| Idarubicin 1 mg/ml
240 min. | | | Different | |
| Ifosfamide 50.0
mg/ml
240 min. | | Ifosfamide (IFEX)
50 mg/ml
240 min. | Different | |
| Irinotecan 20.0 mg/ml
240 min. | | | Different | |
| Mechlorethamine
HCI 1.0 mg/ml
240 min. | | | Different | |
| Melphalan 5 mg/ml
240 min. | | | Different | |
| Methotrexate 25
mg/ml
240 min. | Methotrexate 25
mg/ml
240 min | Methotrexate 25
mg/ml
240 min. | Same | |
| Methotrexate 50
mg/ml
240 min. | | | Different | |
| Mitomycin C 0.5
mg/ml
240 min. | Mitomycin C 0.5
mg/ml
240 min. | Mitomycin C 0.5
mg/ml
240 min. | Same | |
| Mitoxantrone 2.0
mg/ml
240 min. | | Mitoxantrone 2.0
mg/ml
240 min. | Different | |
| Oxaliplatin 5 mg/ml
240 min. | | | Different | |
| Paclitaxel (Taxol) 6.0
mg/ml
240 min. | Paclitaxel (Taxol)
6.0 mg/ml
240 min. | Paclitaxel (Taxol)
6.0 mg/ml
240 min. | Same | |
| Paraplatin 10 mg/ml
240 min. | | | Different | |
| Pemetrexed Disodium
25 mg/ml
240 min. | | | Different | |
| Raltitrexed 0.5 mg/ml
240 min. | | | Different | |
| Rituximab 10 mg/ml
240 min. | | | Different | |
| Thiotepa 10.0 mg/ml
18.6 min. | Thiotepa 10.0 mg/ml
30.4 min. | Thiotepa 10.0 mg/ml
10.4 min. | Same | |
| Trisonex 0.1 mg/ml
240 min | | | Different | |
| Vidaza (5-
Azacytidine) 25
mg/ml
240 min. | | | Different | |
| Vinblastine 1 mg/ml
240 min. | | | Different | |
| Vinorelbine 10 mg/ml
240 min. | | | Different | |
| Vincristine Sulfate
1.0 mg/ml
240 min. | Vincristine Sulfate
1.0 mg/ml
240 min. | Vincristine Sulfate
(Oncovin) 1.0 mg/ml
240 min. | Same | |
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Image /page/8/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The symbol is composed of four pointed shapes converging at a central point, creating a visual effect of radiating light or energy. The overall design is clean and professional, reflecting the company's presence in the medical or healthcare industry.
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Image /page/9/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is composed of four pointed shapes converging at a central point, creating a dynamic and modern design.
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Image /page/10/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, placed horizontally. A white, stylized cross is behind the text. The background is a solid dark blue.
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Image /page/11/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The word "MEDLINE" is prominently displayed in white, with a stylized white cross extending vertically through the text. The cross's upper and lower points extend beyond the word, adding a distinctive visual element to the logo. A small gray rectangle is visible in the upper right corner of the image.
Summary of Non-Clinical Testing
The biocompatibility evaluation for the Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
The following tests were performed to evaluate the biocompatibility of the Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs):
- . ISO 10993-10: Primary Skin Irritation
- . ISO 10993-10: Dermal Sensitization
- ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application ●
- ASTM D 6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical ● Gloves
- ASTM D 5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical ● Gloves
- ASTM D 6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Performance Testing (Bench)
Physical performance qualities were evaluated per ASTM D6319- 10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The gloves were tested according to ASTM D6978- 05 (Reapproved 2013), Standard
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Image /page/12/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is in white, sans-serif font, stacked on top of a white, stylized star shape. The star has four points, with the top and bottom points being longer than the side points.
Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs.
Summary of Clinical Testing
Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) is as safe and as effective for their intended use as the predicate device, the Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs, K160562.