(102 days)
Not Found
No
The device is a physical examination glove and the summary focuses on material properties and resistance to chemicals, with no mention of AI/ML.
No
Explanation: This device is a patient examination glove, intended to prevent contamination between patient and examiner. It is a barrier device, not a therapeutic one that treats or mitigates a disease or condition.
No
Explanation: The device is described as a non-sterile disposable glove intended for medical purposes worn on the examiner's hand to prevent contamination. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of synthetic copolymers, and the performance studies focus on physical properties and resistance to substances, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "non-sterile 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 during medical examinations.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This device does not perform any such tests.
- Device Description: The description focuses on the physical characteristics and materials of the glove, not on any diagnostic capabilities.
- Performance Studies: The performance studies listed evaluate the physical properties, barrier function, and biocompatibility of the glove, which are relevant to its intended use as a protective barrier, not as a diagnostic tool.
The testing for use with chemotherapy drugs, fentanyl, and simulated gastric acid relates to the glove's ability to act as a barrier against these substances, which is a safety and performance characteristic for a protective glove, not a diagnostic function.
N/A
Intended Use / Indications for Use
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examiner's hand
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 subject 510(k) device has undergone a series of safety and performance tests. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specifications:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (FDA Recognition number 6-446)
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves (FDA Recognition number 6-424)
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves (FDA Recognition number 6-178)
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (FDA Recognition number 6-147)
- ISO 2859-1:1999 Sampling Procedures and Tables for Inspection by Attributes. (FDA Recognition number 5-88)
- ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension (FDA Recognition number 8-596)
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven (No FDA Recognition number)
- ASTM D3767-03 (2020) Standard Practice for Rubber Measurement of Dimensions (No FDA Recognition number)
- ASTM D7103-19 Standard guide for assessment of medical gloves (FDA Recognition number 6-444)
- ANSI/AAMI/ISO 10993-23:2021(E) - Biological evaluation of medical devices -Part 23: Tests for irritation (FDA Recognition number 2-291)
- ANSI/AAMI/ISO 10993-10:2021(E)- Biological evaluation of medical devices -Part 10: Tests for skin sensitization (FDA Recognition number 2-296)
- ANSI/AAMI/ISO 10993-11:2017(E) – Biological evaluation of medical devices – Part 11: Tests for systemic toxicity. (FDA Recognition number 2-255)
- ANSI/AAMI/ISO 10993-12:2021(E) - Biological evaluation of medical devices - Part 12: Sample preparation and reference material. (FDA Recognition number 2-289)
- ANSI/AAMI/ISO 10993-2:2022(E) - Biological evaluation of medical devices -Part 2: Animal welfare requirements (FDA Recognition number 2-222)
Key Results:
- Dimensions (Length, Width, Finger thickness, Palm thickness): Meets requirements of ASTM D 6319.
- Physical Properties (Tensile Strength, Ultimate elongation): Meets requirements of ASTM D 6319.
- Freedom from Pinholes: Meets requirements of ASTM D 6319, ASTM D 5151 (No leakage, AQL 2.5).
- Powder - Free: Meets requirements of ASTM D 6124, ASTM D 6319 (≤ 2 mg / glove).
- ISO Irritation Study (ISO 10993, Part 23): Primary Irritation Index ≤ 0.4. Under the conditions of the study the device is not an irritant.
- ISO Systemic Toxicity Study (ISO 10993, Part 11): No animals treated with test extracts exhibit greater reaction than control animals. No evidence of Acute systemic toxicity.
- ISO Dermal Sensitization (ISO 10993, Part 10): Grade
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 21, 2023
Kimberly-Clark Corporation % Amy Fowler Consultant Pathmaker FDA Law, P.L.L.C. 1415 Lilac Drive N; Suite 270 Minneapolis, Minnesota 55422
Re: K231021
Trade/Device Name: KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO Dated: April 10, 2023 Received: April 10, 2023
Dear Amy Fowler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K231021
Device Name
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Indications for Use (Describe)
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs,
Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Chemotherapy Drugs, Concentrations, and Minimum Breakthrough Detection Times
| Chemotherapy Drug | Concentration | Minimum Breakthrough
Detection Time |
|---------------------|--------------------------|----------------------------------------|
| Avastin | 25 mg/mL (25,000 ppm) | >240 min. |
| Cabazitaxel | 60 mg/1.5mL (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/mL (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/mL (3,300 ppm) | 76.6 min. |
| Cisplatin | 1 mg/mL (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/mL (20,000 ppm) | >240 min. |
| Dacarbazine | 10 mg/mL (10,000 ppm) | >240 min. |
| Doxorubicin HCL | 2 mg/mL (2,000 ppm) | >240 min. |
| Eribulin Mesylate | 0.5 mg/mL (500 ppm) | >240 min. |
| Etoposide | 20 mg/mL (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/mL (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/mL (50,000 ppm) | >240 min. |
| Ifosfamide | 50 mg/mL (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/mL (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/mL (2,000 ppm) | >240 min. |
| Oxaliplatin | 2 mg/mL (2,000 ppm) | >240 min. |
| Paclitaxel | 6 mg/mL (6,000 ppm) | >240 min. |
| Pemetrexed | 25 mg/mL (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/mL (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/mL (2,000 ppm) | >240 min. |
| ThioTEPA | 10 mg/mL (10,000 ppm) | 78.5 min. |
| Vinblastine Sulfate | 1 mg/mL (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/mL (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/mL (10,000 ppm) | >240 min. |
Table continued page 2-2.
3
Indications for Use
510(k) Number (if known)
K231021
Device Name
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Indications for Use (Describe)
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Non-Chemotherapy Drugs, Concentrations, and Minimum Breakthrough Detection Times, continued
| Fentanyl/Gastric Acid | Concentration | Minimum Breakthrough
Detection Time |
|----------------------------------------------------------------|----------------------------------------|----------------------------------------|
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid Fluid | 0.2% (w/v) NaCl in 0.7% (v/v) HCl acid | >240 min. |
| Simulated Gastric Acid Fluid/Fentanyl
Citrate Injection Mix | 50/50 mix solution | >240 min. |
Caution: The following chemotherapy drugs have low permeation (3.3mg/ml): 76.6 minutes and ThioTEPA (10 mg/ml): 78.5 minutes respectively.
| Type of Use (Select one or both, as applicable) | |
|---|---|
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to the requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
K231021
1. Submission Information
| Date Prepared: | |
|---|---|
| Submission Format: | Traditional 510(k) |
| 510(k) #: | K231021 |
2. Submitter Information
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| Address: | 1400 Holcomb Bridge Road |
| Roswell, Georgia 30076 | |
| Phone: | +1 770 587 8000 |
| Contact person: | Kimberly Tempas
Associate Director, Regulatory Affairs |
|-----------------|-----------------------------------------------------------|
| | 2100 Winchester Road
Neenah, WI 54956 |
| Phone: | +1 (920) 721-4084 |
| Email: | Kimberly. Tempas@kcc.com |
3. Device Information
| Trade Name: | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl
Citrate, Simulated Gastric Acid and Fentanyl in Simulated
Gastric Acid |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Nitrile powder-free patient exam glove for use with
chemotherapy drugs and fentanyl |
| Classification Name: | Patient Examination Glove |
| Regulation: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
5
| Panel: | General Hospital | ||
|---|---|---|---|
| Product Codes: | LZA, LZC, QDO, OPJ |
| Product codes | |
|---|---|
| LZA | Polymer Patient Examination Glove |
| LZC | Patient Examination Glove, Specialty |
| QDO | Fentanyl and other opioid protection gloves |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims |
4. Predicate Device Information
K200072 Powder-free Nitrile Exam Glove for use with Chemotherapy drugs and Fentanyl Product Code: LZC, LZA, QDO.
5. Device Description
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
6. Indications for Use
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
6
| Chemotherapy Drug | Concentration | Minimum Breakthrough
Detection Time |
|-------------------------------------------------------------------|----------------------------------------|----------------------------------------|
| Avastin | 25 mg/mL (25,000 ppm) | >240 min. |
| Cabazitaxel | 60 mg/1.5mL (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/mL (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/mL (3,300 ppm) | 76.6 minutes |
| Cisplatin | 1 mg/mL (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/mL (20,000 ppm) | >240 min. |
| Dacarbazine | 10 mg/mL (10,000 ppm) | >240 min. |
| Doxorubicin HCL | 2 mg/mL (2,000 ppm) | >240 min. |
| Eribulin Mesylate | 0.5 mg/mL (500 ppm) | >240 min. |
| Etoposide | 20 mg/mL (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/mL (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/mL (50,000 ppm) | >240 min. |
| Ifosfamide | 50 mg/mL (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/mL (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/mL (2,000 ppm) | >240 min. |
| Oxaliplatin | 2 mg/mL (2,000 ppm) | >240 min. |
| Paclitaxel | 6 mg/mL (6,000 ppm) | >240 min. |
| Pemetrexed | 25 mg/mL (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/mL (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/mL (2,000 ppm) | >240 min. |
| ThioTEPA | 10 mg/mL (10,000 ppm) | 78.5 minutes |
| Vinblastine Sulfate | 1 mg/mL (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/mL (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/mL (10,000 ppm) | >240 min. |
| Fentanyl/Gastric Acid | Concentration | Minimum Breakthrough
Detection Time |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid Fluid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Simulated Gastric Acid
Fluid/Fentanyl Citrate Injection
Mix | 50/50 mix solution | >240 min. |
Table 5.2. Permeation Times for Chemotherapy Drugs
Caution: The following chemotherapy drugs have low permeation times: Carmustine (3.3mg/ml): 76.6 minutes and ThioTEPA (10 mg/ml): 78.5 minutes respectively.
- Predicate & Subject Technological Characteristics Comparison Table
Table 5.3. Comparison between Subject and Predicate Devices
7
| Attributes | Standard Where
Limits Test Limits
Set | Purple
K200072
(Predicate) | Polaris
(Subject Device) | Comparison |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Regulation | NA | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Product
Codes | NA | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Same |
| Common
Name | NA | Examination glove | Examination
glove | Same |
| Sizes | NA | Five sizes:
XS, S, M, L, XL | Five sizes:
XS, S, M, L, XL | Same |
| Base
Material | NA | Nitrile | Nitrile | Same |
| Color | NA | Purple | Dark Magenta | Similar:
Biocompatibility
& physical
attributes testing
show that the
difference in
color does not
alter glove
safety or
performance. |
| Glove
formulation | NA | KC Purple Nitrile
9.5 Chemo
Formulation | Proprietary
formula | Similar:
Formulations
share similar
materials and
physical
characteristics;
biocompatibility
and physical
properties
testing show that
the subject
device's
formulation does
not reduce glove
safety or
performance. |
| Glove layers | NA | Single layer | Single layer | Same |
| Sterile or
Non- Sterile | NA | Non-Sterile | Non-Sterile | Same |
| Prescription
or OTC | NA | OTC | OTC | Same |
| Single Use
Disposable | NA | Yes | Yes | Same |
| Intended
Use/indicatio
ns for use | NA | The device is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hand or
finger to prevent
contamination
between patients
and examiner.
KIMTECHTM Purple
NitrileTM Powder free
Examination Gloves
are Tested for Use
with Chemotherapy
Drugs, Opioid
Fentanyl Citrate,
Simulated Gastric
Acid, and Fentanyl in
Simulated Gastric
Acid. | The nitrile
powder free
patient
examination
glove is a non-
sterile disposable
device intended
for medical
purposes that is
worn on the
examiner's hand
to prevent
contamination
between patient
and examiner.
In addition to
routine
examination
glove's intended
use, the gloves
are Tested for
Use with
Chemotherapy
Drugs, Opioid
Fentanyl Citrate,
Simulated
Gastric Acid and
Fentanyl in
Simulated
Gastric Acid. | Similar:
The subject
device removed
"or finger"
because it is
intended to be
worn on the
hand, not the
finger. |
| Attributes | Standard Where
Limits Test Limits
Set | Purple
K200072
(Predicate) | Polaris
(Subject Device) | Comparison |
| Indications
for Use
claims: | Chemotherapy
drugs tested for
permeation and
degradation in
accordance with
ASTM D6978-05
(2019) | Chemotherapy
Drugs Tested:
- Carmustine
- Cyclophosphami
de - Doxorubicin HCL
- Etoposide
- Fluorouracil
- Mitoxantrone
- Paclitaxel
- ThioTEPA
- Dacarbazine
- Ifosfamide
- Vincristine
Sulfate - Bleomycin Sulfate
- Busulfan
- Cytarabine
- Dacarbazine
- Daunorubicin
- Docetaxel
- Epirubicin
- Fludarabine
- Gemcitabine
- Idarubicin
- Mechlorethamine
HCL - Melphalan
- Methotrexate
- Mitomycin C
- Osplaten
- Paraplatin
- Rituximab | Chemotherapy
Drugs Tested: - Avastin
- Cabazitaxel
- Capecitabine
- Carmustine
- Cisplatin
- Cyclophospha
mide - Dacarbazine
- Doxorubicin
HCL - Eribulin
Mesylate - Etoposide
- Floxuridine
- Fluorouracil
- Ifosfamide
- Lenvatinib
- Mitoxantrone
- Oxaliplatin
- Paclitaxel
- Pemetrexed
- Sorafenib
Tosylate - Tamoxifen
- ThioTEPA
- Vinblastine
Sulfate - Vincristine
Sulfate - Vinorelbine | Similar: Both
have been
tested with a
common list of
chemotherapy
drugs in
accordance
with the same
test method,
but the subject
glove has been
tested for some
different
chemotherapy
drugs to better
meet current
user and
chemotherapy
treatment
needs. |
| Attributes | Standard Where
Limits Test
Limits Set | Purple
K200072(Predicate) | Polaris
(Subject Device) | Comparison |
| Permeation
and
degradation
tests of
other
substances | ASTM D6978-05
(2019) | Passed permeation
testing for:
Fentanyl citrate
Simulated gastric acid
50/50 mix of fentanyl
and gastric acid | Passed permeation
testing for:
Fentanyl citrate
Simulated gastric
acid
50/50 mix of
fentanyl and gastric
acid | Same |
| Carmustine
and
ThioTEPA
Permeation
time | ASTM D6978-05
(2019) | Carmustine: 3.6
minutes
ThioTEPA: 15.9
minutes | Carmustine: 76.6
minutes
ThioTEPA: 78.5
minutes | Similar: Both
gloves were
below the
minimum
permeation
time of 240
minutes
specified in the
standard. |
| Carmustine
and
ThioTEPA
Caution/
Warning
Statements | NA | WARNING: Not for use
with: Carmustine,
ThioTEPA | Caution: The
following
chemotherapy drugs
have low
permeation times:
Carmustine
(3.3mg/ml): 76.6
minutes and
ThioTEPA (10
mg/ml): 78.5
minutes
respectively. | Different: The
predicate has a
warning due to
extremely low
permeation
times while the
subject device
has a caution
statement
based on
permeation
times >70
minutes. |
| Dimensions:
Overall
length | ASTM D6319
Minimum:
230mm | All sizes comply with
length dimensions | All sizes comply with
length dimensions | Same |
| Dimensions:
Width (mean) | ASTM D6319
Minimum: 70
+10mm | All sizes comply with
width dimensions | All sizes comply
with width
dimensions | Same |
| Dimensions:
Palm & Finger
Thickness | ASTM D6319
Minimum Palm:
0.05mm
Minimum
Finger: 0.05mm | All sizes comply with
Palm & Finger Thickness
dimensions | All sizes comply with
Palm & Finger
Thickness
dimensions | Same |
| Attributes | Standard Where
Limits Test Limits
Set | Purple
K200072(Predicate) | Polaris
(Subject Device) | Comparison |
| Tensile
strength:
Before & After
Aging | ASTM D6319
Min Before: 14MPa
After: 14Mpa | Complies both
before and after
accelerated aging. | Complies both
before and after
accelerated aging. | Same |
| Ultimate
elongation
Before & After
aging | ASTM
D6319
Minimum: Before:
500%
After:400% | Complies both before
and after accelerated
aging. | Complies both
before and after
accelerated aging. | Same |
| Freedom from
pinholes | ASTM D6319 G1,
AQL 2.5
7 Accept
8 Reject | Pass
(AQL 1.5) | Pass
(AQL 0.65) | Same: Both
gloves pass
the tests.
The subject
glove AQL is
tighter and
allows fewer
pinhole
defects. |
| Powder-Free | ASTM D6319-19
(2019) Maximum