(286 days)
Not Found
No
The device is a medical glove and the summary describes standard physical and chemical testing, with no mention of AI or ML.
No.
The device is described as a glove intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is a non-sterile disposable glove worn on the hand or finger to prevent contamination between patient and examiner. Its intended use is not for diagnosing medical conditions.
No
The device is a physical glove, not software. The description and performance studies clearly indicate it is a tangible product made of nitrile.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, 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 reiterates the intended use and function as a protective barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The testing performed focuses on the physical properties of the glove and its resistance to chemicals, which are relevant for a protective barrier device.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Rhino Non-Sterile Powder-Free Nitrile Patient Exam Glove - Blue Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/mL (3,300 ppm) | 23.1 |
| Cisplatin | 1.0 mg/mL (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | 20 mg/mL (20,000 ppm) | > 240 |
| Dacarbazine | 10 mg/mL (10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2,000 ppm) | > 240 |
| Etoposide (Toposar) | 20.0 mg/mL (20,000 ppm) | > 240 |
| Flurouracil | 50.0 mg/mL (50,000 ppm) | > 240 |
| Paclitaxel (Taxol) | 6.0 mg/mL (6,000 ppm) | > 240 |
| Thiotepa | 10.0 mg/mL (10,000 ppm) | 24.9 |
Fentanyl Tested as Follows: Fentanyl Citrate Injection (100mcg/2mL)
Note: Carmustine and Thiotepa have extremely low permeation times of 23.1 and 24.9minutes respectively. Warning: Do Not Use with Carmustine and Thiotepa
Product codes
LZA, LZC, QDO
Device Description
The Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Blue Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger (worn on examiner's hand or finger)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purposes
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: Non-clinical Testing.
The device was tested for compliance with ASTM D6319-19; Standard Specification for Nitrile Examination Gloves for Medical Application and ASTM D6978-05; Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biocompatibility evaluation was conducted in accordance with ISO 10993-10; Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization and ISO 10993-11; Biological Evaluation of Medical Devices – Part 11: Test for Systemic Toxicity.
Key Results:
- Freedom from holes: Medium: 0 leakers in 50, Large: 1 leaker in 50, 2 leakers in 100.
- Powder-free: Medium: 0.1 mg, Large: 0.4 mg.
- Ultimate elongation before and after aging: Medium: 563% (before), 528% (after); Large: 555% (before), 500% (after).
- Tensile Strength before and after aging: Medium: 44 MPa; Large: 38 MPa.
- Palm and Finger Thickness: Medium: 0.09 mm; Large: 0.08 mm.
- Palm Width: Medium: 93 mm; Large: 106 mm.
- Length: Medium: 236 mm; Large: 243 mm.
- Resistance to Permeation by Chemotherapy Drugs (Minimum Breakthrough Detection Time in Minutes):
- Carmustine (BCNU) (3.3mg/mL 3,300 ppm): 23.1
- Cisplatin (1.0 mg/mL 1,000ppm): > 240
- Cyclophosphamide (Cytoxan) (20 mg/mL 20,000 ppm): > 240
- Dacarbazine (10 mg/mL 10,000 ppm): > 240
- Doxorubicin Hydrochloride (2.0 mg/mL 2,000 ppm): > 240
- Etoposide (Toposar) (20.0mg/mL 20,000 ppm): > 240
- Flurouracil (50.0 mg/mL 50,000 ppm): > 240
- Paclitaxel (Taxol) (6.0 mg/mL 6,000 ppm): > 240
- Thiotepa (10.0 mg/mL 10,000 ppm): 24.9
- Fentanyl Citrate Injection (100 mcg/2mL): > 240
- Systemic Toxicity Test (ISO 10993-11): Test article meets the requirements; did not induce a significantly greater biological reaction than controls.
- Primary Skin Irritation on Rabbits (ISO 10993-10): The overall mean score of the test article was 0.4 and the overall mean score of the vehicle control was 0.4.
- Guinea Pig Sensitization (ISO 10993-10): 0% sensitization observed.
Key Metrics
- Permeation time (Minutes) for various chemotherapy drugs, ranging from 23.1 to > 240 minutes.
- Tensile strength (MPa)
- Ultimate elongation (%)
- Thickness (mm)
- Width (mm)
- Length (mm)
- Powder content (mg/glove)
- Leakers (number)
- Systemic Toxicity: Pass/Fail based on biological reaction compared to controls.
- Primary Skin Irritation: Mean score of test article compared to vehicle control.
- Sensitization: Percentage of sensitization observed.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2021
Rhino Health Inc % Lisa Capote Attorney of Record Capote Law Firm 13818 SW 152 Street Number 375 Miami. Florida 33177
Re: K203236
Trade/Device Name: Rhino Non-sterile Powder-Free Nitrile Exam Glove – Blue Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO Dated: July 15, 2021 Received: November 3, 2020
Dear Lisa Capote:
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,
Jiangsong Jiang -S (Affiliate)
For Clarence Murray 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) K203236
Device Name
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Blue Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
Rhino Non-Sterile Powder-Free Nitrile Patient Exam Glove - Blue Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/mL (3,300 ppm) | 23.1 |
| Cisplatin | 1.0 mg/mL (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | 20 mg/mL (20,000 ppm) | > 240 |
| Dacarbazine | 10 mg/mL (10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2,000 ppm) | > 240 |
| Etoposide (Toposar) | 20.0 mg/mL (20,000 ppm) | > 240 |
| Flurouracil | 50.0 mg/mL (50,000 ppm) | > 240 |
| Paclitaxel (Taxol) | 6.0 mg/mL (6,000 ppm) | > 240 |
| Thiotepa | 10.0 mg/mL (10,000 ppm) | 24.9 |
Fentanyl Tested as Follows: Fentanyl Citrate Injection (100mcg/2mL)
Note: Carmustine and Thiotepa have extremely low permeation times of 23.1 and 24.9minutes respectively. Warning: Do Not Use with Carmustine and Thiotepa
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
240
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3
510(k) Summary
510(K): K203236
Date Prepared: April 28, 2021
I. Submitter:
| Company Name: | Rhino Health Inc. |
|---|---|
| Establishment Reg. No: | 3014572471 |
| Address: | 309A East, Route 66 |
| Church Rock, New Mexico 87311 | |
| Phone Number: | 1-833-898-8989 |
| Contact Person: | Mark Lee |
| Title: | CEO |
| Phone Number: | 1-833-898-8989 |
| Fax Number: | N/A |
| Email Address: | MLee@RhinoHealth.net |
II. Device
| Type of 510(k): | Traditional |
|---|---|
| Proprietary Name: | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Blue Tested for |
| Use with Chemotherapy Drugs and Fentanyl Citrate | |
| Common Name: | Polymer Patient Examination Glove |
| Trade Name: | |
| Classification Name: | Non-Powdered Patient Examination Glove |
| Review Panel: | General Hospital |
| Product Code: | LZA, LZC, QDO |
| Regulatory Class: | Class 1, reserved |
| Regulation Number: | 21 CFR 880.6250 |
III. Predicate Device
| Applicant | Predicate Device | 510(k)
Number | Approval
Date |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------|
| Sri Trang Gloves
(Thailand) Public
Company
Limited | Non-Sterile, Powder Free Nitrile Exam Glove Tested
for use with Chemotherapy Drugs - Lilac, Non-Sterile,
Powder Free Nitrile Exam Glove Tested for use with
Chemotherapy Drugs - Orchid, Non-Sterile, Powder
Free Nitrile Exam Glove Tested for use with
Chemotherapy Drugs - Oyster | K193581 | March 20,
2020 |
4
IV. Device Description
The Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Blue Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows:
| Chemotherapy Drugs Tested as Follows: | ||
|---|---|---|
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 23.1 |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | (20 mg/mL 20,000 ppm) | > 240 |
| Dacarbazine | (10 mg/mL 10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | (2.0 mg/mL 2,000 ppm) | > 240 |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | > 240 |
| Flurouracil | (50.0 mg/mL 50,000 ppm) | > 240 |
| Paclitaxel (Taxol) | (6.0 mg/mL 6,000 ppm) | > 240 |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 24.9 |
| Fentanyl Opioid Tested as Follows: | ||
| Fentanyl Citrate Injection | (100 mcg/2mL) | > 240 |
Note: Carmustine and Thiotepa have extremely low permeation times of 23.1 and 24.9minutes respectively.
Warning: Do Not Use with Carmustine and Thiotepa
V. Intended Use:
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Blue Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
| Test Results Follow: | ||
|---|---|---|
| Chemotherapy Drug | Concentration | Minimum Breakthrough |
| Detection Time | ||
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 23.1 |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | (20 mg/mL 20,000 ppm) | > 240 |
| Dacarbazine | (10 mg/mL 10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | (2.0 mg/mL 2,000 ppm) | > 240 |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | > 240 |
| Flurouracil | (50.0 mg/mL 50,000 ppm) | > 240 |
| Paclitaxel (Taxol) | (6.0 mg/mL 6,000 ppm) | > 240 |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 24.9 |
| Fentanyl Tested as Follows: | ||
| Fentanyl Citrate Injection | (100 mcg/2mL) | > 240 |
Test Results Follow:
5
Note: Carmustine and Thiotepa have extremely low permeation times of 23.1 and 24.9 minutes respectively. Warning: Do Not Use with Carmustine and Thiotepa
VI. Comparison of Technological Characteristics with Predicate Device
| Characteristic | Standard | Subject Device | Predicate Device
K193581 | Remark |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Device Name &
Model: | | Non-sterile, Powder-Free
Nitrile Exam Glove
Model: RH001 | Non-sterile, Powder- Free
Nitrile Exam Glove | Different |
| 510(k) Number: | | K203236 | K193581 | Different |
| Product Codes: | | LZA, LZC, QDO | LZA, LZC, QDO | Identical |
| Regulation Number: | | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Regulation Class: | | Class I | Class I | Identical |
| Sterile vs. Non-Sterile: | | Non-Sterile | Non-Sterile | Identical |
| Prescription or OTC: | | OTC | OTC | Identical |
| Single-use Disposable: | | Yes | Yes | Identical |
| Indications for Use: | N/A | Rhino Non-Sterile Powder-
Free Nitrile Exam Gloves -
Blue Tested for Use with
Chemotherapy Drugs and
Fentanyl is non-sterile
disposable device intended for
medical purposes that is worn
on the examiner's hand or
finger to prevent
contamination between patient
and examiner
Chemotherapy Drug's
Concentration at Minimum
Breakthrough Detection Time:
Carmustine
(BCNU)(3.3mg/mL 3,300
ppm) 23.1
Cisplatin (1.0 mg/mL 1,000
ppm) > 240
Cyclophosphamide (Cytoxan)
(20 mg/mL 20,000 ppm) >
240
Dacarbazine (10 mg/mL
10,000 ppm) > 240
Doxorubicin Hydrochloride
(2.0 mg/mL 2,000 ppm) > 240
Etoposide (Toposar) (20.0
mg/mL 20,000 ppm) > 240
Flurouracil (50.0 mg/mL
50,000 ppm) > 240
Paclitaxel (Taxol) (6.0 mg/mL
6,000 ppm) > 240
Thiotepa (10.0 mg/mL 10,000
ppm) 24.9
Fentanyl Tested as
Follows:Fentanyl Citrate
Injection (100 mcg/2mL)> | This device is a disposable
device intended for medical
purpose that is worn on the
examiner's hand to prevent
contamination between
patient and examiner.
Bleomycin Sulfate 15 mg/mL,
240 minutes
Busulfan 6 mg/mL, >240
minutes
Carboplatin (Paraplatin) 10
mg/mL, >240 minutes
Carmustine (BCNU) 3.3
mg/mL, 17.1 minutes
Cisplatin 1.0 mg/mL, >240
minutes
Cyclophosphamide (Cytoxan)
20 mg/mL, >240 minutes
Cytarabine 100 mg/mL, >240
minutes
Dacarbazine (DTIC) IO
mg/mL, >240 minutes
Daunorubicin 5 mg/mL, >240
minutes
Docetaxel IO mg/mL, >240
minutes
Doxorubicin Hydrochloride 2
mg/mL, >240 minutes
Epirubicin (Ellence) 2
mg/mL, >240 minutes
Etoposide (Toposar) 20
mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240
minutes
Fluorouracil 50 mg/mL, >240
minutes | Similar |
| Caution/Warning
Statements: | N/A | WARNING – Not for
use with Carmustine
and Thiotepa | WARNING – Not
for use with Carmustine and
Thiotepa | Identical |
| Dimensions: Overall
Length: | ASTM D6319 | Minimum: 230 mm
Large: 237 mm | 238 mm | Similar |
| Dimensions: Palm
Width (mm): | ASTM D6319
Minimum:
XS: 70 ± 10
S: 80 ± 10
M: 95 ± 10
L: 110 ± 10
XL: 120 ± 10 | M: 90 – 100
L: 103 – 113
N/A | N/A
N/A
110
N/A | Similar |
| Dimensions: Palm &
Finger Thickness
(mm): | ASTM D6319
Minimum
Palm: 0.05
Finger: 0.05 | Large:
Palm: 0.08 mm
Finger: 0.12 mm | Palm: 0.05 mm
Finger: 0.08 mm | Similar |
| Tensile strength:
Before & After aging: | ASTM D6319
Min.
Before: 14MPa
After: 14Mpa | Large:
Before: 36.8 MPa
After: 39.1 MPa | Before: 34 MPa
After: 38 MPa | Similar |
| Ultimate elongation | ASTM D6319 | Minimum: | Before: 570% | Similar |
| Before & After aging: | | Before: 500%, After: 400%
Large:
Before: 540%, After: 490% | After: 535% | |
| Freedom from holes: | ASTM D6319
G1, AQL 2.5
7 Accept
8 Reject | Medium: No leakers in 50
Large: 1 leaker in 50
2 leakers in 100 | Pass | Identical |
| Powder-Free | ASTM D6319
Maximum
240
Cisplatin (1.0 mg/mL
1,000 ppm) > 240
Cyclophosphamide
(Cytoxan) (20 mg/mL
20,000 ppm) > 240
Dacarbazine (10mg/mL
10,000 ppm) > 240
Doxorubicin
Hydrochloride (2.0
mg/mL 2,000 ppm) > 240
Etoposide (Toposar) (20.0
mg/mL 20,000 ppm) >
240
Flurouracil (50.0 mg/mL
50,000 ppm) > 240
Paclitaxel (Taxol) (6.0
mg/mL 6,000 ppm) > 240 | Permeation time (Minutes):
Carmustine (BCNU) (3.3mg/mL
3,300 ppm), 23.1
Cisplatin (1.0 mg/mL 1,000ppm)
240
Cyclophosphamide (Cytoxan) (20
mg/mL
20,000 ppm) > 240
Dacarbazine (10 mg/mL
10,000 ppm) > 240
Doxorubicin Hydrochloride (2.0
mg/mL 2,000 ppm) >
240
Etoposide (Toposar) (20.0mg/mL
20,000 ppm) > 240
Flurouracil (50.0 mg/mL 50,000
ppm) > 240
Paclitaxel (Taxol) (6.0
mg/mL 6,000 ppm)
240
Thiotepa (10.0 mg/mL 10,000
ppm) 24.9 |
| | | | |
| | | Thiotepa (10.0 mg/mL
10,000 ppm) > 240
Fentanyl Citrate Injection
(100 mcg/2mL) > 240 | Fentanyl Citrate Injection (100
mcg/2mL) > 240 |
| ISO 10993-11
Systemic
Toxicity Test | Determine the
potential toxic
effects of the
test article
extract as a
result of a
single-dose
systemic
injection in
mice. | Test passes if none of the
animals injected show a
significantly greater
biological reaction than
the animals treated with
the control article. | The USP 0.9% Sodium Chloride
for Injection and Cottonseed Oil
extracts of the test article, RHUSA
Nitrile glove, did not induce a
significantly greater biological
reaction than the control extracts
following a single dose to Albino
Swiss mice. Based on the criteria of
the protocol, the test article meets
the requirements of the ISO 10993-
11 guidelines. |
| ISO 10993-10
Primary Skin
Irritation on
Rabbits | Determine the
potential
irritation
effects of the
test article
extract as a
result of an
intracutaneous
injection in
New Zealand
white rabbits | The requirements of the
test are met if the
difference between the test
article mean score and the
vehicle control mean score
is 1.0 or less. | The over mean score of the test
article was 0.4 and the overall mean
score of the vehicle control was 0.4. |
| ISO 10993-10
Guinea Pig
Sensitization | Determine the
potential
allergenic or
sensitizing
capacity of the
test article | A sensitizer is a test
article with which a
positive response is
observed in at least 10%
of the test animals. | 0% sensitization observed |
8
9
Biocompatibility: 1.
The biocompatibility evaluation for the body contacting components of Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Blue Tested for Use with Chemotherapy Drugs and Fentanyl was conducted in accordance with ISO 10993-10; Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization and ISO 10993-11; Biological Evaluation of Medical Devices – Part 11: Test for Systemic Toxicity.
2. Performance:
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves - Blue Tested for Use with Chemotherapy Drugs and Fentanyl was tested for compliance with ASTM D6319-19; Standard Specification for Nitrile Examination Gloves for Medical Application and ASTM D6978-05; Standard Practice for Assessment of Resistance of Medical Gloves to Permeation
10
by Chemotherapy Drugs.
VIII. Conclusion
The conclusions drawn from the nonclinical test demonstrate that the Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Blue Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device.