Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove

K203236 · Rhino Health, Inc. · LZA · Aug 16, 2021 · General Hospital

Device Facts

• Record ID: K203236
• Device Name: Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
• Applicant: Rhino Health, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Aug 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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

Device Story

Non-sterile, powder-free nitrile examination glove; worn on examiner's hand/finger to prevent cross-contamination between patient and examiner. Device provides barrier protection during medical procedures. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978. Used in clinical settings by healthcare professionals. Output is physical barrier protection; informs clinical decision-making regarding appropriate personal protective equipment (PPE) selection for handling hazardous drugs. Benefits patient and clinician by reducing exposure to contaminants and chemotherapy agents. Warning: Do not use with Carmustine and Thiotepa due to low permeation times.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM D6319 (physical properties: freedom from holes, tensile strength, elongation, dimensions) and ASTM D6978 (chemotherapy drug permeation). Biocompatibility evaluated per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity). Results confirm compliance with standards and safety for intended use.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free, non-sterile, single-use disposable glove. Standards: ASTM D6319 (physical properties), ASTM D6978 (chemotherapy permeation). Biocompatibility: ISO 10993-10, ISO 10993-11. No energy source or software components.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and fentanyl citrate.

Regulatory Classification

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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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.

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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 [phone] 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

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## 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) |

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# 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<br>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: | [e-mail] |

# II. Device

| Type of 510(k): | Traditional |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Blue Tested for<br>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)<br>Number | Approval<br>Date |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------|
| Sri Trang Gloves<br>(Thailand) Public<br>Company<br>Limited | Non-Sterile, Powder Free Nitrile Exam Glove Tested<br>for use with Chemotherapy Drugs - Lilac, Non-Sterile,<br>Powder Free Nitrile Exam Glove Tested for use with<br>Chemotherapy Drugs - Orchid, Non-Sterile, Powder<br>Free Nitrile Exam Glove Tested for use with<br>Chemotherapy Drugs - Oyster | K193581 | March 20,<br>2020 |

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## 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<br>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:

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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<br>K193581 | Remark |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Device Name &<br>Model: | | Non-sterile, Powder-Free<br>Nitrile Exam Glove<br>Model: RH001 | Non-sterile, Powder- Free<br>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-<br>Free Nitrile Exam Gloves -<br>Blue Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl is non-sterile<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner<br>Chemotherapy Drug's<br>Concentration at Minimum<br>Breakthrough Detection Time:<br>Carmustine<br>(BCNU)(3.3mg/mL 3,300<br>ppm) 23.1<br>Cisplatin (1.0 mg/mL 1,000<br>ppm) > 240<br>Cyclophosphamide (Cytoxan)<br>(20 mg/mL 20,000 ppm) ><br>240<br>Dacarbazine (10 mg/mL<br>10,000 ppm) > 240<br>Doxorubicin Hydrochloride<br>(2.0 mg/mL 2,000 ppm) > 240<br>Etoposide (Toposar) (20.0<br>mg/mL 20,000 ppm) > 240<br>Flurouracil (50.0 mg/mL<br>50,000 ppm) > 240<br>Paclitaxel (Taxol) (6.0 mg/mL<br>6,000 ppm) > 240<br>Thiotepa (10.0 mg/mL 10,000<br>ppm) 24.9<br>Fentanyl Tested as<br>Follows:Fentanyl Citrate<br>Injection (100 mcg/2mL)> | This device is a disposable<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>Bleomycin Sulfate 15 mg/mL,<br>>240 minutes<br>Busulfan 6 mg/mL, >240<br>minutes<br>Carboplatin (Paraplatin) 10<br>mg/mL, >240 minutes<br>Carmustine (BCNU) 3.3<br>mg/mL, 17.1 minutes<br>Cisplatin 1.0 mg/mL, >240<br>minutes<br>Cyclophosphamide (Cytoxan)<br>20 mg/mL, >240 minutes<br>Cytarabine 100 mg/mL, >240<br>minutes<br>Dacarbazine (DTIC) IO<br>mg/mL, >240 minutes<br>Daunorubicin 5 mg/mL, >240<br>minutes<br>Docetaxel IO mg/mL, >240<br>minutes<br>Doxorubicin Hydrochloride 2<br>mg/mL, >240 minutes<br>Epirubicin (Ellence) 2<br>mg/mL, >240 minutes<br>Etoposide (Toposar) 20<br>mg/mL, >240 minutes<br>Fludarabine 25 mg/mL, >240<br>minutes<br>Fluorouracil 50 mg/mL, >240<br>minutes | Similar |
| Caution/Warning<br>Statements: | N/A | WARNING – Not for<br>use with Carmustine<br>and Thiotepa | WARNING – Not<br>for use with Carmustine and<br>Thiotepa | Identical |
| Dimensions: Overall<br>Length: | ASTM D6319 | Minimum: 230 mm<br>Large: 237 mm | 238 mm | Similar |
| Dimensions: Palm<br>Width (mm): | ASTM D6319<br>Minimum:<br>XS: 70 ± 10<br>S: 80 ± 10<br>M: 95 ± 10<br>L: 110 ± 10<br>XL: 120 ± 10 | M: 90 – 100<br>L: 103 – 113<br>N/A | N/A<br>N/A<br>110<br>N/A | Similar |
| Dimensions: Palm &<br>Finger Thickness<br>(mm): | ASTM D6319<br>Minimum<br>Palm: 0.05<br>Finger: 0.05 | Large:<br>Palm: 0.08 mm<br>Finger: 0.12 mm | Palm: 0.05 mm<br>Finger: 0.08 mm | Similar |
| Tensile strength:<br>Before & After aging: | ASTM D6319<br>Min.<br>Before: 14MPa<br>After: 14Mpa | Large:<br>Before: 36.8 MPa<br>After: 39.1 MPa | Before: 34 MPa<br>After: 38 MPa | Similar |
| Ultimate elongation | ASTM D6319 | Minimum: | Before: 570% | Similar |
| Before & After aging: | | Before: 500%, After: 400%<br>Large:<br>Before: 540%, After: 490% | After: 535% | |
| Freedom from holes: | ASTM D6319<br>G1, AQL 2.5<br>7 Accept<br>8 Reject | Medium: No leakers in 50<br>Large: 1 leaker in 50<br>2 leakers in 100 | Pass | Identical |
| Powder-Free | ASTM D6319<br>Maximum<br><2mg/glove | Pass<br>Medium: 0.1 mg<br>Large: 0.4 mg | Pass | Identical |
| Biocompatibility | ISO 10993-11<br>Systemic<br>Toxicity<br>Test | Under the conditions of the<br>study, the extracts of the test<br>article did not induce a<br>significantly greater<br>biological reaction then the<br>control extracts. Based on the<br>criteria of the protocol, the<br>test article meets the<br>requirements of the ISO<br>10993-11 guidelines. | The device extracts did not<br>elicit a systemic response in<br>the animal model. | Similar |
| | ISO 10993-10<br>Primary<br>Skin<br>Irritation on<br>Rabbits | Under the conditions of the<br>study, the test article sites<br>did not show a significantly<br>greater biological reaction<br>than the sites injected with<br>the control article. The test<br>article meets the<br>requirements of ISO 10993-<br>10 guidelines. | Under the conditions of the<br>study, the polar and non-polar<br>device extracts were found not<br>to be an irritant to the animal<br>model | Similar |
| | ISO 10993-10<br>Guinea Pig<br>Sensitization | Under the conditions of the<br>study, the extracts of the<br>device elicited no reaction.<br>Therefore, as defined b the<br>grading scale of the USP, the<br>test article is classified as a<br>non-sensitizer. The test<br>article meets the<br>requirements of ISO 10993- | Under the conditions of the<br>study, the polar and non-polar<br>device extracts were found not<br>to be sensitizers to the animal<br>model. | Similar |

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## RHINO HEALTH, INC.

For more details, please refer to the Substantial Equivalence Discussion section in this submission.

#### Summary of Non-clinical Testing VII.

The following performance data was provided to demonstrate the subject device meets the acceptance criteria of the standard shown in the table below:

| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6319 | Freedom from<br>holes | AQL 2.5: 8 rejection level | Medium: 0 leakers in 50<br>Large: 1 leaker in 50<br>2 leakers in 100 |
| ASTM D6319 | Powder-free | Maximum <2mg/glove | Medium: 0.1 mg<br>Large: 0.4 mg |
| ASTM D6319 | Ultimate<br>elongation<br>before and<br>after aging | Minimum<br>Before Aging: 500%<br>After Aging: 400% | Medium: 563%<br>Large: 555%<br>Medium: 528%<br>Large: 500% |
| ASTM D6319 | Tensile<br>Strength<br>before and<br>after aging | Minimum<br>Before: 14 MPa<br>After: 14 MPa | Medium: 44 MPa<br>Large: 38 MPa |
| ASTM D6319 | Palm and<br>Finger<br>Thickness | Minimum:<br>Palm: 0.05 mm<br>Finger: 0.05 mm | Medium: 0.09 mm<br>Large: 0.08 mm |
| ASTM D6319 | Palm Width | Minimum<br>Medium: 95 mm ± 10<br>Large: 110 mm ± 10 | Medium: 93 mm<br>Large: 106 mm |
| ASTM D6319 | Length | Minimum:<br>230 mm | Medium: 236 mm<br>Large: 243 mm |
| ASTM D6978 | Resistance to<br>Permeation by<br>Chemotherapy<br>Drugs | Permeation time<br>(Minutes):<br>Carmustine (BCNU)<br>(3.3mg/mL 3,300 ppm) ><br>240<br><br>Cisplatin (1.0 mg/mL<br>1,000 ppm) > 240<br><br>Cyclophosphamide<br>(Cytoxan) (20 mg/mL<br>20,000 ppm) > 240<br><br>Dacarbazine (10mg/mL<br>10,000 ppm) > 240<br><br>Doxorubicin<br>Hydrochloride (2.0<br>mg/mL 2,000 ppm) > 240<br><br>Etoposide (Toposar) (20.0<br>mg/mL 20,000 ppm) ><br>240<br><br>Flurouracil (50.0 mg/mL<br>50,000 ppm) > 240<br><br>Paclitaxel (Taxol) (6.0<br>mg/mL 6,000 ppm) > 240 | Permeation time (Minutes):<br>Carmustine (BCNU) (3.3mg/mL<br>3,300 ppm), 23.1<br><br>Cisplatin (1.0 mg/mL 1,000ppm)<br>> 240<br><br>Cyclophosphamide (Cytoxan) (20<br>mg/mL<br>20,000 ppm) > 240<br><br>Dacarbazine (10 mg/mL<br>10,000 ppm) > 240<br><br>Doxorubicin Hydrochloride (2.0<br>mg/mL 2,000 ppm) ><br>240<br><br>Etoposide (Toposar) (20.0mg/mL<br>20,000 ppm) > 240<br><br>Flurouracil (50.0 mg/mL 50,000<br>ppm) > 240<br><br>Paclitaxel (Taxol) (6.0<br>mg/mL 6,000 ppm)<br>> 240<br><br>Thiotepa (10.0 mg/mL 10,000<br>ppm) 24.9 |
| | | | |
| | | Thiotepa (10.0 mg/mL<br>10,000 ppm) > 240<br><br>Fentanyl Citrate Injection<br>(100 mcg/2mL) > 240 | Fentanyl Citrate Injection (100<br>mcg/2mL) > 240 |
| ISO 10993-11<br>Systemic<br>Toxicity Test | Determine the<br>potential toxic<br>effects of the<br>test article<br>extract as a<br>result of a<br>single-dose<br>systemic<br>injection in<br>mice. | Test passes if none of the<br>animals injected show a<br>significantly greater<br>biological reaction than<br>the animals treated with<br>the control article. | The USP 0.9% Sodium Chloride<br>for Injection and Cottonseed Oil<br>extracts of the test article, RHUSA<br>Nitrile glove, did not induce a<br>significantly greater biological<br>reaction than the control extracts<br>following a single dose to Albino<br>Swiss mice. Based on the criteria of<br>the protocol, the test article meets<br>the requirements of the ISO 10993-<br>11 guidelines. |
| ISO 10993-10<br>Primary Skin<br>Irritation on<br>Rabbits | Determine the<br>potential<br>irritation<br>effects of the<br>test article<br>extract as a<br>result of an<br>intracutaneous<br>injection in<br>New Zealand<br>white rabbits | The requirements of the<br>test are met if the<br>difference between the test<br>article mean score and the<br>vehicle control mean score<br>is 1.0 or less. | The over mean score of the test<br>article was 0.4 and the overall mean<br>score of the vehicle control was 0.4. |
| ISO 10993-10<br>Guinea Pig<br>Sensitization | Determine the<br>potential<br>allergenic or<br>sensitizing<br>capacity of the<br>test article | A sensitizer is a test<br>article with which a<br>positive response is<br>observed in at least 10%<br>of the test animals. | 0% sensitization observed |

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#### 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; Biologi…