Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
Device Facts
| Record ID | K223859 |
|---|---|
| Device Name | Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl |
| Applicant | Rhino Health, Inc. |
| Product Code | LZA · General Hospital |
| Decision Date | Feb 13, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Periwinkle Color 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; periwinkle color; single-use. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and fentanyl per ASTM D6978-05. Input: physical contact with patient/substances. Output: physical barrier protection. Used in clinical settings. Healthcare provider wears glove to protect against patient contaminants and hazardous drug exposure. Benefits: provides barrier protection; reduces risk of contamination. Warning: do not use with Carmustine or Thiotepa due to low breakthrough times.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM D6319 (physical dimensions/properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder residue), ASTM D6978-05 (chemotherapy permeation), and ISO 10993-10/11 (biocompatibility/toxicity).
Technological Characteristics
Nitrile rubber; powder-free. Dimensions and physical properties per ASTM D6319. Permeation resistance tested per ASTM D6978-05. Biocompatibility per ISO 10993-10 and ISO 10993-11. Non-sterile, single-use, disposable.
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. Contraindicated for use with Carmustine and Thiotepa.
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
- Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl (K221082)
Related Devices
- K221082 — Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl · Rhino Health, Inc. · Nov 30, 2022
- K240629 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl · Xingyu Medical Tech Co., Ltd. · May 28, 2024
- K203236 — Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove · Rhino Health, Inc. · Aug 16, 2021
- K210730 — Nitrile Patient Examination Glove · American Performance Polymers, LLC · Aug 10, 2021
- K201530 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) · Hartalega NGC Sdn. Bhd. · Aug 5, 2020
Submission Summary (Full Text)
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February 13, 2023 Rhino Health Inc. % Lisa Capote Regulatory Counsel Capote Law Firm 13818 SW 152 Street Suite 375 Miami, Florida 33177
## Re: K223859
Trade/Device Name: Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl 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: December 12, 2022 Received: December 23, 2022
## 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 (1-800-638-2041 or 301-796-7100).
Sincerely.
# Bifeng Qian -S
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
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# Indications for Use
#### 510(k) Number (if known) K223859
#### Device Name
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves - Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl.
#### Indications for Use (Describe)
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves - Periwinkle Color 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 Drug | Concentration | Minimum Breakthrough Detection Time | |
|------------------------------------------|-------------------------|-------------------------------------|-------|
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 14.2 | |
| 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) | 43.2 | |
| Fentanyl Tested as Follows: | | | |
| Fentanyl Citrate Injection (100 mcg/2mL) | | | > 240 |
Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
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)
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# 510(k) Summary
510(K): K223859
Date Prepared: 02/13/2023
## 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: | MLee@RhinoHealth.net |
# II. Device
| Type of 510(k): | Traditional |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color<br>Tested for Use with Chemotherapy Drugs and Fentanyl |
| Common Name: | Polymer Patient Examination Glove |
| Trade Name: | |
| Classification Name: | Non-Powdered Patient Examination Glove |
| Review Panel: | General Hospital |
| Product Code: | LZA, LZC, OPJ, QDO |
| Regulatory Class: | Class 1, reserved |
| Regulation Number: | 21 CFR 880.6250 |
# III. Predicate Device
| Applicant | Predicate Device | 510(k) Number | Approval Date |
|-------------------|-------------------------------------------------------------------------------------------------------------------------|---------------|-------------------|
| Rhino Health, Inc | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl | K221082 | November 30, 2022 |
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## IV. Device Description
Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in three sizes, extra small, small, and extra large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows:
| Glove Size | Part Numbers |
|------------|------------------|
| XS | RHI-UNB5XS100BX1 |
| S | RHI-UNB5S100BX1 |
| XL | RHI-UNB5XL100BX1 |
## V. Intended Use/Indications for Use:
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Periwinkle Color 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 | Concentration | Minimum Breakthrough<br>Detection Time |
|-----------------------------|-------------------------|----------------------------------------|
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 14.2 |
| 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) | 43.2 |
| Fentanyl Tested as Follows: | | |
| Fentanyl Citrate Injection | (100 mcg/2mL) | > 240 |
## Test Results Follow:
Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
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# VI. Comparison of Technological Characteristics with Predicate Device
| Characteristic | Standard | Subject Device<br>K223859 | Predicate Device<br>K221082 | Comparison |
|----------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Name &<br>Model: | | Non-sterile, Powder-Free<br>Nitrile Exam Glove<br>Model: RHI-UNB5 | Non-sterile, Powder-Free<br>Nitrile Exam Glove<br>Model: RHI-UNB5 | Identical |
| 510(k) Number: | | K223859 | K221082 | Different |
| Product Codes: | | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, 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 |
| Intended Use: | N/A | This device is a non-sterile<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | This device is a non-sterile<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | Identical |
| Indications for Use: | N/A | Rhino Non-Sterile Powder-<br>Free Nitrile Exam Gloves –<br>Periwinkle Color Tested<br>for Use with<br>Chemotherapy Drugs and<br>Fentanyl is non-sterile<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. The<br>tested chemotherapy drugs<br>are as follows:<br><br>Carmustine (BCNU)<br>(3.3mg/mL 3,300 ppm)<br>14.2<br>Cisplatin (1.0 mg/mL<br>1,000 ppm) > 240<br>Cyclophosphamide<br>(Cytoxan) (20 mg/mL<br>20,000 ppm) > 240<br>Dacarbazine (10 mg/mL<br>10,000 ppm) > 240<br>Doxorubicin<br>Hydrochloride (2.0 mg/mL<br>2,000 ppm) > 240<br>Etoposide (Toposar) (20.0 | Rhino Non-Sterile<br>Powder-Free Nitrile Exam<br>Gloves - Periwinkle Color<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl is non-sterile<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. The<br>tested chemotherapy drugs<br>are as follows:<br><br>Carmustine (BCNU)<br>(3.3mg/mL 3,300 ppm)<br>14.2<br>Cisplatin (1.0 mg/mL<br>1,000 ppm) > 240<br>Cyclophosphamide<br>(Cytoxan) (20 mg/mL<br>20,000 ppm) > 240<br>Dacarbazine (10 mg/mL<br>10,000 ppm) > 240<br>Doxorubicin<br>Hydrochloride (2.0<br>mg/mL 2,000 ppm) > 240<br>Etoposide (Toposar) (20.0 | Identical |
| | | mg/mL 20,000 ppm) > 240 | mg/mL 20,000 ppm) > 240 | |
| | | Flurouracil (50.0 mg/mL<br>50,000 ppm) > 240<br>Paclitaxel (Taxol) (6.0<br>mg/mL 6,000 ppm) > 240<br>Thiotepa(10.0 mg/mL<br>10,000 ppm) 43.2<br>Fentanyl Tested as<br>Follows:<br>Fentanyl Citrate Injection<br>(100 mcg/2mL) > 240<br>Note: Carmustine and<br>Thiotepa have extremely<br>low permeation times of<br>14.2 and 43.2 minutes<br>respectively.<br>Warning: Do Not Use with<br>Carmustine, Thiotepa | 240<br>Flurouracil (50.0 mg/mL<br>50,000 ppm) > 240<br>Paclitaxel (Taxol) (6.0<br>mg/mL 6,000 ppm) > 240<br>Thiotepa(10.0 mg/mL<br>10,000 ppm) 43.2<br>Fentanyl Tested as<br>Follows:<br>Fentanyl Citrate Injection<br>(100 mcg/2mL) > 240<br>Note: Carmustine and<br>Thiotepa have extremely<br>low permeation times of<br>14.2 and 43.2 minutes<br>respectively.<br>Warning: Do Not Use<br>with Carmustine, Thiotepa | |
| Caution/Warning | N/A | WARNING – Not for | WARNING – Not for | Identical |
| Statements: | | use with Carmustine | use with Carmustine | |
| | | and Thiotepa | and Thiotepa | |
| | | | | |
| Dimensions: Overall | ASTM D6319 | X-Small: 239 mm | X-Small: N/A | |
| Length: | Minimum: | Small: 235 mm | Small: N/A | Similar |
| | XS: 220 mm | Medium: N/A | Large: 235 mm | |
| | S: 220 mm | Large: N/A | Medium: 230 mm | |
| | | X-Large: 237 mm | X-Large: N/A | |
| Dimensions: Palm | XL: 230 mm<br>ASTM D6319 | | | |
| Width (mm): | Minimum: | | | |
| | XS: 70 ± 10 | | | |
| | S: 80 ± 10 | XS: 80 | XS: N/A | Similar |
| | M: 95 ± 10 | S: 85 | S: N/A | |
| | L: 110 ± 10 | M: N/A<br>L: N/A | M: 90 - 100<br>L: 103 - 113 | |
| | XL: 120 ± 10 | XL: 112 | XL: N/A | |
| | | | | |
| Dimensions: Palm &<br>Finger Thickness | ASTM D6319<br>Minimum | XS: | | |
| (mm): | Palm: 0.05 | Palm: 0.07 mm | XS: N/A | Similar |
| | Finger: 0.05 | Finger: 0.11 mm | S: N/A | |
| | | Small: | Medium:<br>Palm: 0.07 mm | |
| | | Palm: 0.06 mm | Finger: 0.10 mm | |
| | | Finger: 0.11 mm | Large: | |
| | | M: N/A | Palm: 0.07 mm | |
| | | L: N/A<br>XL: | Finger: 0.10 mm | |
| | | Palm: 0.07 mm | XL: N/A | |
| | | Finger: 0.11 mm | | |
| | | | | |
| Tensile strength: | ASTM D6319 | XS: | XS: N/A | |
| Before & After aging: | Min. Before: | Before: 35.9 MPa | S: N/A | Similar |
| | 14MPa After: | After: 38.7 MPa | Medium: | |
| | 14MPa | S: | Before: 40.9 MPa…
