Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl

Q: Who is the manufacturer of Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

Rhino Health, Inc. filed the 510(k) submission for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl (K221082).

Q: What is the FDA product code for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K221082 · Rhino Health, Inc. · LZA · Nov 30, 2022 · General Hospital

Device Facts

Record ID	K221082
Device Name	Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
Applicant	Rhino Health, Inc.
Product Code	LZA · General Hospital
Decision Date	Nov 30, 2022
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 clinicians to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and fentanyl per ASTM D6978-05. Not for use with Carmustine or Thiotepa due to low breakthrough detection times. Device provides a physical barrier; does not involve active sensing or software. Used in clinical settings.

Clinical Evidence

No clinical data. Bench testing only, including physical dimensions, tensile strength, elongation, freedom from holes (ASTM D5151), residual powder (ASTM D6124), biocompatibility (ISO 10993-10, ISO 10993-11), and chemotherapy drug permeation (ASTM D6978-05).

Technological Characteristics

Nitrile examination glove; powder-free. Complies with ASTM D6319, ASTM D5151, ASTM D6124, and ASTM D6978-05. Biocompatibility per ISO 10993-10 and ISO 10993-11. Non-sterile. Dimensions: Medium (230mm length, 0.07mm palm thickness), Large (235mm length, 0.07mm palm thickness).

Indications for Use

Indicated for use as a non-sterile, disposable medical 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 – Blue Tested for Use with Chemotherapy Drugs and Fentanyl (K203236)

Related Devices

K223859 — Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl · Rhino Health, Inc. · Feb 13, 2023
K173137 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) · Hartalega Sdn Bhd · Dec 12, 2017
K210730 — Nitrile Patient Examination Glove · American Performance Polymers, LLC · Aug 10, 2021
K160560 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) · Hartalega Sdn Bhd · Aug 4, 2016
K222714 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Oct 7, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 30, 2022 Rhino Health Inc. % Suzan Davis CEO and US Agent Global Regulatory Partners Inc. 550 Cochituate Road. East wing, Floor 4, Suite 25 Framingham, Massachusetts 01701 Re: K221082 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: October 25, 2022 Received: November 2, 2022 Dear Suzan Davis: 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 mediation-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 Qial Bifeng Oian, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221082 #### Device Name Rhino Non-sterile Powder-Free Nitrile Exam Glove - 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) > Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to 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." {3}------------------------------------------------ ## 510(k) Summary ## 510(K): K221082 Date Prepared: November 29, 2022 ## 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 – Periwinkle Color 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 – Blue Tested for Use with Chemotherapy Drugs and Fentanly | K203236 | August 16, 2021 | {4}------------------------------------------------ ## 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 two sizes, medium and 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 | |------------|-----------------| | M | RHI-UNB5M100BX1 | | L | RHI-UNB5L100BX1 | #### 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 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 {5}------------------------------------------------ ## VI. Comparison of Technological Characteristics with Predicate Device | Characteristic | Standard | Subject Device K221082 | Predicate Device K203236 | Comparison | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device Name & Model: | | Non-sterile, Powder-Free Nitrile Exam Glove Model: RHI-UNB5 | Non-sterile, Powder-Free Nitrile Exam Glove Model: RH001 | Similar | | 510(k) Number: | | K221082 | K203236 | Different | | Product Codes: | | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Similar | | 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 disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | This device is 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. | Identical | | Indications for Use (summary): | N/A | 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: 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 | 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: 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 | Similar | | | 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 | 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 Note: Carmustine and Thiotepa have extremely low permeation times of 23.1 and 24.9 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa | | | | 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: 235 mm Medium: 230 mm | Large: 237 mm Medium: 235 mm | Similar | | Dimensions: Palm Width (mm): | ASTM D6319 Minimum: XS: 70 ± 10 S: 80 ± 10 M: 95 ± 10 L: 110 ± 10 XL: 120 ± 10 | N/A N/A 90 — 100 103 - 113 N/A | N/A N/A 90 — 100 103 - 113 N/A | Similar | | Dimensions: Palm & Finger Thickness (mm): | ASTM D6319 Minimum Palm: 0.05 Finger: 0.05 | Large: Palm: 0.07 mm Finger: 0.10 mm Medium: Palm: 0.07 mm Finger: 0.10 mm | Large: Palm: 0.08 mm Finger: 0.12 mm Medium: Palm: 0.08 mm Finger: 0.11 mm | Similar | | Tensile strength: Before & After aging: | ASTM D6319 Min. Before: 14MPa After: 14Mpa | Large: Before: 33.4 MPa After: 39.0 MPa Medium: Before: 40.9 MPa After: 35.5 MPa | Large: Before: 36.8 MPa After: 39.1 MPa Medium: Before: 39.8 MPa After: 41.8 MPa | Similar | | Ultimate elongation Before & After aging: | ASTM D6319 Minimum: Before: 500% After: 400% | Large: Before: 520% After: 520% Medium: Before: 550% After: 510% | Large: Before: 540% After: 490% Medium: Before: 560% After: 510% | Similar | | | | | | | | Freedom from holes: | ASTM D6319 G1, AQL 2.5 | Pass Medium: 2 leakers in 50 3 leakers in 100 Large: 4 leakers in 50 4 leakers in 100 4 leakers in 150 | Pass Medium: No leakers in 50 Large: 1 leaker in 50 2 leakers in 100 | Similar | | Powder-Free | ASTM D6319 Maximum <2mg/glove | Pass Medium: 0.9 mg Large: 0.6 mg | Pass Medium: 0.1 mg Large: 0.4 mg | Similar | | Biocompatibility | ISO 10993-11 Acute Systemic Toxicity Test | Under the conditions of the study, the extracts of the test article did not induce a significantly greater biological reaction than the control extracts. Based on the criteria of the protocol, the test article meets the requirements of the ISO 10993-11 guidelines. | Under the conditions of the study, the extracts of the test article did not induce a significantly greater biological reaction than the control extracts. Based on the criteria of the protocol, the test article meets the requirements of the ISO 10993-11 guidelines. | Similar | | | ISO 10993-10 Primary Skin Irritation on Rabbits | Under the conditions of the study, the test article sites did not show a significantly greater biological reaction than the sites injected with the control article. The test meets the requirements of ISO 10993-10 guidelines. | Under the conditions of the study, the test article sites did not show a significantly greater biological reaction than the sites injected with the control article. The test article meets the requirements of ISO 10993-10 guidelines. | Similar | | | ISO 10993-10 Guinea Pig Sensitization | Under the conditions of the study, the extracts of the device elicited no reaction. Therefore, as defined by the grading scale of the USP, the test article is classified as a non- sensitizer. The test article meets the requirements of ISO 10993-10 guidelines. | Under the conditions of the study, the extracts of the device elicited no reaction. Therefore, as defined by the grading scale of the USP, the test article is classified as a non-sensitizer. The test article meets the requirements of ISO 10993-10 guidelines. | Similar | | Test Methodology | Purpose | Acceptance Criteria | Results | | | ASTM D6319 | Physical Dimensions Test | Medium: Length: $\ge$ 230 mm Width: 95 ± 10 mm Large: Length: $\ge$ 230 mm Width: 110 ± 10 mm | Pass | | | | | Thickness: Finger: $\ge$ 0.05 Palm: $\ge$ 0.05 | Pass | | | | Physical Properties | Before Aging Tensile Strength $\ge$ 14 MPa Ultimate Elongation $\ge$ 500% | Pass | | | | | After Aging Tensile Strength $\ge$ 14 MPa Ultimate Elongation $\ge$ 400% | Pass | | | ASTM D5151 | Freedom from holes | Meet the requirements of ASTM D5151 for AQL 2.5 | Pass | | | ASTM D6124 | Powder Residue | < 2.0 mg | Pass | | | ISO 10993-10 | To determine if the finished device material is an irritant | Non-irritating; Primary irritation Index $\le$ 1.0 | Under the conditions of the study, not an irritant/Pass | | | ISO 10993-10 | To determine if the finished device material is a sensitizer | Non-sensitizing; Grade < 1 | Under the conditions of the study, not a sensitizer/Pass | | | ISO 10993-11 | To determine if the finished device material extracts pose a systemic toxicity concern | Non-acute systemic toxicity, no animals treated with test extracts exhibit greater reaction than control animals. | Under the conditions of the study, did not show acute systemic toxicity in vivo/Pass | | | ASTM D6978-05 | To determine | The test determines what the | All drugs…

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves  Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl