(286 days)
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.
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.
This document describes the performance of a medical glove, not an AI device. Therefore, several requested categories are not applicable. Here's a breakdown of the requested information based on the provided text, focusing on the glove's performance:
1. Table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Freedom from holes | AQL 2.5: 8 rejection level | Medium: 0 leakers in 50 Large: 1 leaker in 50 (within acceptance limits) 2 leakers in 100 (within acceptance limits) |
| ASTM D6319 | Powder-free | Maximum <2mg/glove | Medium: 0.1 mg Large: 0.4 mg |
| ASTM D6319 | Ultimate elongation before and after aging | Minimum Before Aging: 500% After Aging: 400% | Medium: 563% Large: 555% (Before aging) Medium: 528% Large: 500% (After aging) |
| ASTM D6319 | Tensile Strength before and after aging | Minimum Before: 14 MPa After: 14 MPa | Medium: 44 MPa Large: 38 MPa (Values provided are for before aging, but implicitly after aging also met criteria as typical for such tests) |
| ASTM D6319 | Palm and Finger Thickness | Minimum: Palm: 0.05 mm Finger: 0.05 mm | Medium: 0.09 mm (Palm & Finger not specified separately for Medium) Large: 0.08 mm (Palm & Finger not specified separately for Large) - Assuming these values apply to both palm and finger, they meet the minimum |
| ASTM D6319 | Palm Width | Minimum Medium: 95 mm ± 10 Large: 110 mm ± 10 | Medium: 93 mm (within 95 ± 10 range) Large: 106 mm (within 110 ± 10 range) |
| ASTM D6319 | Length | Minimum: 230 mm | Medium: 236 mm Large: 243 mm |
| ASTM D6978 | Resistance to Permeation by Chemotherapy Drugs | Permeation time (Minutes): Carmustine (BCNU): > 240 Cisplatin: > 240 Cyclophosphamide (Cytoxan): > 240 Dacarbazine: > 240 Doxorubicin Hydrochloride: > 240 Etoposide (Toposar): > 240 Flurouracil: > 240 Paclitaxel (Taxol): > 240 Thiotepa: > 240 Fentanyl Citrate Injection: > 240 | Permeation time (Minutes): Carmustine (BCNU): 23.1 (Does not meet acceptance criteria of >240, hence the warning) Cisplatin: > 240 Cyclophosphamide (Cytoxan): > 240 Dacarbazine: > 240 Doxorubicin Hydrochloride: > 240 Etoposide (Toposar): > 240 Flurouracil: > 240 Paclitaxel (Taxol): > 240 Thiotepa: 24.9 (Does not meet acceptance criteria of >240, hence the warning) Fentanyl Citrate Injection: > 240 |
| ISO 10993-11 Systemic Toxicity Test | Determine potential toxic effects of test article extract | 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 did not induce a significantly greater biological reaction than the control extracts...meets the requirements of the ISO 10993-11 guidelines. |
| ISO 10993-10 Primary Skin Irritation on Rabbits | Determine potential irritation effects of test article extract | 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. (Difference is 0, meets criteria) |
| ISO 10993-10 Guinea Pig Sensitization | Determine potential allergenic or sensitizing capacity | A sensitizer is a test article with which a positive response is observed in at least 10% of the test animals. | 0% sensitization observed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Physical Tests (ASTM D6319):
- Freedom from holes: 50 gloves for Medium size, 50 and 100 gloves for Large size. (Implies multiple samples were taken and tested to demonstrate this AQL).
- Specific sample sizes for other D6319 tests (Ultimate elongation, Tensile strength, Thickness, Palm Width, Length, Powder-Free) are not explicitly stated by number, but assumed to be sufficient for ASTM standard compliance, likely involving multiple gloves per size.
- Sample Size for Chemotherapy Permeation (ASTM D6978): Not explicitly stated, but per ASTM D6978, at least three specimens (gloves) should be tested for breakthrough time for each chemical.
- Sample Size for Biocompatibility (ISO 10993-10, ISO 10993-11):
- ISO 10993-11 Systemic Toxicity: "Albino Swiss mice" (number not specified, but typically multiple mice per extract and control group).
- ISO 10993-10 Primary Skin Irritation: "New Zealand white rabbits" (number not specified, but typically multiple rabbits).
- ISO 10993-10 Guinea Pig Sensitization: "test animals" (number not specified, but typically multiple guinea pigs).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Non-clinical testing typically involves prospective laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a non-clinical performance evaluation of a physical device against established ASTM and ISO standards, not an AI device requiring human expert ground truth for interpretation. The "ground truth" here is the measurement against the specified standard criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical performance evaluation against standardized laboratory tests; there is no human interpretation or adjudication in the sense of comparing opinions. The results are quantitative measurements against objective criteria specified by the standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to a medical glove, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a medical glove, not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is defined by adherence to established international and national standards for medical gloves and testing protocols:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6978-05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-11: Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity
- ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
These standards specify the methodologies, acceptance/rejection criteria, and measurement techniques. The "ground truth" is therefore derived from the objective measurements obtained through these standardized tests.
8. The sample size for the training set
Not applicable. This document pertains to non-clinical testing of a physical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a medical device that is not AI/ML based.
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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 (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
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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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 66Church 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 forUse 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 | ApprovalDate |
|---|---|---|---|
| Sri Trang Gloves(Thailand) PublicCompanyLimited | Non-Sterile, Powder Free Nitrile Exam Glove Testedfor use with Chemotherapy Drugs - Lilac, Non-Sterile,Powder Free Nitrile Exam Glove Tested for use withChemotherapy Drugs - Orchid, Non-Sterile, PowderFree Nitrile Exam Glove Tested for use withChemotherapy Drugs - Oyster | K193581 | March 20,2020 |
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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 BreakthroughDetection 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 DeviceK193581 | Remark |
|---|---|---|---|---|
| Device Name &Model: | Non-sterile, Powder-FreeNitrile Exam GloveModel: RH001 | Non-sterile, Powder- FreeNitrile 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 withChemotherapy Drugs andFentanyl is non-steriledisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examinerChemotherapy Drug'sConcentration at MinimumBreakthrough Detection Time:Carmustine(BCNU)(3.3mg/mL 3,300ppm) 23.1Cisplatin (1.0 mg/mL 1,000ppm) > 240Cyclophosphamide (Cytoxan)(20 mg/mL 20,000 ppm) >240Dacarbazine (10 mg/mL10,000 ppm) > 240Doxorubicin Hydrochloride(2.0 mg/mL 2,000 ppm) > 240Etoposide (Toposar) (20.0mg/mL 20,000 ppm) > 240Flurouracil (50.0 mg/mL50,000 ppm) > 240Paclitaxel (Taxol) (6.0 mg/mL6,000 ppm) > 240Thiotepa (10.0 mg/mL 10,000ppm) 24.9Fentanyl Tested asFollows:Fentanyl CitrateInjection (100 mcg/2mL)> | This device is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner.Bleomycin Sulfate 15 mg/mL,>240 minutesBusulfan 6 mg/mL, >240minutesCarboplatin (Paraplatin) 10mg/mL, >240 minutesCarmustine (BCNU) 3.3mg/mL, 17.1 minutesCisplatin 1.0 mg/mL, >240minutesCyclophosphamide (Cytoxan)20 mg/mL, >240 minutesCytarabine 100 mg/mL, >240minutesDacarbazine (DTIC) IOmg/mL, >240 minutesDaunorubicin 5 mg/mL, >240minutesDocetaxel IO mg/mL, >240minutesDoxorubicin Hydrochloride 2mg/mL, >240 minutesEpirubicin (Ellence) 2mg/mL, >240 minutesEtoposide (Toposar) 20mg/mL, >240 minutesFludarabine 25 mg/mL, >240minutesFluorouracil 50 mg/mL, >240minutes | Similar |
| Caution/WarningStatements: | N/A | WARNING – Not foruse with Carmustineand Thiotepa | WARNING – Notfor use with Carmustine andThiotepa | Identical |
| Dimensions: OverallLength: | ASTM D6319 | Minimum: 230 mmLarge: 237 mm | 238 mm | Similar |
| Dimensions: PalmWidth (mm): | ASTM D6319Minimum:XS: 70 ± 10S: 80 ± 10M: 95 ± 10L: 110 ± 10XL: 120 ± 10 | M: 90 – 100L: 103 – 113N/A | N/AN/A110N/A | Similar |
| Dimensions: Palm &Finger Thickness(mm): | ASTM D6319MinimumPalm: 0.05Finger: 0.05 | Large:Palm: 0.08 mmFinger: 0.12 mm | Palm: 0.05 mmFinger: 0.08 mm | Similar |
| Tensile strength:Before & After aging: | ASTM D6319Min.Before: 14MPaAfter: 14Mpa | Large:Before: 36.8 MPaAfter: 39.1 MPa | Before: 34 MPaAfter: 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 D6319G1, AQL 2.57 Accept8 Reject | Medium: No leakers in 50Large: 1 leaker in 502 leakers in 100 | Pass | Identical |
| Powder-Free | ASTM D6319Maximum<2mg/glove | PassMedium: 0.1 mgLarge: 0.4 mg | Pass | Identical |
| Biocompatibility | ISO 10993-11SystemicToxicityTest | Under the conditions of thestudy, the extracts of the testarticle did not induce asignificantly greaterbiological reaction then thecontrol extracts. Based on thecriteria of the protocol, thetest article meets therequirements of the ISO10993-11 guidelines. | The device extracts did notelicit a systemic response inthe animal model. | Similar |
| ISO 10993-10PrimarySkinIrritation onRabbits | Under the conditions of thestudy, the test article sitesdid not show a significantlygreater biological reactionthan the sites injected withthe control article. The testarticle meets therequirements of ISO 10993-10 guidelines. | Under the conditions of thestudy, the polar and non-polardevice extracts were found notto be an irritant to the animalmodel | Similar | |
| ISO 10993-10Guinea PigSensitization | Under the conditions of thestudy, the extracts of thedevice elicited no reaction.Therefore, as defined b thegrading scale of the USP, thetest article is classified as anon-sensitizer. The testarticle meets therequirements of ISO 10993- | Under the conditions of thestudy, the polar and non-polardevice extracts were found notto be sensitizers to the animalmodel. | 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:
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Freedom fromholes | AQL 2.5: 8 rejection level | Medium: 0 leakers in 50Large: 1 leaker in 502 leakers in 100 |
| ASTM D6319 | Powder-free | Maximum <2mg/glove | Medium: 0.1 mgLarge: 0.4 mg |
| ASTM D6319 | Ultimateelongationbefore andafter aging | MinimumBefore Aging: 500%After Aging: 400% | Medium: 563%Large: 555%Medium: 528%Large: 500% |
| ASTM D6319 | TensileStrengthbefore andafter aging | MinimumBefore: 14 MPaAfter: 14 MPa | Medium: 44 MPaLarge: 38 MPa |
| ASTM D6319 | Palm andFingerThickness | Minimum:Palm: 0.05 mmFinger: 0.05 mm | Medium: 0.09 mmLarge: 0.08 mm |
| ASTM D6319 | Palm Width | MinimumMedium: 95 mm ± 10Large: 110 mm ± 10 | Medium: 93 mmLarge: 106 mm |
| ASTM D6319 | Length | Minimum:230 mm | Medium: 236 mmLarge: 243 mm |
| ASTM D6978 | Resistance toPermeation byChemotherapyDrugs | Permeation time(Minutes):Carmustine (BCNU)(3.3mg/mL 3,300 ppm) >240Cisplatin (1.0 mg/mL1,000 ppm) > 240Cyclophosphamide(Cytoxan) (20 mg/mL20,000 ppm) > 240Dacarbazine (10mg/mL10,000 ppm) > 240DoxorubicinHydrochloride (2.0mg/mL 2,000 ppm) > 240Etoposide (Toposar) (20.0mg/mL 20,000 ppm) >240Flurouracil (50.0 mg/mL50,000 ppm) > 240Paclitaxel (Taxol) (6.0mg/mL 6,000 ppm) > 240 | Permeation time (Minutes):Carmustine (BCNU) (3.3mg/mL3,300 ppm), 23.1Cisplatin (1.0 mg/mL 1,000ppm)> 240Cyclophosphamide (Cytoxan) (20mg/mL20,000 ppm) > 240Dacarbazine (10 mg/mL10,000 ppm) > 240Doxorubicin Hydrochloride (2.0mg/mL 2,000 ppm) >240Etoposide (Toposar) (20.0mg/mL20,000 ppm) > 240Flurouracil (50.0 mg/mL 50,000ppm) > 240Paclitaxel (Taxol) (6.0mg/mL 6,000 ppm)> 240Thiotepa (10.0 mg/mL 10,000ppm) 24.9 |
| Thiotepa (10.0 mg/mL10,000 ppm) > 240Fentanyl Citrate Injection(100 mcg/2mL) > 240 | Fentanyl Citrate Injection (100mcg/2mL) > 240 | ||
| ISO 10993-11SystemicToxicity Test | Determine thepotential toxiceffects of thetest articleextract as aresult of asingle-dosesystemicinjection inmice. | Test passes if none of theanimals injected show asignificantly greaterbiological reaction thanthe animals treated withthe control article. | The USP 0.9% Sodium Chloridefor Injection and Cottonseed Oilextracts of the test article, RHUSANitrile glove, did not induce asignificantly greater biologicalreaction than the control extractsfollowing a single dose to AlbinoSwiss mice. Based on the criteria ofthe protocol, the test article meetsthe requirements of the ISO 10993-11 guidelines. |
| ISO 10993-10Primary SkinIrritation onRabbits | Determine thepotentialirritationeffects of thetest articleextract as aresult of anintracutaneousinjection inNew Zealandwhite rabbits | The requirements of thetest are met if thedifference between the testarticle mean score and thevehicle control mean scoreis 1.0 or less. | The over mean score of the testarticle was 0.4 and the overall meanscore of the vehicle control was 0.4. |
| ISO 10993-10Guinea PigSensitization | Determine thepotentialallergenic orsensitizingcapacity of thetest article | A sensitizer is a testarticle with which apositive response isobserved in at least 10%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; 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
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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.
§ 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.