(231 days)
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
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 |
The provided text is a 510(k) Summary for a medical device: "Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the extensive clinical study data one would find for novel, higher-risk devices. As such, the information you're requesting regarding AI-specific criteria, human expert adjudication, and large-scale training/test data for an AI algorithm is largely not applicable to this document because it describes a physical examination glove, not an AI/ML medical device.
However, I will extract and present the available information related to acceptance criteria and the "study" (non-clinical testing) that proves the device meets them, while also clearly indicating what information is not present or applicable.
Acceptance Criteria and Device Performance (Non-Clinical)
The acceptance criteria for this medical glove are based on established ASTM and ISO standards for physical properties, barrier integrity, and biocompatibility, as well as an assessment for chemical permeation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported performance are derived from Section VI of the 510(k) Summary: "Comparison of Technological Characteristics with Predicate Device" and Section VII: "Non-Clinical Studies."
| Characteristic / Test Method | Acceptance Criteria | Reported Device Performance (Subject Device K221082) | Basis for Acceptance (Standard) |
|---|---|---|---|
| Material/Use | |||
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Similar to Predicate |
| Prescription or OTC | OTC (Over-The-Counter) | OTC | Similar to Predicate |
| Single-use Disposable | Yes | Yes | Similar to Predicate |
| Physical Dimensions | |||
| Overall Length | Minimum: 230 mm (ASTM D6319) | Large: 235 mm; Medium: 230 mm | ASTM D6319 |
| Palm Width | XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10 (ASTM D6319) | Medium: 90-100 mm; Large: 103-113 mm | ASTM D6319 |
| Palm Thickness | Minimum: 0.05 mm (ASTM D6319) | Large: 0.07 mm; Medium: 0.07 mm | ASTM D6319 |
| Finger Thickness | Minimum: 0.05 mm (ASTM D6319) | Large: 0.10 mm; Medium: 0.10 mm | ASTM D6319 |
| Physical Properties | |||
| Tensile Strength (Before Aging) | Minimum: 14 MPa (ASTM D6319) | Large: 33.4 MPa; Medium: 40.9 MPa | ASTM D6319 |
| Tensile Strength (After Aging) | Minimum: 14 MPa (ASTM D6319) | Large: 39.0 MPa; Medium: 35.5 MPa | ASTM D6319 |
| Ultimate Elongation (Before Aging) | Minimum: 500% (ASTM D6319) | Large: 520%; Medium: 550% | ASTM D6319 |
| Ultimate Elongation (After Aging) | Minimum: 400% (ASTM D6319) | Large: 520%; Medium: 510% | ASTM D6319 |
| Freedom from Holes | G1, AQL 2.5 (ASTM D6319) | Medium: 2 leakers in 50, 3 leakers in 100; Large: 4 leakers in 50, 4 leakers in 100, 4 leakers in 150. All "Pass". | ASTM D6319, ASTM D5151 |
| Powder-Free (Powder Residue) | < 2.0 mg/glove (ASTM D6319) | Medium: 0.9 mg; Large: 0.6 mg. All "Pass". | ASTM D6319, ASTM D6124 |
| Biocompatibility | |||
| Acute Systemic Toxicity | Non-acute systemic toxicity; no animals treated with test extracts exhibit greater reaction than control animals. (ISO 10993-11) | Under conditions of study, did not show acute systemic toxicity in vivo/Pass. | ISO 10993-11 |
| Primary Skin Irritation | Non-irritating; Primary irritation Index $\le$ 1.0 (ISO 10993-10) | Under conditions of study, not an irritant/Pass. | ISO 10993-10 |
| Guinea Pig Sensitization | Non-sensitizing; Grade < 1 (ISO 10993-10) | Under conditions of study, not a sensitizer/Pass. | ISO 10993-10 |
| Chemotherapy Drug Permeation | |||
| Fentanyl Citrate Injection (100 mcg/2mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Cisplatin (1.0 mg/mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Cyclophosphamide (20 mg/mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Dacarbazine (10 mg/mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Doxorubicin HCl (2.0 mg/mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Etoposide (20.0 mg/mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Flurouracil (50.0 mg/mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Paclitaxel (6.0 mg/mL) | Minimum Breakthrough Detection Time > 240 min (ASTM D6978-05) | > 240 minutes | ASTM D6978-05 |
| Carmustine (3.3mg/mL) | No explicit "acceptance criteria" beyond general permeation assessment, but breakthrough time given. | 14.2 minutes (Noted as "extremely low permeation time" and "Do Not Use with Carmustine") | ASTM D6978-05; Warning/Labeling |
| Thiotepa (10.0 mg/mL) | No explicit "acceptance criteria" beyond general permeation assessment, but breakthrough time given. | 43.2 minutes (Noted as "extremely low permeation time" and "Do Not Use with Thiotepa") | ASTM D6978-05; Warning/Labeling |
Note on Chemotherapy Permeation: For most chemotherapy drugs, the acceptance criteria are implicitly met by achieving a breakthrough detection time of >240 minutes. For Carmustine and Thiotepa, while permeation times are reported, the device is explicitly warned against use with these drugs, meaning the acceptance criterion for safe use with these specific drugs is effectively "not intended."
Information Not Applicable or Not Provided
The request is tailored for AI/ML device studies. This submission is for a physical medical glove. Therefore, most of the requested points are not applicable or the information is not provided in the 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Specific sample sizes for each physical test (e.g., how many gloves for tensile strength, or how many for hole detection) are not explicitly detailed beyond the general "Pass" results against AQLs (Acceptable Quality Levels) or ASTM minimums. For permeation tests, breakthrough times are given for specific (presumably triplicate or similar standardized) specimens as per ASTM D6978-05.
- Data Provenance: Not specified, but standard testing for medical devices typically occurs in specialized labs following good laboratory practices (GLP). It would be considered prospective testing for the purpose of this submission.
- Retrospective or Prospective: The testing reported is prospective, specifically performed to demonstrate conformance to standards for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" (i.e., whether the glove meets specifications) is established through standardized laboratory testing protocols, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3. Testing is based on objective measurements against engineering and material 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 is not an AI-driven device. No human-in-the-loop studies or MRMC studies were conducted as part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical/Chemical Standards Compliance: The "ground truth" is compliance with established international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993-10, ISO 10993-11) verified through laboratory testing.
8. The sample size for the training set:
- Not Applicable. There is no AI model or training set for this product.
9. How the ground truth for the training set was established:
- Not Applicable. There is no AI model or training set for this product.
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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.
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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 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
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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)
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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 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 – Periwinkle ColorTested 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 |
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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 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
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VI. Comparison of Technological Characteristics with Predicate Device
| Characteristic | Standard | Subject DeviceK221082 | Predicate DeviceK203236 | Comparison |
|---|---|---|---|---|
| Device Name &Model: | Non-sterile, Powder-FreeNitrile Exam GloveModel: RHI-UNB5 | Non-sterile, Powder-FreeNitrile Exam GloveModel: 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-steriledisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | This device is a non-steriledisposable device intendedfor medical purposes thatis worn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | Identical |
| Indications for Use(summary): | N/A | Rhino Non-Sterile Powder-Free Nitrile Exam Gloves -Periwinkle Color Testedfor Use withChemotherapy Drugs andFentanyl is non-steriledisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thetested chemotherapy drugsare as follows:Carmustine (BCNU)(3.3mg/mL 3,300 ppm)14.2Cisplatin (1.0 mg/mL1,000 ppm) > 240Cyclophosphamide(Cytoxan) (20 mg/mL20,000 ppm) > 240Dacarbazine (10 mg/mL10,000 ppm) > 240DoxorubicinHydrochloride (2.0 mg/mL2,000 ppm) > 240Etoposide (Toposar) (20.0mg/mL 20,000 ppm) > 240Flurouracil (50.0 mg/mL | Rhino Non-SterilePowder-Free Nitrile ExamGloves – Blue Tested forUse with ChemotherapyDrugs and Fentanyl isnon-sterile disposabledevice intended formedical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thetested chemotherapy drugsare as follows:Carmustine (BCNU)(3.3mg/mL 3,300 ppm)23.1Cisplatin (1.0 mg/mL1,000 ppm) > 240Cyclophosphamide(Cytoxan) (20 mg/mL20,000 ppm) > 240Dacarbazine (10 mg/mL10,000 ppm) > 240DoxorubicinHydrochloride (2.0mg/mL 2,000 ppm) > 240Etoposide (Toposar) (20.0mg/mL 20,000 ppm) >240 | Similar |
| Paclitaxel (Taxol) (6.0mg/mL 6,000 ppm) > 240Thiotepa (10.0 mg/mL10,000 ppm) 43.2Fentanyl Tested asFollows:Fentanyl Citrate Injection(100 mcg/2mL) > 240Note: Carmustine andThiotepa have extremelylow permeation times of14.2 and 43.2 minutesrespectively.Warning: Do Not Use withCarmustine, Thiotepa | 50,000 ppm) > 240Paclitaxel (Taxol) (6.0mg/mL 6,000 ppm) > 240Thiotepa (10.0 mg/mL10,000 ppm) 24.9Fentanyl Tested asFollows:Fentanyl Citrate Injection(100 mcg/2mL) > 240Note: Carmustine andThiotepa have extremelylow permeation times of23.1 and 24.9 minutesrespectively.Warning: Do Not Usewith Carmustine, Thiotepa | |||
| Caution/WarningStatements: | N/A | WARNING – Not foruse with Carmustineand Thiotepa | WARNING – Not foruse with Carmustineand Thiotepa | Identical |
| Dimensions: OverallLength: | ASTM D6319Minimum:230 mm | Large: 235 mmMedium: 230 mm | Large: 237 mmMedium: 235 mm | Similar |
| Dimensions: PalmWidth (mm): | ASTM D6319Minimum:XS: 70 ± 10S: 80 ± 10M: 95 ± 10L: 110 ± 10XL: 120 ± 10 | N/AN/A90 — 100103 - 113N/A | N/AN/A90 — 100103 - 113N/A | Similar |
| Dimensions: Palm &Finger Thickness(mm): | ASTM D6319MinimumPalm: 0.05Finger: 0.05 | Large:Palm: 0.07 mmFinger: 0.10 mmMedium:Palm: 0.07 mmFinger: 0.10 mm | Large:Palm: 0.08 mmFinger: 0.12 mmMedium:Palm: 0.08 mmFinger: 0.11 mm | Similar |
| Tensile strength:Before & After aging: | ASTM D6319Min. Before:14MPa After:14Mpa | Large:Before: 33.4 MPaAfter: 39.0 MPaMedium:Before: 40.9 MPaAfter: 35.5 MPa | Large:Before: 36.8 MPaAfter: 39.1 MPaMedium:Before: 39.8 MPaAfter: 41.8 MPa | Similar |
| Ultimate elongationBefore & After aging: | ASTM D6319Minimum: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 D6319G1, AQL 2.5 | PassMedium: 2 leakers in 503 leakers in 100Large: 4 leakers in 504 leakers in 1004 leakers in 150 | PassMedium: No leakers in 50Large: 1 leaker in 502 leakers in 100 | Similar |
| Powder-Free | ASTM D6319Maximum<2mg/glove | PassMedium: 0.9 mgLarge: 0.6 mg | PassMedium: 0.1 mgLarge: 0.4 mg | Similar |
| Biocompatibility | ISO 10993-11AcuteSystemicToxicity Test | Under the conditions of thestudy, the extracts of thetest article did not induce asignificantly greaterbiological reaction than thecontrol extracts. Based onthe criteria of the protocol,the test article meets therequirements of the ISO10993-11 guidelines. | Under the conditions ofthe study, the extracts ofthe test article did notinduce a significantlygreater biological reactionthan the control extracts.Based on the criteria of theprotocol, the test articlemeets the requirements ofthe ISO 10993-11guidelines. | Similar |
| ISO 10993-10Primary SkinIrritation onRabbits | Under the conditions of thestudy, the test article sitesdid not show asignificantly greaterbiological reaction than thesites injected with thecontrol article. The testmeets the requirements ofISO 10993-10 guidelines. | Under the conditions ofthe study, the test articlesites did not show asignificantly greaterbiological reaction thanthe sites injected with thecontrol article. The testarticle meets therequirements of ISO10993-10 guidelines. | Similar | |
| ISO 10993-10Guinea PigSensitization | Under the conditions of thestudy, the extracts of thedevice elicited no reaction.Therefore, as defined bythe grading scale of theUSP, the test article isclassified as a non-sensitizer. The test articlemeets the requirements ofISO 10993-10 guidelines. | Under the conditions ofthe study, the extracts ofthe device elicited noreaction. Therefore, asdefined by the gradingscale of the USP, the testarticle is classified as anon-sensitizer. The testarticle meets therequirements of ISO10993-10 guidelines. | Similar | |
| TestMethodology | Purpose | Acceptance Criteria | Results | |
| ASTM D6319 | PhysicalDimensions Test | Medium:Length: $\ge$ 230 mmWidth: 95 ± 10 mmLarge:Length: $\ge$ 230 mmWidth: 110 ± 10 mm | Pass | |
| Thickness:Finger: $\ge$ 0.05Palm: $\ge$ 0.05 | Pass | |||
| PhysicalProperties | Before AgingTensile Strength $\ge$ 14 MPaUltimate Elongation $\ge$ 500% | Pass | ||
| After AgingTensile Strength $\ge$ 14 MPaUltimate Elongation $\ge$ 400% | Pass | |||
| ASTM D5151 | Freedom fromholes | Meet the requirements of ASTMD5151 for AQL 2.5 | Pass | |
| ASTM D6124 | Powder Residue | < 2.0 mg | Pass | |
| ISO 10993-10 | To determine ifthe finisheddevice materialis an irritant | Non-irritating; Primary irritationIndex $\le$ 1.0 | Under theconditions of thestudy, not anirritant/Pass | |
| ISO 10993-10 | To determine ifthe finisheddevice materialis a sensitizer | Non-sensitizing; Grade < 1 | Under theconditions of thestudy, not asensitizer/Pass | |
| ISO 10993-11 | To determine ifthe finisheddevice materialextracts pose asystemictoxicity concern | Non-acute systemic toxicity, noanimals treated with test extractsexhibit greater reaction than controlanimals. | Under theconditions of thestudy, did notshow acutesystemictoxicity invivo/Pass | |
| ASTM D6978-05 | To determine | The test determines what the | All drugs |
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RHINO HEALTH, INC. Section 6. 510(k) Summary
Both devices pass all non-clinical studies done on both devices are identical. The differences between the Subject Device and Predicate Device do not raise any concerns. The differences include (1) the results of permeation test for Carmustine and Thiotepa; and (2) the results of the various physical tests. Neither device had permeation of > 240 minutes for Carmustine and Thiotepa, however the permeation rate for each was difference does not affect the device since both are labeled as "Not for use with Carmustine and Thiotepa." The results of the physical tests were different for the Predicate Device and Subject Device, however all results passed in accordance with ASTM D6124, and ASTM D5151.
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VII. Non-Clinical Studies
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
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| permeation rateof specificchemotherapydrugs | permeation of a particular drug is andtherefore there is no “acceptancecriteria” beyond a minimumbreakthrough detection time of >240min on all three (3) specimens. | exceptCarmustine andThiotepa, hadpermeation timeof > 20 minutes.Carmustinepermeation timewas 14.2minutes andThiotepapermeation timewas 43.2minutes |
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| --------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- ASTM D6319-19. Standard Specification for Nitrile Examination Gloves for Medical ● Application
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical Gloves ●
- ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of Medical ● Gloves to Permeation by Chemotherapy Drugs
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices Part11:Tests for Systemic ● Toxicity
VIII. Clinical Studies
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Subject Device 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.