(231 days)
Not Found
No
The device is a physical exam glove and the description focuses on its material properties and performance against chemical permeation, with no mention of software, data processing, or AI/ML technologies.
No
The device is described as a non-sterile disposable glove intended for medical purposes to prevent contamination, not to provide therapy or treatment.
No.
The device is a non-sterile disposable glove intended for medical purposes to prevent contamination between a patient and an examiner, not to diagnose a condition.
No
The device description clearly states it is a physical glove, a non-sterile disposable device worn on the hand or finger. It also details physical characteristics like size and color, and performance testing related to material properties and chemical resistance, which are all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as 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 describes a barrier device used for personal protection and infection control during patient contact.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device description further reinforces that it is a glove worn on the hand.
- Performance Studies: The performance studies listed (ASTM and ISO standards) relate to the physical properties and barrier performance of the glove, not to the analysis of biological specimens.
The testing for chemotherapy drugs and fentanyl is related to the glove's ability to provide a barrier against these substances, which is a safety feature for the user, not a diagnostic function.
Therefore, this device falls under the category of a medical device used for personal protection and infection control, not an In Vitro Diagnostic device.
N/A
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. 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
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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
Test results were provided for:
- Physical Dimensions Test (ASTM D6319) - Pass
- Physical Properties (ASTM D6319) - Pass
- Freedom from holes (ASTM D5151) - Pass
- Powder Residue (ASTM D6124) - Pass
- Biocompatibility (ISO 10993-10, ISO 10993-11) - Non-irritating, Non-sensitizing, Non-acute systemic toxicity. Pass.
- Permeation rate of specific chemotherapy drugs (ASTM D6978-05) - All drugs except Carmustine and Thiotepa, had permeation time of > 20 minutes. Carmustine permeation time was 14.2 minutes and Thiotepa permeation time was 43.2 minutes.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See summary of performance studies for specific physical and chemical test results in comparison with the predicate device.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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
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.
8
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:
9
| permeation rate
of specific
chemotherapy
drugs | permeation of a particular drug is and
therefore there is no “acceptance
criteria” beyond a minimum
breakthrough detection time of >240
min on all three (3) specimens. | except
Carmustine and
Thiotepa, had
permeation time
of > 20 minutes.
Carmustine
permeation time
was 14.2
minutes and
Thiotepa
permeation time
was 43.2
minutes |
| --------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- 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.