(83 days)
Not Found
No
The device is a physical examination glove and the description focuses on material properties and performance against chemical permeation, with no mention of AI or ML.
No.
The device is an examination glove, intended to prevent contamination between patient and examiner, and is not designed to treat, cure, mitigate, or prevent disease.
No
The device is a non-sterile, disposable examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device described is a physical medical device (examination gloves) and does not involve any software component.
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 disposable device worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and materials of the glove, and its compliance with standards for examination gloves and resistance to chemical permeation.
- Performance Studies and Key Metrics: The performance studies and key metrics are related to the physical integrity, biocompatibility, and chemical resistance of the glove (e.g., tensile strength, elongation, breakthrough time for chemicals). There are no metrics related to diagnosing a condition or analyzing a sample from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a Powder Free Nitrile Examination Glove. The subject device is a patient examination glove manufactured 100% nitrile-Butadiene Copolymer dispersion), Per 21 CFR 880.6250, Product codes LZA, LZC, OPJ, QDO and Class 1, Blue Color, Powder Free and Non-Sterile. The device meets the specifications in ASTM D6319-19. Standard specifications for Nitrile Examination Gloves. The glove sizes provided are Small, Medium, Large, and X-Large. The gloves design features include ambidextrous and textured fingers. The subject device complies with requirements for standard practice for assessment of resistance of medical glove to permeation by chemotherapy drugs as per ASTM D6978-05 (2019).
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 (i.e., medical professionals)
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 test were conducted to verify that the proposed device met all design specifications.
Biocompatibility Testing:
- ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity. Results: Was considered Cytotoxic (Predicate: Under the conditions of the study, cytotoxic)
- ISO 10993-10:2010 Biological Evaluation of Medical Devices. Part 10- Test for Irritation and Skin Sensitization. Results: Non-Sensitizer (Predicate: Under the conditions of study, not a sensitizer)
- ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. Results: Pass (Predicate: Under the conditions of study, does not induce any acute systemic toxicity concern)
- ISO 10993-23:2021 Biological Evaluation of Medical Devices, Part 23: Tests for Irritation-Primary. Results: Non-Irritant (Predicate: Under the conditions of study, not an irritant)
Performance Testing (Bench):
- Physical performance qualities evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D412-Test methods for Vulcanized Rubber and Thermoplastic Elastomers- Tension (Tensile Strength and Ultimate Elongation before and after aging). Results: Met acceptance criteria for all sizes (14MPa min tensile strength, 500% min elongation before aging; 14MPa min tensile strength, 400% min elongation after aging). Predicate showed same results.
- ASTM D573-Test Method for Rubber-Deterioration in an Air Oven. Results: Average Values for Subject Device (Tensile Strength: 19.0 MPa before aging, 22.6 MPa after aging; Ultimate Elongation: 610% before aging, 486% after aging).
- ASTM D3767- Practice Rubber Examination Gloves. Not found in results.
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves. Results: Meets the requirement when tested (AQL = 2.5). Predicate complies with AQL 2.5.
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves. Results: 0.54 mg/Glove (Limit: 240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Cyclophosphamide (20 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Dacarbazine (10 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Doxorubicin HCL (2 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Etoposide (20 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Fluorouracil (50 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Mitomycin C (0.5 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Paclitaxel (60 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Thiotepa (10 mg/ml): 40.6 min (Subject Device), 64.8 min (Predicate). Observation: Slight swelling and no degradation. Warning: Do Not Use with Thiotepa.
- Vincristine Sulfate (1 mg/ml): >240 min (Subject Device and Predicate). Observation: Slight swelling and no degradation.
- Fentanyl/Citrate Injection (100mcg / 2mL): >240 min (Subject Device and Predicate). Observation: Slight swelling and degradation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Applicable (Performance metrics for gloves are based on physical and chemical resistance, not diagnostic accuracy).
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
October 2, 2023
Isikel Manufacturing LLC % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K232064
Trade/Device Name: Powder-Free Frost Nitrile Examination Gloves (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, OPJ, QDO Dated: July 10, 2023 Received: July 11, 2023
Dear Yolanda Smith:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Allan Gu
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232064
Device Name
Powder-Free Frost Nittile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate)
Indications for Use (Describe)
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration |
|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) |
| Cisplatin | 1 mg/ml (1,000 ppm) |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) |
| Dacarbazine | 10 mg/ml (10,000 ppm) |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) |
| Etoposide | 20 mg/ml (20,000 ppm) |
| Fluorouracil | 50 mg/ml (50,000 ppm) |
| Mitomycin C | 0.5 mg/ml (500 ppm) |
| Paclitaxel | 60 mg/ml (6,000 ppm) |
| Thiotepa | 10 mg/ml (10,000 ppm) |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) |
| Fentanyl/Citrate Injection | 100 mcg/2mL |
Breakthrough Detection Time 16.2 (16.2,21.6,21.9) min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. >240 min. 40.6 (70.6,40.6,40.6) min. >240 min. >240min.
Please note the following drugs have low permeation times: Carmustine 3.3 mg/ml (3,300 ppm) 16.2 minutes Thiotepa 10 mg/ml (10,000 ppm) 40.6 minutes 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Submitter's Information | |
|---|---|
| Company: | Isikel Manufacturing LLC. |
| Address: | 28350 West Ten Blvd. |
| Katy, TX 77494 | |
| Phone: | 832-523-2027 |
| Contact: | Christopher Betts |
| Email: | chris.betts@isikelmfg.com |
| Date Prepared: | October 2, 2023 |
| Designated Submission Correspondent | |
|---|---|
| Name | Yolanda Smith |
| Company: | Smith Associates |
| Address: | 1468 Harwell Avenue |
| Crofton, MD 21114 | |
| Phone | 888-729-9674 x 203 |
| Email: | ysmith@fdaconsultants.com |
| Email: | ysmith@fdaconsultants.com |
|---|---|
| Device Information and Name | |
| Trade Name: | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) |
| Common Name: | Patient Examination Gloves, Specialty |
| Classification Name: | Polymer Patient Exam Glove, Medical Gloves with Chemotherapy Labeling Claims |
| Product Code: | LZA- Polymer Patient Examination Glove |
| Product Code: | LZC- Patient Examination Glove, Specialty |
| Product Code: | OPJ- Medical Gloves with Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Product Code | QDO - Fentanyl And Other Opioid Protection Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Device Class: | Class I, Reserved |
| Reviewing Panel: | General Hospital |
| Basis for Submission: | New Device 510(k) |
4
| Predicate Device K211810 | |
|---|---|
| Manufacturer | PT. Shamrock Manufacturing Corporation |
| Device Name | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for |
| use with Chemotherapy Drugs and Fentanyl Citrate) | |
| Regulation No. | |
| Regulation Name | 21 CFR 880.6250 |
| Non-Powdered Patient Examination Glove | |
| 510 (K) Number | K211810 |
| Regulatory Class | 1 |
| Product Code | LZA, LZC, OPJ, QDO |
1. Device Description
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a Powder Free Nitrile Examination Glove. The subject device is a patient examination glove manufactured 100% nitrile-Butadiene Copolymer dispersion), Per 21 CFR 880.6250, Product codes LZA, LZC, OPJ, QDO and Class 1, Blue Color, Powder Free and Non-Sterile. The device meets the specifications in ASTM D6319-19. Standard specifications for Nitrile Examination Gloves. The glove sizes provided are Small, Medium, Large, and X-Large. The gloves design features include ambidextrous and textured fingers. The subject device complies with requirements for standard practice for assessment of resistance of medical glove to permeation by chemotherapy drugs as per ASTM D6978-05 (2019).
2. Indications for Use
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
| Tested Chemotherapy Drug
| Name | Concentration | Breakthrough Detection Time |
|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | 16.2 (16.2.21.6,21.9) min. |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. |
5
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. |
|---|---|---|
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 min. |
| Paclitaxel | 60 mg/ml (6,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 40.6 (70.6,40.6,40.6) min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Fentanyl/Citrate Injection | 100mcg / 2mL | >240 min. |
Please note the following drugs have low permeation times: Carmustine 3.3 mg/ml (3,300 ppm) 16.2 Minutes Thiotepa 10 mg/ml (10,000 ppm) 40.6 Minutes Warning: Do Not Use with Carmustine and Thiotepa
| Characteristics | Subject Device | Predicate Device
K211810 | Comparison |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| K Number | | K211810 | |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Indications for use | Powder-Free Frost Nitrile
Examination Gloves (Blue)
(Tested for use with
Chemotherapy Drugs and
Fentanyl Citrate) is a
disposable device intended for
medical purposes that is worn
on the examiner's hands to
prevent contamination
between patient and examiner.
In addition, these gloves were
tested for use with
Chemotherapy drugs and
Fentanyl Citrate in
accordance with ASTM
D6978-05
Carmustine 3.3 mg/ml (3,300
ppm)
16.2 (16.2.21.6,21.9) min.
Cisplatin
1 mg/ml (1,000 ppm)
240 min. | A patient examination glove
is a disposable device
intended for medical purpose
that is worn on examiner's
hand to
prevent contamination
between patient and
examiner. These gloves were
tested for use with
Chemotherapy Drugs as per
ASTM D6978-05(2019)
Standard Practice for
Assessment of Medical
Gloves to Permeation by
Chemotherapy Drugs and
Fentanyl. The following
chemicals have been tested
with these gloves:
Chemotherapy Drug and
Concentration Breakthrough
Detection Time in Minutes
Carboplatin (Paraplatin), 10
mg/ml (10,000ppm) > 240
min. | Same for
indications
for use
statement and
for all
comparative
chemotherapy
drugs. |
| Characteristics | Subject Device | Predicate Device
K211810 | Comparison |
| | Cyclophosphamide 20
mg/ml (20,000 ppm)
240 min.
Dacarbazine 10 mg/ml
(10,000 ppm)
240 min.
Doxorubicin HCL 2 mg/ml
(2,000 ppm)
240 min.
Etoposide 20 mg/ml (20,000
ppm)
240 min.
Fluorouracil 50 mg/ml
(50,000 ppm)
240 min.
Mitomycin C 0.5 mg/ml (500
ppm)
240 min.
Paclitaxel 60 mg/ml (6,000
ppm)
240 min.
Thiotepa 10 mg/ml (10,000
ppm)
40.6 (70.6,40.6,40.6) min.
Vincristine Sulfate 1 mg/ml
(1,000 ppm)
240 min.
Fentanyl/Citrate Injection
100mcg / 2mL >240 min.
Please note the following
drugs have low permeation
times:
Carmustine 3.3 mg/ml (3,300
ppm) 16.2(16.2.21.6,21.9)
Minutes
Thiotepa 10 mg/ml (10,000
ppm) 40.6 (70.6,40.6,40.6)
Minutes
Warning: Do Not Use with
Carmustine and Thiotepa | Carmustine (BCNU), 3.3
mg/ml (3,300ppm) 46.6 min.
Chloroquine 50mg/ml
(50,000ppm) > 240 min
Cisplatin, 1.0 mg/ml
(1,000ppm) > 240 min
Cyclophosphamide
(Cytoxan), 20.0mg/ml
(20,000 ppm) > 240 min
Dacarbazine, 10.0mg/ml
(10,000ppm) > 240 min
Docetaxel, 10mg/ml
(10,000ppm) > 240 min
Doxorubicin HCI, 2.0mg/ml
(2,000ppm) > 240 min
Etoposide, 20.0mg/ml
(20,000ppm) > 240 min
Fluorouracil, 50.0mg/ml
(50,000ppm) > 240 min
Ifosfamide, 50 mg/ml (50,000
ppm) > 240 min
Methotrexate, 25mg/ml
(25,000 ppm) > 240 min
Mitomycin C, 0.5 mg/ml (500
ppm) > 240 min
Paclitaxel, 6.0 mg/ml (6,000
ppm) > 240 min
Thiotepa, 10.0mg/ml
(10,000ppm) 64.8 min
Vincristine Sulfate, 1 mg/ml
(1,000 ppm) > 240 min
Fentanyl Citrate Injection
100mcg/2ml (50mcg/1ml) >
240 min
Please note that the following
drugs that have low
permeation time are:
Carmustine (BCNU), 3.3
mg/ml 46.6 min
Thiotepa, 10.0mg/ml 64.8
min
CAUTION: Testing showed
an average of breakthrough
time of 46.6 min for
Carmustine and 64.8 min for
Thiotepa. | |
| Powdered or Powder
free | Powder free | Powder free | Same |
| Material | Nitrile | Nitrile | Same |
| Characteristics | Subject Device | Predicate Device
K211810 | Comparison |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Color | Light Blue | Blue | Similar |
| Size | Small, Medium, Large, Extra
Large | X-Small, Small, Medium,
Large, X-Large, XX-large | Similar |
| Single Use vs
Reusable | Single use | Single use | Same |
| Residual Powder | Powder Free
240 min. | >240 Minutes | Same |
| Cyclophosphamide | 20 mg/ml
(20,000 ppm) | >240 min. | >240 Minutes | Same |
| Dacarbazine | 10 mg/ml
(10,000 ppm) | >240 min. | >240 Minutes | Same |
| Doxorubicin HCL | 2 mg/ml (2,000
ppm) | >240 min. | >240 Minutes | Same |
| Etoposide | 20 mg/ml
(20,000 ppm) | >240 min. | >240 Minutes | Same |
| Fluorouracil | 50 mg/ml
(50,000 ppm) | >240 min. | >240 Minutes | Same |
| Mitomycin C | 0.5 mg/ml (500
ppm) | >240 min. | >240 Minutes | Same |
| Paclitaxel | 60 mg/ml (6,000
ppm) | >240 min. | >240 Minutes | Same |
| Thiotepa | 10 mg/ml
(10,000 ppm) | 40.6 min
(70.6,40.6,40.6) | 64.8 Minutes | Different |
| Vincristine Sulfate | 1 mg/ml (1,000
ppm) | >240 min. | >240 Minutes | Same |
| Fentanyl/Citrate
Injection | 100mcg / 2mL | >240 min. | >240 Minutes | Same |
| Test Method | Purpose of Test | Subject Device | Predicate | Comparison of Test results |
|---|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions | |||
| To determine the Length | ||||
| and Width of Gloves | Complies with: ASTM D6319-19 | Complies with: | ||
| ASTM D6319-19 | Same |
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| Test
Method | Purpose of Test | Subject Device | Predicate | Comparison
of Test results |
|------------------|-----------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------|
| ASTM
D5151 | Watertightness Test for
Detection of Holes | Meets the requirement
when tested in
accordance with
ASTM D5151
AQL = 2.5 | Complies with:
ASTM D6319-
19 ASTM
D5151
AQL 2.5 | Same |
| ASTM
D6124-06 | To determine the residual
powder in gloves | Meets the requirement
of ASTM D6124 $240 min. | Slight swelling and no degradation |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. | Slight swelling and no degradation |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. | Slight swelling and no degradation |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. | Slight swelling and no degradation |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. | Slight swelling and no degradation |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. | Slight swelling and no degradation |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 min. | Slight swelling and no degradation |
| Paclitaxel | 60 mg/ml (6,000 ppm) | >240 min. | Slight swelling and no degradation |
| Thiotepa | 10 mg/ml (10,000 ppm) | 40.6 min | Slight swelling and no degradation |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | Slight swelling and no degradation |
| Fentanyl/Citrate
Injection | 100mcg / 2mL | >240 Minutes | Slight swelling and degradation |
| Test Performed | Acceptance Criteria | Results |
|---|---|---|
| ISO 10993-10:2010 | ||
| Skin Sensitization Test | Under the conditions of the | |
| study, not a sensitizer | Pass (Non- Sensitizer) |
14
| Test Performed | Acceptance Criteria | Results |
|---|---|---|
| ISO 10993-23:2021 | ||
| Intracutaneous Reactivity Test | Under the conditions of the | |
| study, not an irritant | Pass (Non-Irritant) | |
| ISO 10993-5:2009 | ||
| In vitro Cytotoxicity Test | Under the conditions of the | |
| study, non-cytotoxic | Was considered | |
| Cytotoxic | ||
| ISO 10993-11:2017 | ||
| Acute Systemic Toxicity Test | Under the conditions of the | |
| study, the device extracts do not | ||
| pose an acute systemic toxicity | ||
| concern. | Pass |
5. Discussion of Clinical Testing
Clinical testing is not needed for this device.
6. Conclusion
The conclusions from the non-clinical tests demonstrate that the Powder-Free Frost Nitrile Examination 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 predicate device that was cleared under K211280.