(98 days)
Not Found
No
The device is a simple disposable examination glove, and the summary focuses on material properties and chemical resistance testing, with no mention of AI/ML capabilities or related components.
No
The device is an examination glove, which is intended to prevent contamination between patient and examiner, serving as a barrier rather than providing therapy or treatment.
No
The device is described as an "examination glove" intended to prevent contamination. Its performance testing focuses on barrier properties and physical characteristics, not on detecting or identifying a medical condition or disease.
No
The device is described as a "disposable examination glove" made of "Synthetic: Nitrile & Polychloroprene," which are physical materials, not software. The testing performed relates to the physical properties and chemical resistance of the glove.
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 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 infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description confirms it's an examination glove made of synthetic materials.
- Testing Performed: While testing was done for breakthrough times against various chemicals, this testing is to demonstrate the protective barrier function of the glove, not to diagnose or analyze a patient sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with IVD devices.
In summary, the device is a medical device used for protection and infection control, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 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.
Testing was performed to determine Break-through times for the Chemotherapy drugs listed below, plus the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Testing was conducted to demonstrate that the two proposed devices met all required design specifications. The test results demonstrated that the proposed devices did meet the performance criteria as specified utilizing the following test method standards and specifications:
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application - Pass
ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension - Pass
ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven - Pass
ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions - Pass
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes in Medical Gloves - Pass
ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder on Medical Gloves - Pass
ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs - Pass
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes - Pass
ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation and Sensitization - Pass
ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2020
Kimberly Clark Corporation % Wava Truscott Consultant Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, Georgia 30075
Re: K202416
Trade/Device Name: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid. Kimtech Prizm Xtra Multi-Lavered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO Dated: November 25, 2020 Received: November 30, 2020
Dear Wava Truscott:
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 and Part 809; 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,
For: Elizabeth F. Claverie, MS 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
2
510(k) Number: K202416
=
Device 1.) Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
| Indications for Use (Describe):
| CHEMICAL | CONCENTRATION | STANDARD LENGTH |
|---|---|---|
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 47.5 min. |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. |
| 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. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| Pemetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 38.2 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFFEMAILADDRESS BELOW®
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number"
Form FDA 3881 (7/17)
3
510(k) Number: K202416
Device 2.) Trade Name: KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
| Indications for Use (Describe): | ||
|---|---|---|
| CHEMICAL | CONCENTRATION | XTRA |
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 37.3 min. |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. |
| 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. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. |
| Pemetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 30.1 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
| Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min. respectively |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFFEMAILADDRESS BELOW
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number'
4
510(k) Number: K202416
510(k) Summary as required by 807.92(c) FDA Format: Traditional 510k
Preparation Date: November 22, 2020
KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Trade Name: Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
KIMTECH™ PRIZMTM Xtra Multi-Layered Exam Glove Tested for use Trade Name: with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
1. Submitter:
| Company Name: | Kimberly-Clark Corporation |
|---|---|
| Address: | 1400 Holcomb Bridge Road |
| Roswell, GA 30076 | |
| Country: | United States |
| General phone: | +1 770-587-8000 |
| Contact Person: | Juan M. Marquez |
| Director, Regulatory Affairs | |
| Kimberly-Clark Corporation | |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30076 | |
| E-mail: | Juan.M.Marquez@kcc.com |
| Phone: | +1 678-352-6069 |
| Fax: | +1 920-969-4863 |
2. Device information:
Device Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
KIMTECH™ PRIZM TM Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
Classification name: Per 21 CFR 807.92(a)2(2): Patient Examination Glove
General Hospital and Personal Use Devices
Synthetic Non-powdered Exam Glove Common name:
Class: Class I (general controls)
Product Codes: LZA, LZC, QDO
5
Indications for use:
Intended Use: The 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.
Testing was performed to determine Break-through times for the Chemotherapy drugs listed below, plus the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
KIMTECH™ PRIZM™M Multi-Layered Gloves: ASTM D6978-05 (2019): "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs"
| CHEMICAL | CONCENTRATION | STANDARD Length |
|---|---|---|
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 47.5 min. |
| Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. |
| 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. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide, | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| Permetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 38.2 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
| Caution: Carmustine and Thiotepa have low penetration times of 47.5 min. and 38.2 min. | ||
| respectively |
KIMTECH™ PRIZMTM Multi-Lavered Glove:
Caution: Carmustine and Thiotepa have breakthrough times of less than 60 minutes at 47.5 min. and 38.2 min. respectively
6
Indications for use:
Intended Use: The 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.
Testing was performed to determine Break-through times for the Chemotherapy drugs listed below, plus the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Trade Name: KIMTECHTM PRIZM TM Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
| CHEMICAL | CONCENTRATION | Xtra |
|---|---|---|
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 37.3 min. |
| Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. |
| 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. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide, | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| Permetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 30.1 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
| Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min. | ||
| respectively |
KIMTECH™ PRIZM™ Xtra Multi-Layered Glove:
Caution: Carmustine and Thiotepa have breakthrough times of less than 60 minutes at 37.3 min. and 30.1 min. respectively
7
Subject Gloves Technological Characteristics Comparison Table
Predicate K200072 & K202416 Subject Gloves: Standard & Xtra Length
| Attributes | Standard
Test | Predicate Device:
K200072 | Subject Glove 1
(standard length)
K202416 | Subject Glove 2
(Xtra-length)
K202416 | Comparison |
|---------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | NA | Synthetic Examination
Glove | Synthetic
Examination
Glove | Synthetic
Examination
Glove | Same |
| Intended Use | NA | The 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. | The 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. | The 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. | Same |
| Base Material | NA | Synthetic: Nitrile | Synthetic:
Nitrile &
Polychloroprene | Synthetic:
Nitrile &
Polychloroprene | Similar:
Predicate and
both Subject
gloves are
Synthetic
Both Predicate
and Subject
gloves possess
nitrile
Subject gloves
also have
polychloroprene
in their
formulation
Does not
adversely
impact safety or
performance |
| Color | NA | Purple | Dark Violet outer
surface
Deep Magenta inside
surface | Dark Violet outer
surface
Deep Magenta inside
surface | Different
Subject gloves
have different
inner & outer
surface colors.
Does not
adversely
impact safety or
performance |
| Product code | NA | LZA, LZC, ODO | LZA, LZC, ODO | LZA, LZC, ODO | Same |
| Attributes | Standard
Test | Predicate Device:
K200072 | Subject Glove 1
(standard length)
K202416 | Subject Glove 2
(Xtra-length)
K202416 | Comparison |
| Sterile vs. non-
sterile | NA | Non-sterile | Non-sterile | Non-sterile | Same |
| Prescription or
OTC | NA | OTC | OTC | OTC | Same |
| Single Use-
Disposable | NA | Yes | Yes | Yes | Same |
| Indications for
use (summary) | ASTM
D1678-05 | Glove was Tested
for use with
chemotherapy
drugs, the Opioid
Fentanyl Citrate,
simulated Gastric
acid, and Fentanyl
in Gastric Acid | Glove was Tested for
use with
chemotherapy drugs,
the Opioid Fentanyl
Citrate, simulated
Gastric acid, and
Fentanyl in Gastric
Acid | Glove was Tested for
use with
chemotherapy drugs,
the Opioid Fentanyl
Citrate, simulated
Gastric acid, and
Fentanyl in Gastric
Acid | Same:
Test Method
Same:
Fentanyl
Citrate,
simulated
Gastric Acid
and Fentanyl in
Gastric Acid
Similar:
Chemotherapy
Chemicals
tested
(see below) |
| Chemicals
Tested | ASTM
D1678-05 | Chemotherapy
drugs tested:
Carmustine
(BCNU)
Cisplatin,
Cyclophosphamide
(Cytoxan),
Dacarbazine
(DTIC)
Doxorubicin
Hydrochloride,
Etoposide
(Toposar)
Fluorouracil,
Methotrexate
Paclitaxel (Taxol),
Thiotepa
Vincristine Sulfate | Chemotherapy
drugs tested:
Cabazitaxel
Capecitabine
Carmustine
Cisplatin,
Cyclophosphamide
Dacarbazine
Doxorubicin HCL
Eribulin Mesylate
Etoposide
Floxuridine
Fluorouracil
Ifosfamide,
Lenvatinib
Mitoxantrone
Paclitaxel,
Permetrexed
Sorafenib Tosylate
Tamoxifen
Thiotepa
Vinblastine Sulfate
Vincristine Sulfate
Vinorelbine | Chemotherapy
drugs tested:
Cabazitaxel
Capecitabine
Carmustine
Cisplatin,
Cyclophosphamide
Dacarbazine
Doxorubicin HCL
Eribulin Mesylate
Etoposide
Floxuridine
Fluorouracil
Ifosfamide,
Lenvatinib
Mitoxantrone
Paclitaxel,
Permetrexed
Sorafenib Tosylate
Tamoxifen
Thiotepa
Vinblastine Sulfate
Vincristine Sulfate
Vinorelbine | Similar:
Some
chemotherapy
drugs are
different |
| Attributes | Standard
Test | Predicate Device:
K200072 | Subject Glove 1
(standard length)
K202416 | Subject Glove 2
(Xtra-length)
K202416 | Comparison |
| Caution/
Warning
Statements | NA | In Addition: Fentanyl
Citrate simulated
Gastric Acid,
Fentanyl in Gastric
Acid
Note: Carmustine
and Thiotepa have
extremely low
permeation times
of 3.6 &15.9 min.
respectively.
WARNING: Do
Not Use With:
Carmustine,
Thiotepa | In Addition: Fentanyl
Citrate simulated
Gastric Acid,
Fentanyl in Gastric
Acid
Caution:
Carmustine and
Thiotepa have low
permeation times
below 60
minutes at 47.5
min and 38.2 min.
respectively | In Addition: Fentanyl
Citrate simulated
Gastric Acid,
Fentanyl in Gastric
Acid
Caution:
Carmustine and
Thiotepa have low
permeation times
below 60
minutes at 37.3
min and 30.1 min.
respectively | Different
The predicate
has a Warning
while both
Subject Glove 1
and 2 have
Caution
statement |
| Dimensions:
Overall Length | ASTM D6319
Minimum:
230mm | All sizes comply with
length dimensions | All sizes comply with
length dimensions | All sizes comply with
length dimensions | Same |
| Dimensions:
Overall Width | ASTM D6319
Minimum: 110
- 10mm | All sizes comply with
length dimensions | All sizes comply with
length dimensions | All sizes comply with
length dimensions | Same |
| Dimensions:
Palm &
Finger
Thickness | ASTM D6319
Minimum:
Palm: 0.05mm
Finger:
0.05mm | All sizes comply with
length dimensions | All sizes comply with
length dimensions | All sizes comply with
length dimensions | Same |
| Tensile
strength:
Before & After
Aging | ASTM D6319
Minimum
Before: 14MPa
After: 14MPa | Complies both
before and after
accelerated aging | Complies both
before and after
accelerated aging | Complies both
before and after
accelerated aging | Same |
| Ultimate
elongation
Before &
After aging | ASTM D6319
Minimum:
Before: 500%
After:
400% | Complies both before
and after accelerated
aging | Complies both before
and after accelerated
aging | Complies both before
and after accelerated
aging | Same |
| Attributes | Standard Test | Predicate Device:
K200072 | Subject Glove 1
(standard length)
K202416 | Subject Glove 2
(Xtra-length)
K202416 | Comparison |
| Freedom from holes | ASTM D6319
G1,
AQL 2.5
7 Accept
8 Reject | Pass | Pass | Pass | Same |
| Powder Free | ASTM 6319
Maximum