(109 days)
Not Found
No
The document describes surgical gloves and their resistance to chemotherapy drugs, with no mention of AI or ML technology.
No
The device is described as a barrier to prevent exposure to contaminants and infectious materials, not to treat a disease or condition.
No
Explanation: The device is a surgical glove intended to provide a barrier against infectious materials and contaminants, not to diagnose a condition or disease.
No
The device is described as a physical glove made of polyisoprene or polychloroprene, intended for use as a barrier. There is no mention of software as the primary or sole component of the device.
Based on the provided text, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for providing a barrier against potentially infectious materials and other contaminants, primarily in surgical settings. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the material and physical characteristics of the gloves.
- Performance Studies: The performance studies described are related to the glove's resistance to chemotherapy drugs (permeation), which is a measure of its barrier function, not a diagnostic capability.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
The testing for chemotherapy drug resistance is a performance characteristic of the glove as a barrier, not an indication that the glove itself is performing a diagnostic test.
N/A
Intended Use / Indications for Use
Biogel PI Indicator Underglove tested for use with chemotherapy agents: The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel PI Micro tested for use with chemotherapy agents: The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel PI UltraTouch tested for use with chemotherapy agents: A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel PI tested for use with chemotherapy agents: A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel Skinsense Indicator Underglove tested for use with chemotherapy agents: A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
The Biogel surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene.
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
Surgical settings
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: In support of the "tested for use with chemotherapy agents" claim, the permeation of the subject devices by specific chemotherapy drugs was evaluated according to ASTM D6978-05 (2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough detection time in minutes (0.01µg/cm²/mins) for various chemotherapy drugs, ranging from 6.6 minutes to >240 minutes depending on the glove type and drug.
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
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 logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 10, 2020
Molnlycke Health Care US LLC. Calen Souther Regulatory Affairs Specialist 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K193573
Trade/Device Name: Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents, Biogel® PI UltraTouch® tested for use with chemotherapy agents, Biogel® PI Indicator® Underglove tested for use with chemotherapy agents, Biogel® PI tested for use with chemotherapy agents, Biogel® PI Micro tested for use with chemotherapy agents
Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: January 16, 2020 Received: January 21, 2020
Dear Calen Souther:
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 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,
CAPT Elizabeth Claverie, M.S. 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
Indications for Use
510(k) Number (if known) K193573
Device Name
Biogel PI Indicator Underglove tested for use with chemotherapy agents
Indications for Use (Describe)
The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
[continued on next page]
| 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)
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 STAFF EMAIL ADDRESS 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."
3
[K193573 Indications for Use, continued]
| Biogel® PI Indicator® Underglove
| Tested for use with chemotherapy agents | |
|---|---|
| Drug and Concentration | Breakthrough detection time in |
| minutes (0.01µg/cm²/mins) | |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 17.3 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | |
| 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride | |
| 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 24.1 |
| Vincristine Sulfate 1 mg/ml | >240 |
- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 17.3 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 24.1 minutes
4
Indications for Use
510(k) Number (if known) K193573
Device Name
Biogel PI Micro tested for use with chemotherapy agents
Indications for Use (Describe)
The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
[continued on next page]
| 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)
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 STAFF EMAIL ADDRESS 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."
5
[K193573 Indications for Use, continued]
| Biogel® PI Micro
| Tested for use with chemotherapy agents | |
|---|---|
| Drug and Concentration | Breakthrough detection time in |
| minutes (0.01µg/cm²/mins) | |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 10.0 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | |
| 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride | |
| 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 20.3 |
| Vincristine Sulfate 1 mg/ml | >240 |
- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 10.0 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 20.3 minutes
6
Indications for Use
510(k) Number (if known) K193573
Device Name
Biogel PI UltraTouch tested for use with chemotherapy agents
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
[continued on next page]
| 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)
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 STAFF EMAIL ADDRESS 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."
7
[K193573 Indications for Use, continued]
| Biogel® PI UltraTouch | |
|---|---|
| Tested for use with chemotherapy agents | |
| Drug and Concentration | Breakthrough detection time in minutes (0.01µg/cm²/mins) |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 24.2 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 17.9 |
| Vincristine Sulfate 1 mg/ml | >240 |
- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 24.2 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 17.9 minutes
8
Indications for Use
510(k) Number (if known) K193573
Device Name
Biogel PI tested for use with chemotherapy agents
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
[continued on next page]
| 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)
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 STAFF EMAIL ADDRESS 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."
9
[K193573 Indications for Use, continued]
| Drug and Concentration | Breakthrough detection time in
minutes (0.01µg/cm²/mins) |
|----------------------------------------|-------------------------------------------------------------|
| | |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 26.7 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan)
20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride
2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 28.7 |
| Vincristine Sulfate 1 mg/ml | >240 |
- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 26.7 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 28.7 minutes
10
Indications for Use
510(k) Number (if known) K193573
Device Name
Biogel Skinsense Indicator Underglove tested for use with chemotherapy agents
Indications for Use (Describe)
A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
[continued on next page]
| 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)
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 STAFF EMAIL ADDRESS 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."
11
[K193573 Indications for Use, continued]
| Drug and Concentration | Breakthrough detection time in |
|---|---|
| minutes (0.01µg/cm²/mins) | |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 6.6 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 16.9 |
| Vincristine Sulfate 1 mg/ml | >240 |
- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 6.6 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 16.9 minutes
12
510(k) Summary
The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | March 23, 2020 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC. |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration Number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Calen Souther |
| Regulatory Affairs Specialist | |
| Phone: 770-595-4222 | |
| Fax: 678-245-7746 | |
| Email: calen.souther@molnlycke.com | |
| Trade/Proprietary Names: | Biogel® Skinsense® Indicator® Underglove tested for use with |
| chemotherapy agents | |
| Biogel® PI UltraTouch® tested for use with chemotherapy | |
| agents | |
| Biogel® PI Indicator® Underglove tested for use with | |
| chemotherapy agents | |
| Biogel® PI tested for use with chemotherapy agents | |
| Biogel® PI Micro tested for use with chemotherapy agents | |
| Common Name: | Surgeon's Gloves |
| Regulation Name: | Non-powdered surgeon's gloves |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 878.4460 |
| Product Code: | KGO, LZC |
| Predicate Device Information: | K140477 |
| Biogel® PI UltraTouch® G Surgical Glove tested for use with | |
| chemotherapy agents | |
| Biogel® Skinsense® Surgical Glove tested for use with | |
| chemotherapy agents |
13
Reason for 510(k) submission
The purpose of this Traditional 510(k) submission is to add a "Tested for use with chemotherapy agents" claim to the following existing, 510(k) cleared surgical gloves: Biogel® Skinsense® Underglove, Biogel® Pl UltraTouch®, Biogel® PI Indicator® Underglove, Biogel® PI, Biogel® PI Micro.
Description of Devices
The Biogel® surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene. Refer to Tables 6-1 to 6-5 for a detailed description of the technological characteristics and comparison to the applicable predicate device.
Indications for Use
Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents
A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
| Drug and Concentration | Breakthrough
detection time in
minutes
(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 6.6 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide
(Cytoxan)
20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10
mg/ml | >240 |
| Doxorubicin
Hydrochloride
2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20
mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1
mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
14
| Mitomycin C 0.5 mg/ml | >240 |
|---|---|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 16.9 |
| Vincristine Sulfate 1 mg/ml | >240 |
- Carmustine (3.3 mg/ml) has a minimum breakthrough time of 6.6 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 16.9 minutes
Biogel® PI Micro tested for use with chemotherapy agents
The Biogel Pl Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
| Drug and Concentration | Breakthrough
detection time in
minutes
(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 10.0 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide
(Cytoxan)
20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10
mg/ml | >240 |
| Doxorubicin
Hydrochloride
2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20
mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1
mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
15
| Mitomycin C 0.5 mg/ml | >240 |
|---|---|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 20.3 |
| Vincristine Sulfate 1 mg/ml | >240 |
- Carmustine (3.3 mg/ml) has a minimum breakthrough time of 10.0 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 20.3 minutes
Biogel® PI UltraTouch® tested for use with chemotherapy agents
A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
| Drug and Concentration | Breakthrough detection time in minutes (0.01µg/cm²/mins) |
|---|---|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 24.2 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
16
| Mitomycin C 0.5 mg/ml | >240 |
|---|---|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 17.9 |
| Vincristine Sulfate 1 mg/ml | >240 |
- Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 24.2 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 17.9 minutes
Biogel® PI tested for use with chemotherapy agents
A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
| Drug and Concentration | Breakthrough
detection time in
minutes
(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 26.7 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide
(Cytoxan)
20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10
mg/ml | >240 |
| Doxorubicin
Hydrochloride
2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20
mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1
mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
17
| Mitomycin C 0.5 mg/ml | >240 |
|---|---|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 | |
| mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 28.7 |
| Vincristine Sulfate 1 | |
| mg/ml | >240 |
- Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 26.7 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 28.7 minutes
Biogel® PI Indicator® Underglove tested for use with chemotherapy agents
The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
| Drug and Concentration | Breakthrough
detection time in
minutes
(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 17.3 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide
(Cytoxan)
20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10
mg/ml | >240 |
| Doxorubicin
Hydrochloride
2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20
mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1
mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
18
| Mitomycin C 0.5 mg/ml | >240 |
|---|---|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 24.1 |
| Vincristine Sulfate 1 mg/ml | >240 |
- . Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 17.3 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 24.1 minutes ■
19
| Table 6-1: Technological Characteristics Comparison |
|---|
| ----------------------------------------------------- |
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Feature | Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents | Biogel® Skinsense® Surgical Glove tested for use with chemotherapy agents | |
| 510(k) clearance | Originally cleared under K053102; subject of this premarket notification to add "tested for use with chemotherapy agents" claim | K140477 | |
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | |
| Regulation | 21 CFR 878.4460, | 21 CFR 878.4460, | |
| Class Name | Surgeon's Gloves | Surgeon's Gloves | |
| Classification | Class I | Class I | |
| Product Code | KGO, LZC | KGO, LZC | |
| Indication for Use | A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. |
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: | Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | |
| | Drug and Concentration
Breakthrough detection time in minutes (0.01µg/cm²/mins)
Bleomycin 15 mg/ml >240
Busulfan 6 mg/ml >240
Carmustine 3.3 mg/ml 6.6
Cisplatin 1.0 mg/ml >240
Cyclophosphamide (Cytoxan) 20 mg/ml >240
Cytarabine 100 mg/ml >240 | Drug and Concentration
Breakthrough detection time in minutes (0.01µg/cm²/mins)
Bleomycin 15 mg/ml >240
Busulfan 6 mg/ml >240
Carmustine 3.3 mg/ml 60.2
Cisplatin 1.0 mg/ml >240
Cyclophosphamide (Cytoxan) 20 mgl/ml >240
Cytarabine 100 mg/ml >240
Dacarbazine (DTIC) 10 mg/ml >240 | |
| Dacarbazine (DTIC) 10 mg/ml | >240 | Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | Ellence 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 | Etoposide (Toposar) 20 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | Fludarabine 25 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 | Fluorouracil 50 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 | Idarubicin 1 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 | Ifosfamide 50 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 | Mechlorethamine HCl 1 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | Melphalan 5 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 | Methotrexate 25 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 | Mitomycin C 0.5 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 | Mitoxantrone 2 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 | Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | Paraplatin 10 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 | Rituximab 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 | Thiotepa 10 mg/ml | 75.8 |
| Thiotepa 10 mg/ml | 16.9 | Trisenox 0.1 mg/ml | >240 |
| Vincristine Sulfate 1 mg/ml | >240 | Vincristine Sulfate 1 mg/ml | >240 |
| Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 6.6 minutes. Thiotepa (10 mg/ml) has a minimum breakthrough time of 16.9 minutes | | Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 60.2 minutes. Thiotepa (10 mg/ml) has a minimum breakthrough time of 75.8 minutes | |
| Design | Single-use
Sterile
Powder-free
Hand specific
Beaded cuff | | Single-use
Sterile
Powder-free
Hand specific
Beaded cuff |
| Material | Synthetic Polychloroprene | | Synthetic Polychloroprene |
| Sterilization
Method | Irradiation | Irradiation | |
| Sterility (SAL) | 10-6 | 10-6 | |
| Color | Blue | Straw (Natural) | |
| Shelf Life | 3-years | 3-years | |
| Resistance to
Permeation by
Chemotherapy
Drugs | Meets ASTM D6978-05 (2019) | Meets ASTM D6978-05 (2019) | |
| Freedom from
Holes | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015)
requirements | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015) requirements | |
| Powder Residue | Meets requirements of ≤ 2.0 mg/glove for Powder-free
designation per ASTM D3577-09 (2015) | Meets requirements of ≤ 2.0 mg/glove for Powder-free designation
per ASTM D3577-09 (2015) | |
| Dimensions and
Physical
Properties | Meets ASTM D3577-09 (2015) | Meets ASTM D3577-09 (2015) | |
20
21
22
Table 6-2: Technological Characteristics Comparison
| Feature | Subject Device
Biogel® PI Micro tested for use with chemotherapy agents | Predicate Device
Biogel® PI UltraTouch® G Surgical Glove tested for use with chemotherapy agents | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| 510(k) clearance | Originally cleared under K141719; subject of this premarket notification to add "tested for use with chemotherapy agents" claim | K140477 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation | 21 CFR 878.4460, 21 CFR 878.6250 | 21 CFR 878.4460, 21 CFR 878.6250 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Class Name | Surgeon's Gloves | Surgeon's Gloves | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification | Class I | Class I | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product Code | KGO, LZC | KGO, LZC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Indication for Use | The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: | Biogel® PI UltraTouch® G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Drug and Concentration Breakthrough detection time in minutes (0.01µg/cm²/mins) Bleomycin 15 mg/ml >240 Busulfan 6 mg/ml >240 Carmustine 3.3 mg/ml 10.0 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20 mg/ml >240 Cytarabine 100 mg/ml >240 Dacarbazine (DTIC) 10 mg/ml >240 Doxorubicin Hydrochloride 2 mg/ml >240 | | | | | | | | | | | | | | | | | | | Drug and Concentration Breakthrough detection time in minutes (0.01µg/cm²/mins) Bleomycin 15 mg/ml >240 Busulfan 6 mg/ml >240 Carmustine 3.3 mg/ml 12.1 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20 mgl/ml >240 Cytarabine 100 mg/ml >240 Dacarbazine (DTIC) 10 mg/ml >240 Doxorubicin Hydrochloride 2 mg/ml >240 | | | | | | | | | | | | | | | | | | |
23
| Ellence 2 mg/ml | >240 | Ellence 2 mg/ml | >240 |
|---|---|---|---|
| Etoposide (Toposar) 20 mg/ml | >240 | Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 | Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 | Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 | Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 | Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 | Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 | Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 | Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 | Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 | Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 | Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 20.3 | Thiotepa 10 mg/ml | 15.5 |
| Vincristine Sulfate 1 mg/ml | >240 | Trisenox 0.1 mg/ml | >240 |
| Vincristine Sulfate 1 mg/ml | >240 | ||
| Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs: | Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs: | ||
| • Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 10.0 minutes. | • Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 12.1 minutes. | ||
| • Thiotepa (10 mg/ml) has a minimum breakthrough time of 20.3 minutes | • Thiotepa (10 mg/ml) has a minimum breakthrough time of 15.5 minutes | ||
| Design | Single-use | ||
| Sterile | |||
| Powder-free | |||
| Hand specific | |||
| Beaded cuff | Design | Single-use | |
| Sterile | |||
| Powder-free | |||
| Hand specific | |||
| Beaded cuff | |||
| Material | Synthetic Polyisoprene | Material | Synthetic Polyisoprene |
| Sterilization Method | Irradiation | Sterilization Method | Irradiation |
| Sterility (SAL) | 10-6 | Sterility (SAL) | 10-6 |
24
| Color | Straw (Natural) | Straw (Natural) |
|---|---|---|
| Shelf Life | 3-years | 3-years |
| Resistance to | ||
| Permeation by | ||
| Chemotherapy | ||
| Drugs | Meets ASTM D6978-05 (2019) | Meets ASTM D6978-05 |
| Freedom from | ||
| Holes | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015) | |
| requirements | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015) | |
| requirements | ||
| Powder Residue | Meets requirements of ≤ 2.0 mg/glove for Powder-free | |
| designation per ASTM D3577-09 (2015) | Meets requirements of ≤ 2.0 mg/glove for Powder-free | |
| designation per ASTM D3577-09 (2015) | ||
| Dimensions and | ||
| Physical | ||
| Properties | Meets ASTM D3577-09 (2015) | Meets ASTM D3577-09 (2015) |
25
Table 6-3: Technological Characteristics Comparison
| Feature | Subject Device | Predicate | |
|---|---|---|---|
| 510(k) clearance | Biogel® PI UltraTouch® tested for use with chemotherapy agents | ||
| Previously cleared under K050184; subject of this premarket notification to add "tested for use with chemotherapy agents" claim | Biogel® PI UltraTouch® G Surgical Glove tested for use with chemotherapy agents | ||
| K140477 | |||
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | |
| Regulation | 21 CFR 878.4460, 21 CFR 878.6250 | 21 CFR 878.4460, 21 CFR 878.6250 | |
| Class Name | Surgeon's Gloves | Surgeon's Gloves | |
| Classification | Class I | Class I | |
| Product Code | KGO, LZC | KGO, LZC | |
| Indication for Use | A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. |
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: | Biogel® PI UltraTouch® G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | |
| | Drug and Concentration | Drug and Concentration | |
| | Breakthrough detection time in minutes (0.01µg/cm²/mins) | Breakthrough detection time in minutes (0.01µg/cm²/mins) | |
| | Bleomycin 15 mg/ml
240 | Bleomycin 15 mg/ml
240 | |
| | Busulfan 6 mg/ml
240 | Busulfan 6 mg/ml
240 | |
| | Carmustine 3.3 mg/ml
24.2 | Carmustine 3.3 mg/ml
12.1 | |
| | Cisplatin 1.0 mg/ml
240 | Cisplatin 1.0 mg/ml
240 | |
| | Cyclophosphamide (Cytoxan) 20 mg/ml
240 | Cyclophosphamide (Cytoxan) 20 mgl/ml
240 | |
| | Cytarabine 100 mg/ml
240 | Cytarabine 100 mg/ml
240 | |
| | Dacarbazine (DTIC) 10 mg/ml
240 | Dacarbazine (DTIC) 10 mg/ml
240 | |
| | Doxorubicin Hydrochloride 2 mg/ml
240 | Doxorubicin Hydrochloride 2 mg/ml
240 | |
| Ellence 2 mg/ml | >240 | Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 | Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 | Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 | Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 | Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 | Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 | Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 | Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 | Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 | Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 | Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 17.9 | Thiotepa 10 mg/ml | 15.5 |
| Vincristine Sulfate 1 mg/ml | >240 | Trisenox 0.1 mg/ml | >240 |
| | | Vincristine Sulfate 1 mg/ml | >240 |
| Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs:
- Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 24.2 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 17.9 minutes | | Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs:
- Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 12.1 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 15.5 minutes | |
| Design | Single-use
Sterile
Powder-free
Hand specific
Beaded cuff | | Single-use
Sterile
Powder-free
Hand specific
Beaded cuff |
| Material | Synthetic Polyisoprene | | Synthetic Polyisoprene |
| Sterilization Method | Irradiation | | Irradiation |
| Sterility (SAL) | 10-6 | | 10-6 |
| Color | Straw (Natural) | Straw (Natural) | |
| Shelf Life | 3-years | 3-years | |
| Resistance to
Permeation by
Chemotherapy
Drugs | Meets ASTM D6978-05 (2019) | Meets ASTM D6978-05 | |
| Freedom from
Holes | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015)
requirements | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015)
requirements | |
| Powder Residue | Meets requirements of ≤ 2.0 mg/glove for Powder-free
designation per ASTM D3577-09 (2015) | Meets requirements of ≤ 2.0 mg/glove for Powder-free
designation per ASTM D3577-09 (2015) | |
| Dimensions and
Physical
Properties | Meets ASTM D3577-09 (2015) | Meets ASTM D3577-09 (2015) | |
26
27
28
Table 6-4: Technological Characteristics Comparison
| Feature | Subject Device | Predicate Device | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogel® Pl tested for use with chemotherapy agents | Biogel® PI UltraTouch® G Surgical Glove tested for use with chemotherapy agents | |||||||||||||||||||||||||||||||||||
| 510(k) clearance | Previously cleared under K050184/K053442; subject of this premarket notification to add "tested for use with chemotherapy agents" claim | K140477 | ||||||||||||||||||||||||||||||||||
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | ||||||||||||||||||||||||||||||||||
| Regulation | 21 CFR 878.4460, 21 CFR 878.6250 | 21 CFR 878.4460, 21 CFR 878.6250 | ||||||||||||||||||||||||||||||||||
| Class Name | Surgeon's Gloves | Surgeon's Gloves | ||||||||||||||||||||||||||||||||||
| Classification | Class I | Class I | ||||||||||||||||||||||||||||||||||
| Product Code | KGO, LZC | KGO, LZC | ||||||||||||||||||||||||||||||||||
| Indication for Use | A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. |
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: | Biogel® PI UltraTouch® G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Drug and Concentration
Drug and Concentration Breakthrough detection time in minutes (0.01µg/cm²/mins) Bleomycin 15 mg/ml >240 Busulfan 6 mg/ml >240 Carmustine 3.3 mg/ml 26.7 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20 mg/ml >240 Cytarabine 100 mg/ml >240 Dacarbazine (DTIC) 10 mg/ml >240 | | | | | | | | | | | | | | | | | Drug and Concentration Breakthrough detection time in minutes (0.01µg/cm²/mins) Bleomycin 15 mg/ml >240 Busulfan 6 mg/ml >240 Carmustine 3.3 mg/ml 12.1 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20 mgl/ml >240 Cytarabine 100 mg/ml >240 Dacarbazine (DTIC) 10 mg/ml >240 Doxorubicin Hydrochloride 2 mg/ml >240 | | | | | | | | | | | | | | | | | | |
29
| Doxorubicin
Hydrochloride
2 mg/ml | >240 | Ellence 2 mg/ml
Etoposide (Toposar) 20 mg/ml | >240 |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------|------|
| Ellence 2 mg/ml | >240 | Fludarabine 25 mg/ml | >240 |
| Etoposide (Toposar) 20
mg/ml | >240 | Fluorouracil 50 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 | Idarubicin 1 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 | Ifosfamide 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 | Mechlorethamine HCl 1
mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 | Melphalan 5 mg/ml | >240 |
| Mechlorethamine HCl 1
mg/ml | >240 | Methotrexate 25 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 | Mitomycin C 0.5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 | Mitoxantrone 2 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 | Paclitaxel (Taxol) 6
mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 | Paraplatin 10 mg/ml | >240 |
| Paclitaxel (Taxol) 6
mg/ml | >240 | Rituximab 10 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 | Thiotepa 10 mg/ml | 15.5 |
| Rituximab 10 mg/ml | >240 | Trisenox 0.1 mg/ml | >240 |
| Thiotepa 10 mg/ml | 28.7 | Vincristine Sulfate 1
mg/ml | >240 |
| Vincristine Sulfate 1
mg/ml | >240 | | |
| Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs: | | | |
| Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compared to other chemotherapy drugs: | | | |
| Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 26.7 minutes. | | Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 12.1 minutes. | |
| Thiotepa (10 mg/ml) has a minimum breakthrough time of 28.7 minutes | | Thiotepa (10 mg/ml) has a minimum breakthrough time of 15.5 minutes | |
| Design | Single-use
Sterile
Powder-free
Hand specific
Beaded cuff | Single-use
Sterile
Powder-free
Hand specific
Beaded cuff | |
| Material | Synthetic Polyisoprene | Synthetic Polyisoprene | |
| Sterilization
Method | Irradiation | Irradiation | |
30
| Sterility (SAL) | $10^{-6}$ | $10^{-6}$ |
|---|---|---|
| Color | Straw (Natural) | Straw (Natural) |
| Shelf Life | 3-years | 3-years |
| Resistance to | ||
| Permeation by | ||
| Chemotherapy | ||
| Drugs | Meets ASTM D6978-05 (2019) | Meets ASTM D6978-05 |
| Freedom from | ||
| Holes | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015) | |
| requirements | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015) | |
| requirements | ||
| Powder Residue | Meets requirements of ≤ 2.0 mg/glove for Powder-free | |
| designation per ASTM D3577-09 (2015) | Meets requirements of ≤ 2.0 mg/glove for Powder-free | |
| designation per ASTM D3577-09 (2015) | ||
| Dimensions and | ||
| Physical | ||
| Properties | Meets ASTM D3577-09 (2015) | Meets ASTM D3577-09 (2015) |
31
Table 6-5: Technological Characteristics Comparison
| Subject Device | Predicate Device | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feature | Biogel® PI Indicator® Underglove tested for use with chemotherapy agents | Biogel® PI UltraTouch® G Surgical Glove tested for use with chemotherapy agents | ||||||||||||||||||||||||||||||||||
| 510(k) clearance | Previously cleared under K081180; subject of this premarket notification to add "tested for use with chemotherapy agents" claim | K140477 | ||||||||||||||||||||||||||||||||||
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | ||||||||||||||||||||||||||||||||||
| Regulation | 21 CFR 878.4460, 21 CFR 878.6250 | 21 CFR 878.4460, 21 CFR 878.6250 | ||||||||||||||||||||||||||||||||||
| Class Name | Surgeon's Gloves | Surgeon's Gloves | ||||||||||||||||||||||||||||||||||
| Classification | Class I | Class I | ||||||||||||||||||||||||||||||||||
| Product Code | KGO, LZC | KGO, LZC | ||||||||||||||||||||||||||||||||||
| Indication for Use | The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. |
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: | Biogel® PI UltraTouch® G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Drug and Concentration Breakthrough detection time in minutes (0.01µg/cm²/mins) Bleomycin 15 mg/ml >240 Busulfan 6 mg/ml >240 Carmustine 3.3 mg/ml 17.3 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20 mg/ml >240 Cytarabine 100 mg/ml >240 Dacarbazine (DTIC) 10 mg/ml >240 | | | | | | | | | | | | | | | | | Drug and Concentration Breakthrough detection time in minutes (0.01µg/cm²/mins) Bleomycin 15 mg/ml >240 Busulfan 6 mg/ml >240 Carmustine 3.3 mg/ml 12.1 Cisplatin 1.0 mg/ml >240 Cyclophosphamide (Cytoxan) 20 mgl/ml >240 Cytarabine 100 mg/ml >240 Dacarbazine (DTIC) 10 mg/ml >240 Doxorubicin Hydrochloride 2 mg/ml >240 | | | | | | | | | | | | | | | | | | |
32
| Doxorubicin
Hydrochloride
| 2 mg/ml | >240 | Ellence 2 mg/ml | >240 |
|---|---|---|---|
| Ellence 2 mg/ml | >240 | Etoposide (Toposar) 20 mg/ml | >240 |
| Etoposide (Toposar) 20 | |||
| mg/ml | >240 | Fludarabine 25 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 | Fluorouracil 50 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 | Idarubicin 1 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 | Ifosfamide 50 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 | Mechlorethamine HCl 1 | |
| mg/ml | >240 | ||
| Mechlorethamine HCl 1 | |||
| mg/ml | >240 | Melphalan 5 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 | Methotrexate 25 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 | Mitomycin C 0.5 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 | Mitoxantrone 2 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 | Paclitaxel (Taxol) 6 | |
| mg/ml | >240 | ||
| Paclitaxel (Taxol) 6 | |||
| mg/ml | >240 | Paraplatin 10 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 | Rituximab 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 | Thiotepa 10 mg/ml | 15.5 |
| Thiotepa 10 mg/ml | 24.1 | Trisenox 0.1 mg/ml | >240 |
| Vincristine Sulfate 1 | |||
| mg/ml | >240 | Vincristine Sulfate 1 | |
| mg/ml | >240 |
33
| Sterilization Method | Irradiation | Irradiation |
|---|---|---|
| Sterility (SAL) | 10-6 | 10-6 |
| Color | Blue | Straw (Natural) |
| Shelf Life | 3-year | 3-year |
| Resistance to Permeation by Chemotherapy Drugs | Meets ASTM D6978-05 (2019) | Meets ASTM D6978-05 |
| Freedom from Holes | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015) requirements | AQL meets 21 CFR 800.20 and ASTM D3577-09 (2015) requirements |
| Powder Residue | Meets requirements of ≤ 2.0 mg/glove for Powder-free designation per ASTM D3577-09 (2015) | Meets requirements of ≤ 2.0 mg/glove for Powder-free designation per ASTM D3577-09 (2015) |
| Dimensions and Physical Properties | Meets ASTM D3577-09 (2015) | Meets ASTM D3577-09 (2015) |
34
Non-clinical Testing
In support of the "tested for use with chemotherapy agents" claim, the permeation of the subject devices by specific chemotherapy drugs was evaluated according to ASTM D6978-05 (2019): Standard Proctice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Clinical Data
Clinical testing was deemed not necessary to support this submission, and therefore, was not performed.
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject devices are as safe, as effective, and perform as well as the legally marketed devices.