(390 days)
Not Found
No
The document describes surgical gloves and their testing for chemotherapy drug permeation. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a surgical glove intended to provide a barrier against contaminants, not to treat or cure a disease or condition.
No
The device description clearly states that the devices are disposable surgical gloves intended to provide a barrier against infectious material and contaminants, not to diagnose medical conditions.
No
The device description clearly states the device is a physical product (surgical gloves) made from synthetic materials. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: The described devices are surgical gloves. Their primary function is to provide a physical barrier on the hands of the user to protect against contaminants and infectious material during medical procedures. They are used on the body (or rather, on the hands of the user).
- Intended Use: The intended use clearly states they are "intended to be worn on the hands... to provide barrier against potentially infectious material, and other contaminants." This is a barrier function, not a diagnostic function.
- Testing: While the gloves were tested for permeation by chemotherapy drugs, this testing is to assess their barrier performance against these substances, not to diagnose or provide information about a patient's health.
Therefore, based on the provided information, these surgical gloves do not fit the definition or function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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:
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:
The Biogel® PI UltraTouch™ G and the Biogel® Skinsense® surgical gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infections 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:
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
The subject devices are disposable powder-free surgical gloves that are supplied sterile and are not made from natural rubber latex. They have been tested for use with chemotherapy agents. The Biogel® PI UltraTouch™ G surgical gloves are made from synthetic polyisoprene material and the Biogel® SkinSense® surgical gloves are made from synthetic polychloroprene material. The gloves have been previously 510(k) cleared through K050184 and K053102 respectively.
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
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The gloves were tested according to ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs at the concentrations that are known to be common in standard clinical care.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Chemotherapy Drug Permeation Testing:
The gloves were tested according to ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs at the concentrations that are known to be common in standard clinical care.
Tables of breakthrough detection times were provided for Biogel® Skinsense® Surgical Glove and Biogel® PI UltraTouch™ G Surgical Glove for various chemotherapy drugs.
For Biogel® Skinsense® Surgical Glove: Carmustine (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. All other listed drugs had a breakthrough detection time of >240 minutes.
For Biogel® PI UltraTouch™ G Surgical Glove: 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. All other listed drugs had a breakthrough detection time of >240 minutes.
Also tested for ASTM D3577, 21 CFR 800.20 for Freedom from Holes, and powder residual meet 2.0 mg/glove for Powder-free designation.
Biocompatibility tests (Primary Skin Irritation and Sensitization Guinea pig closed-patch per ISO 10993-10) showed the device is not an irritant or sensitizer. Sterilization method: Gamma Radiation with SAL of 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Carmustine (3.3 mg/ml) breakthrough detection time: 60.2 minutes for Biogel Skinsense, 12.1 minutes for Biogel PI UltraTouch G.
Thiotepa (10 mg/ml) breakthrough detection time: 75.8 minutes for Biogel Skinsense, 15.5 minutes for Biogel PI UltraTouch G.
For most other chemotherapy drugs, the breakthrough detection time was >240 minutes for both types of gloves.
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.
Biogel® PI (polyisoprene) Surgical Gloves (K050184), Biogel® Skinsense® (polychloroprene) Surgical Glove (K053102), Cardinal Health Esteem Polyisoprene Powder Free Surgical Glove (K110272), Cardinal Health (Allegance) Dermaprene Surgical Glove (K013302)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
Mölnlycke Health Care US, LLC Ms. Megan Bevill Regulatory Affairs Manager 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092
Re: K140477
Trade/Device Name: Biogel® PI Ultra Touch™ G Surgical Glove tested for use with chemotherapy agents, Biogel® SkinSense® Surgical Glove tested for use with chemotherapy agents
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: I Product Code: KGO, LZC Dated: February 18, 2015 Received: February 20, 2015
Dear Ms. Bevill:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140477
Device Name
Biogel® Skinsense® Surgical Glove tested for use with chemotherapy agents
Indications for Use (Describe)
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:
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 201. Select One) | General Use/Testing (21 CFR 201. Select One) |
|---|---|
__ 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
| Biogel® Skinsense® | |
|---|---|
| Drug and Concentration | Breakthrough Detection Time in Minutes |
| (0.01 µg/cm²/ minutes) | |
| 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 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 | 75.8 |
| 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 compare 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.
4
Indications for Use
510(k) Number (if known) K140477
Device Name
Biogel® PI UltraTouch™ G Surgical Glove tested for use with chemotherapy agents
Indications for Use (Describe)
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:
| Type of Use (Select one or both, as applicable) | ☐ Remediation Use (Part 21 CFR 201.5(a) and (b))☑ Same-Time Contact Use (21 CFR 201.5(a) and (c)) | ☐ Remediation Use (Part 21 CFR 201.5(a) and (b)) | ☑ Same-Time Contact Use (21 CFR 201.5(a) and (c)) |
|---|---|---|---|
| ☐ Remediation Use (Part 21 CFR 201.5(a) and (b)) | ☑ Same-Time Contact Use (21 CFR 201.5(a) and (c)) |
_ | 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
| Biogel® PI UltraTouch™ G | |
|---|---|
| Drug and Concentration | Breakthrough Detection Time in Minutes |
| (0.01 $\mu$ g/cm2/ minutes) | |
| 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 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 | 15.5 |
| 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 compare to other chemotherapy drugs:
- י 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
6
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Date Prepared: | March 20, 2015 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Megan Bevill |
| Regulatory Affairs Manager | |
| Tel: 470-375-0049 | |
| Fax: 678-245-7746 | |
| email: megan.bevill@molnlycke.com | |
| Trade/Proprietary Names: | Biogel® PI Ultra Touch™ G Surgical Glove (ref. code 421) tested for use with chemotherapy agents |
| Biogel® Skinsense® Surgical Glove (ref. code 314) tested for use with chemotherapy agents | |
| Common Name: | Surgeon's Glove |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 878.4460 |
| Product Code: | KGO [primary] |
| LZC | |
| Predicate Device Name(s): | Biogel® PI (polyisoprene) Surgical Gloves (K050184) |
| Biogel® Skinsense® (polychloroprene) Surgical Glove (K053102) | |
| Cardinal Health Esteem Polyisoprene Powder Free Surgical Glove (K110272) | |
| Cardinal Health (Allegance) Dermaprene Surgical Glove (K013302) |
Description of Device:
The subject devices are disposable powder-free surgical gloves that are supplied sterile and are not made from natural rubber latex. They have been tested for use with chemotherapy agents. The
7
Biogel® PI UltraTouch™ G surgical gloves are made from synthetic polyisoprene material and the Biogel® SkinSense® surgical gloves are made from synthetic polychloroprene material. The gloves have been previously 510(k) cleared through K050184 and K053102 respectively.
Reason for 510(k) Submission:
The addition of the intended use claim 'Tested for use with Chemotherapy Drugs'.
Intended Use/Indication for Use:
The Biogel® PI UltraTouch™ G and the Biogel® Skinsense® surgical gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infections 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
(0.01 µg/cm²/ minutes) | |
|----------------------------------------|------------------------------------------------------------------|--------------------|
| | Biogel® UltraTouch™ G | Biogel® Skinsense® |
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | 12.1 | 60.2 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan)
20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride
2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | 15.5 | 75.8 |
| Trisenox 0.1 mg/ml | >240 | >240 |
8
| Vincristine Sulfate 1 mg/ml | >240 | SOAC
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 |
|-----------------------------|------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
Please note that Carmustine (3.3 mg/ml) and Thiotepa (10 mg/ml) have much lower permeation times compare to other chemotherapy drugs:
For Biogel® PI UltraTouch ™ G surgical glove:
- l 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
For Biogel® Skinsense® surgical glove:
- 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.
Technological Characteristics and Performance:
The subject devices have been previously 510(k) cleared and have not undergone any modification in design or material. From a technological perspective, the subject devices remain substantially equivalent to the devices previously cleared though 510(k) K050184 and K053102. A tabular summary of features, technological characteristics and intended use is provided that includes a comparison between the subject devices and original devices cleared previously.
9
| Summary of features and technological characteristics of the devices compared to the predicate devices | ||||
|---|---|---|---|---|
| Feature | Subject Devices, | |||
| 510(k) K140477 | K050184 and K053102 | K110272 | K013302 | |
| Feature | Biogel® PI UltraTouch™ G | |||
| tested for use with | ||||
| chemotherapy agents | ||||
| Biogel® Skinsense® tested for | ||||
| use with chemotherapy agents | Biogel® PI surgical gloves | |||
| (K050184) | ||||
| Biogel® Skinsense® surgical | ||||
| gloves (K053102) | Sterile Polyisoprene | |||
| Powder-Free Surgical | ||||
| Gloves Tested for Use with | ||||
| Chemotherapy Drugs | Duraprene Sterile | |||
| Synthetic Powder-Free | ||||
| Surgical Gloves Tested for | ||||
| Use with Chemotherapy | ||||
| Drugs Labeling Claim | ||||
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | Cardinal Health | Allegiance Healthcare |
| Corporation | ||||
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 |
| Common Name | Surgeon's Glove | Surgeon's Glove | Surgeon's Glove | Surgeon's Glove |
| Regulatory Classification | Class I | Class I | Class I | Class I |
| Product Code | KGO (primary product code) | |||
| LZC (subsequent product code) | KGO (primary product code) | KGO | ||
| LZC | KGO | |||
| Material Composition | Biogel® PI UltraTouch™ G | |||
| tested for use with | ||||
| chemotherapy agents | ||||
| Synthetic Polyisoprene | ||||
| Biogel® Skinsense® tested for | ||||
| use with chemotherapy agents | ||||
| Synthetic Polychloroprene | Biogel® PI | |||
| Synthetic Polyisoprene | ||||
| Biogel® Skinsense® | ||||
| Synthetic Polychloroprene | Synthetic polyisoprene | Neoprene | ||
| (polychloroprene) | ||||
| Design | Sterile, Single Use, Powder- | |||
| free, | ||||
| Hand-specific, beaded cuff | Sterile, Single Use, Powder- | |||
| free, Hand-specific, beaded | ||||
| cuff | Sterile, Single Use, | |||
| Powder-free, Hand- | ||||
| specific, Independent | ||||
| Thumb, beaded cuff, | ||||
| lubricated | Sterile, Powder-free | |||
| Summary of features and technological characteristics of the devices compared to the predicate devices | ||||
| Subject Devices, | ||||
| 510(k) K140477 | K050184 and K053102 | K110272 | K013302 | |
| Intended Use | Surgeon's glove that is intended | |||
| to be worn on the hands, usually | ||||
| in surgical setting, to provide | ||||
| barrier against potentially | ||||
| infectious material, and other | ||||
| contaminants. |
In addition, 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. Gloves
may be worn when
administering chemotherapy. *
(*see note at bottom of table) | Surgeon's glove that is
intended to be worn on the
hands, usually in surgical
setting, to provide barrier
against potentially infectious
material, and other
contaminants. | Powder-free surgeon's
glove | Intended for use in
environments within
hospitals and other
healthcare facilities. The
gloves are appropriate for
use during invasive and
non-invasive medical
procedures requiring
sterility. They are intended
to be worn by operating
room personnel to protect a
surgical wound from
contamination. |
| Dimensions & Physical
Properties | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 | Not specified in 510(k)
summary |
| Freedom from Holes | AQL meets 21 CFR 800.20 &
ASTM D3577 requirements | AQL meets 21 CFR 800.20 &
ASTM D3577 requirements | AQL meets 21 CFR 800.20
& ASTM F3577
requirements | AQL exceeds 21 CFR
800.21 & ASTM D3577
requirements (AQL = 1.5) |
| Powder Residual | Meets requirements of $≤$ 2.0
mg/glove for Powder-free
designation per ASTM D3577 | Meets requirements of $≤$ 2.0
mg/glove for Powder-free
designation per ASTM D3577 | Meets requirements of $≤$
2.0 mg/glove for Powder-
free designation per ASTM
D3577 | Meets requirements of $≤$
2.0 mg/glove for Powder-
free designation per ASTM
D6124-00 |
| Biocompatibility | | | | |
| Summary of features and technological characteristics of the devices compared to the predicate devices | | | | |
| | Subject Devices,
510(k) K140477 | K050184 and K053102 | K110272 | K013302 |
| Primary Skin Irritation | Under the conditions of the
study (per ISO 10993-10), the
device is not an irritant | Meets ISO 10993-10
requirement | Gloves are non-irritating | Gloves show no
intracutaneous reactivity |
| Sensitization
(Guinea pig closed-
patch) | Under the conditions of the
study (per ISO 10993-10), the
device is not a sensitizer | Meets ISO 10993-10
requirement | Gloves do not display any
potential for sensitization | Gloves do not display any
potential for irritation |
| Sterilization method | Gamma Radiation | Gamma Radiation | Not specified in 510(k)
summary | Not specified in 510(k)
summary |
| Sterility Assurance
Level (SAL) | 10-6 SAL | 10-6 SAL | Not specified in 510(k)
summary | Not specified in 510(k)
summary |
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*note: The addition of the intended use claim "Tested for use with chemotherapy drugs' is supported by permeation breakthrough times of chemotherapy agents. Minimum breakthrough times were determined for the subject devices using a wide range of chemotherapy drugs at the concentrations that are known to be commons are. Comparisons are made between the subject devices and predicate devices that are currently 510(k) cleared and marketed for this specific use.
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Chemotherapy Drug Permeation Testing:
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The gloves were tested according to ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs at the concentrations that are known to be common in standard clinical care. A tabular summary of the minimum breakthrough times is provided on the following next page. The summary provides a comparison of minimum breakthrough times between the subject devices and predicate devices that are currently 510(k) and marketed for use with Chemotherapy Drugs. These predicate devices include the Cardinal Health Esteem and Duraprene Surgical Gloves cleared through K110272 and K013302.
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| Minimum breakthrough time in minutes (0.01 µg/cm2/minute) | ||||
|---|---|---|---|---|
| Biogel® PI | ||||
| UltraTouch™ G | Biogel® | |||
| Skinsense® | Cardinal | |||
| Esteem | ||||
| K110272 | Cardinal | |||
| Duraprene | ||||
| K013302 | ||||
| Bleomycin 15 mg/ml | >240 | >240 | >240 | not tested |
| Busulfan 6 mg/ml | >240 | >240 | >240 | not tested |
| Carmustine 3.3 mg/ml | 12.1 | 60.2 | 0.37 | 0.2 |
| Cisplatin 1.0 gm/ml | >240 | >240 | >240 | >240 |
| Cyclophosphamide 20 | ||||
| mg/ml | >240 | >240 | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 | >240 | not tested |
| Dacarbazine 10 mg/ml | >240 | >240 | >240 | not tested |
| Doxorubicin | ||||
| Hydrochloride | ||||
| 2 mg/ml | >240 | >240 | >240 | >240 |
| Ellence 25 mg/ml | not tested | not tested | >240 | not tested |
| Ellence 2 mg/ml | >240 | unavailable | >240 | not tested |
| Etoposide 20 mg/ml | >240 | >240 | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 | >240 | not tested |
| Fluorouracil 50 mg/ml | >240 | >240 | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 | >240 | not tested |
| Ifosfamide 50 mg/ml | >240 | >240 | >240 | not tested |
| Mechlorethamine HCl | ||||
| 1 mg/ml | >240 | >240 | >240 | not tested |
| Melphalan 5 mg/ml | >240 | >240 | >240 | not tested |
| Methotrexate 25 mg/ml | >240 | >240 | >240 | >240 |
| Mitomycin 0.5 mg/ml | >240 | >240 | >240 | not tested |
| Mitoxantrone 2 mg/ml | >240 | >240 | >240 | not tested |
| Paclitaxel 6 mg/ml | >240 | >240 | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 | >240 | not tested |
| Rituximab 10 mg/ml | >240 | >240 | >240 | not tested |
| Thiotepa 10 mg/ml | 15.5 | 75.8 | 0.44 | 82.2 |
| Trisenox 0.1 mg/ml | >240 | not tested | >240 | not tested |
| Vincristine Sulfate 1 | ||||
| mg/ml | >240 | >240 | >240 | >240 |
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Conclusion:
The subject devices are substantially equivalent to the Biogel® Surgical Gloves previously 510(k) cleared (K050184 and K053102) with respect to design, technological characteristics and intended use. The subject devices are substantially equivalent to the Cardinal Health Power-free Surgical Gloves (K110272 and K013302) with respect to the addition of the chemotherapy use labeling and the permeation testing method and results for supporting such use. Clinical data was not required to demonstrate substantial equivalence. In conclusion, the subject Biogel® PI UltraTouch™ G and Biogel® Skinsense® surgical gloves are as safe, as effective, and perform as well as the predicate devices cleared under K050184 and K053102.