SensiCare PI and SensiCare PI Micro Surgical Gloves
Device Facts
| Record ID | K193217 |
|---|---|
| Device Name | SensiCare PI and SensiCare PI Micro Surgical Gloves |
| Applicant | Medline Industries, Inc. |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Apr 6, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Indications for Use
The surgeons glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. 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.
Device Story
SensiCare PI and SensiCare PI Micro are disposable synthetic rubber surgical gloves; used by operating room personnel to provide a protective barrier against contamination of surgical wounds. Gloves are tested for permeation resistance against specific chemotherapy drugs per ASTM D6978. Users must avoid use with Carmustine and Thiotepa due to insufficient breakthrough times. Device serves as personal protective equipment in clinical surgical settings.
Clinical Evidence
No clinical data. Bench testing only, specifically permeation testing of chemotherapy drugs per ASTM D6978.
Technological Characteristics
Synthetic rubber surgical gloves. Tested for chemotherapy drug permeation per ASTM D6978. Disposable.
Indications for Use
Indicated for use by operating room personnel as a protective barrier for surgical wounds. Not for use with Carmustine or Thiotepa.
Regulatory Classification
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.
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 6, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K193217
Trade/Device Name: SensiCare PI and SensiCare PI Micro Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: March 6, 2020 Received: March 10, 2020
Dear Jennifer Mason:
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.
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
{1}------------------------------------------------
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,
Image /page/1/Picture/5 description: The image shows the FDA logo. The letters "FDA" are in a large, light blue font. To the right of the letters, there is some text that is cut off. The image is simple and clean.
Elizabeth F. Claverie -S
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) K193217
Device Name
SensiCare PI and SensiCare PI Micro Surgical Gloves
Indications for Use (Describe)
The surgeons glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. 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 following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
SensiCare PI
Bleomycin (15 mg/ml) 240 minutes Busulfan (6 mg/ml) 240 minutes Carboplatin (10.0 mg/ml) 240 minutes Carmustine (3.3 mg/ml) 12.4 minutes (12.4, 14.4, 12.4) Cisplatin (1.0 mg/ml) 240 minutes Cyclophosphamide (Cytoxan) (20 mg/ml) 240 minutes Dacarbazine (DTIC) (10.0 mg/ml) 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) 240 minutes Epirubicin (Ellence) (2 mg/ml) 240 minutes Etoposide (Toposar) (20.0 mg/ml) 240 minutes Fludarabine (25.0 mg/ml) 240 minutes Fluorouracil (50.0 mg/ml) 240 minutes Idarubicin (1.0 mg/ml) 240 minutes Ifosfamide (50.0 mg/ml) 240 minutes Mechlorethamine HCI (1.0 mg/ml) 240 minutes Melphalan (5 mg/ml) 240 minutes Methotrexate (25 mg/ml) 240 minutes Mitomycin (0.5 mg/ml) 240 minutes Mitoxantrone (2.0 mg/ml) 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) 240 minutes Paraplatin (10 mg/ml) 240 minutes Rituximab 10 mg/ml 240 minutes Thiotepa (10.0 mg/ml) 12.4 minutes (12.4, 13.4, 13.2) Vincristine Sulfate (1.0 mg/ml) 240 minutes
Warning: Do not use with Carmustine and Thiotepa
SensiCare PI Micro
Bleomycin 15 mg/ML 240 minutes Busulfan 6 mg/ml 240 minutes Carboplatin 10.0 mg/ml 240 minutes
{3}------------------------------------------------
Carmustine (BCNU) 3.3 mg/ml 12.4 (13.1, 13.8, 12.4) minutes Cisplatin 1.0 mg/ml 240 minutes Cyclophosphamide (Cytoxan) 20 mg/ml 240 minutes Dacarbazine (DTIC) 10.0 mg/ml 240 minutes Doxorubicin Hydrochloride 2.0 mg/ml Epirubicin (Ellence) 2 mg/ml Etoposide (Toposar) 20.0 mg/ml Fludarabine 25.0 mg/ml 240 minutes Fluorouracil 50.0 mg/ml 240 minutes Idarubicin 1.0 mg/ml 240 minutes Ifosfamide 50.0 mg/ml 240 minutes Mechlorethamine HCI 1.0 mg/ml 240 minutes Melphalan 5 mg/ml 240 minutes Methotrexate 25 mg/ml 240 minutes Mitomycin C 0.5 mg/ml 240 minutes Mitoxantrone 2.0 mg/ml 240 minutes Paclitaxel (Taxol) 6.0 mg/ml 240 minutes Paraplatin 10.0 mg/ml 240 minutes Rituximab 10 mg/ml 240 minutes Thiotepa 10.0 mg/ml 22.3 (22.3, 23.9, 23.2) minutes Vincristine Sulfate 1.0 mg/ml 240 minutes
Warning: Do not use with Carmustine and Thiotepa
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
## 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."
