(233 days)
This surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
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This document is an FDA 510(k) Premarket Notification for a surgical glove, not an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study design for AI evaluation (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details), and adjudication methods is not applicable to this document.
The document describes the performance of the SensiCare PI Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera, specifically its resistance to chemotherapy drug permeation.
Here's how the provided information relates to the "device" (the surgical glove) under review:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for these gloves, as relevant to the provided data, would implicitly be that the breakthrough detection time (permeation time) for chemotherapy drugs should be sufficiently long to provide protection, ideally exceeding 240 minutes for most drugs. The device performance is reported directly in the tables on pages 3 and 5.
Acceptance Criteria & Reported Performance for SensiCare PI Sterile Surgical Gloves (Natural and Green Colors)
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implied) | Reported Performance (Breakthrough Detection Time in Minutes) - Natural Color (Page 3) | Reported Performance (Breakthrough Detection Time in Minutes) - Green Color (Page 5) |
|---|---|---|---|---|
| Bleomycin | 15 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Busulfan | 6 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Carboplatin | 10.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml | Longer time preferred | 22.5 (23.4, 23.8, 22.5) minutes | 13.7 (14.4, 14.4, 13.7) minutes |
| Cisplatin | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Epirubicin (Ellence) | 2 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Fludarabine | 25.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Idarubicin | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Ifosfamide | 50.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Mechlorethamine HCI | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Melphalan | 5 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Methotrexate | 25 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Mitomycin C | 0.5 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Mitoxantrone | 2.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Paraplatin | 10 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Rituximab | 10 mg/ml | >240 minutes | >240 minutes | >240 minutes |
| Thiotepa | 10.0 mg/ml | Longer time preferred | 24.4 (25.3, 24.4, 25.6) minutes | 13.8 (13.8, 16.4, 14.8) minutes |
| Vincristine Sulfate | 1.0 mg/ml | >240 minutes | >240 minutes | >240 minutes |
Warning: The document explicitly states "Warning: Do not use with Carmustine and Thiotepa" for both glove types due to their limited breakthrough times.
The remaining points (2-9) are not applicable as this is not an AI/software device:
- Sample sized used for the test set and the data provenance: Not an AI study. This relates to physical testing of gloves for chemical permeation. The standard for such testing would typically involve multiple glove samples to ensure reproducibility and statistical validity, but the specific sample size for each drug test is not provided in this regulatory letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established through laboratory testing, not expert consensus (e.g., using analytical chemistry methods to detect drug breakthrough).
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for evaluating changes in human reader performance with AI.
- If a standalone was done: Not applicable. This refers to algorithm-only performance.
- The type of ground truth used: For these gloves, the "ground truth" is the measured breakthrough time of the chemotherapy drugs through the glove material, determined by standardized laboratory methods (e.g., ASTM F739 or similar).
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory letter for a medical device (surgical gloves) and details its performance against specific chemical permeation, which are the relevant "acceptance criteria" and "study results" for this type of product. The questions posed are designed for AI-driven medical devices and thus, are largely not relevant to this document.
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September 11, 2020 Medline Industries, Inc Jennifer Mason Senior Regulatory Affairs Specialist Three Lake Drive Northfield, Illinois 60093
Re: K191915
Trade/Device Name: SensiCare Sterile Power-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs) - Natural and Green Colors Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC
Dear Jennifer Mason:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 6, 2020. Specifically, FDA is updating this SE Letter (e.g. Incorrect Contact information) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Vacant, OHT4: Office of Surgical and Infection Control Devices, (301) 796-6298, Elizabeth.Claverie@fda.hhs.gov.
Sincerely,
Ryan Ortega -S
For 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
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March 6, 2020
Medicine Industries, Inc Jennifer Mason Senior Regulatory Affairs Specialist Three Lake Drive Northfield, Illinois 60093
Re: K191915
Trade/Device Name: SensiCare Sterile Power-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs) - Natural and Green Colors Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: February 3, 2020 Received: February 4, 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
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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/5 description: The image shows the text "Elizabeth F. Claverie -S". The text is arranged in two lines, with "Elizabeth F." on the first line and "Claverie -S" on the second line. The font is sans-serif and the color is black. There is a logo on the left side of the text.
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
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Indications for Use
510(k) Number (if known) K191915
Device Name
SensiCare PI Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs) - Natural Color
Indications for Use (Describe)
This surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemicals have been tested with these gloves
| Bleomycin | 15 mg/ml >240 minutes |
|---|---|
| Busulfan | 6 mg/ml >240 minutes |
| Carboplatin | 10.0 mg/ml >240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml 22.5 (23.4, 23.8, 22.5) 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 >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 C | 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 24.4 (25.3, 24.4, 25.6) 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.
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Indications for Use
510(k) Number (if known) K191915
Device Name
SensiCare PI Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs) - Green Color
Indications for Use (Describe)
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemicals have been tested with these gloves
| Bleomycin | 15 mg/ml >240 minutes |
|---|---|
| Busulfan | 6 mg/ml >240 minutes |
| Carboplatin | 10.0 mg/ml >240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml 13.7 (14.4, 14.4, 13.7) 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 >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 C | 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 13.8 (13.8, 16.4, 14.8) 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.
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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."
§ 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).