(69 days)
Not Found
Not Found
No
The 510(k) summary describes a standard surgical glove and its testing for chemotherapy drug permeation, with no mention of AI or ML.
No
The device, a surgeon's glove, is intended to protect a surgical wound from contamination and for use with chemotherapy drugs to prevent permeation, not to treat or cure a disease or condition.
No
Explanation: The device, a surgeon's glove, is intended to protect a surgical wound from contamination and for use with chemotherapy drugs, not for diagnosing any medical condition.
No
The device is described as a physical, disposable glove made of synthetic rubber latex, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a protective barrier for operating room personnel and surgical wounds. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: While "Not Found" is listed, the intended use and performance testing described point to a physical barrier device.
- Performance Studies: The performance studies focus on the glove's ability to resist permeation by chemotherapy drugs. This is a test of the glove's material properties and barrier function, not a diagnostic test.
- Key Metrics: The key metrics are related to the breakthrough time of chemotherapy drugs, which measures the glove's barrier effectiveness.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This surgeon's glove does not perform such a function.
N/A
Intended Use / Indications for Use
The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use 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 Bleomycin (15mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml) >240 minutes Carmustine (3.3 mg/ml) 24.3 minutes (24.3, 24.6, 25.5) Cisplatin (1.0 mg/ml) >240 minutes Cyclohosphamide (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 WARNING: DO NOT USE WITH CARMUSTINE. Methotrexate (25 mg/ml) >240 minutes CAUTION: Testing showed a minimum Mitomycin C (0.5 mg/ml) >240 minutes breakthrough time of 32.6 minutes for Thiotepa 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) 32.6 minutes (32.6, 34.7, 45.4) Vincristine Sulfate (1.0 mg/ml) >240 minutes
Product codes
LZC, KGO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 9, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60030
Re: K201829
Trade/Device Name: SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, KGO Dated: June 29, 2020 Received: July 2, 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.
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 (OS) 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.
Elizabeth F. Claverie-Williams, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use 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
Bleomycin (15mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml) >240 minutes Carmustine (3.3 mg/ml) 24.3 minutes (24.3, 24.6, 25.5) Cisplatin (1.0 mg/ml) >240 minutes Cyclohosphamide (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 WARNING: DO NOT USE WITH CARMUSTINE. Methotrexate (25 mg/ml) >240 minutes CAUTION: Testing showed a minimum Mitomycin C (0.5 mg/ml) >240 minutes breakthrough time of 32.6 minutes for Thiotepa 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) 32.6 minutes (32.6, 34.7, 45.4) Vincristine Sulfate (1.0 mg/ml) >240 minutes
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)
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