This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa.

Device Description

This surgeon's glove is a device made of Flexylon.

AI/ML Overview

This document is a 510(k) premarket notification for Finessis Zero Flexylon Powder Free Sterile White Surgical Gloves, tested for use with chemotherapy drugs. It is a Class I device, regulated under 21 CFR 878.4460 (Surgeon's Glove), with product codes KGO and LZC.

The study presented focuses specifically on the glove's resistance to breakthrough by various chemotherapy drugs, as tested according to ASTM D6978-05.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a general sense within the document, but the performance is presented as the breakthrough detection time for each chemotherapy drug. The implicit acceptance criterion for a glove "tested for use with chemotherapy drugs" is that it should demonstrate a reasonable and safe resistance to permeation by these cytotoxic agents. For most drugs, the goal is "No Breakthrough up to 240 min."

Tested Chemotherapy Drug and Concentration per ASTM D6978-05	Acceptance Criteria (Implicit)	Reported Device Performance (Minimum Breakthrough Detection (Specimen 1/2/3) (Minutes))	Meets/Does Not Meet (Relative to 240 min goal)
Drugs with Breakthrough:	> 240 min (ideal)
1 Carmustine (BCNU), 3.3mg/ml (3,300 ppm)	> 240 min (ideal, but a specific threshold for "safety" is not given)	6.9 (9.0, 12.3, 6.9)	Does Not Meet
12 Thiotepa, 10.0 mg/ml (10,000 ppm)	> 240 min (ideal, but a specific threshold for "safety" is not given)	7.6 (9.2, 7.6, 10.0)	Does Not Meet
Drugs with No Breakthrough:	No Breakthrough up to 240 min
2 Cisplatin, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
3 Cyclophosphamide (Cytoxan), 20 mg/ml (20,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
4 Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
5 Doxorubicin Hydrochloride, 2.0mg/ml (2,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
6 Etoposide (Toposar), 20.0 mg/ml (20,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
7 Fluorouracil, 50.0 mg/ml (50,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
8 Ifosfamide, 50.0 mg/ml (50,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
9 Methotrexate, 25 mg/ml (25,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
10 Mitomycin C, 0.5 mg/ml (500 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
11 Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
13 Vincristine Sulfate, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
14 Bleomycin, 15 mg/ml (15,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
15 Busulfan, 6 mg/ml (6,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
16 Carboplatin, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
17 Cytarabine, 100 mg/ml (100,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
18 Daunorubicin, 5 mg/ml (5,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
19 Docetaxel, 10.0 mg/ml (10,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
20 Epirubicin, 2.0 mg/ml (2,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
21 Fludarabine, 25 mg/ml (25,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
22 Ganciclovir, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
23 Gemcitabine (Gemzar), 38 mg/ml (38,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
24 Idarubicin, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
25 Irinotecan, 20.0 mg/ml (20,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
26 Mechlorethamine HCI, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
27 Melphalan, 5.0 mg/ml (5,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
28 Mitoxantrone, 2.0 mg/ml (2,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
29 Oxaliplatin, 2.0 mg/ml (2,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
30 Rituximab, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
31 Trisenox, 0.1 mg/ml (100 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets
32 Vinorelbine, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min	No Breakthrough up to 240 min.	Meets

Note: The FDA's overall determination of substantial equivalence for the device based on all presented information, including this performance data. The "Do Not Use" recommendation for Carmustine and Thiotepa directly addresses the drugs where breakthrough occurred rapidly.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: For each chemotherapy drug, the test set involved 3 specimens of the glove, as indicated by "Specimen 1/2/3" in the "BREAKTHROUGH DETECTION (Specimen 1/2/3) (Minutes)" column.
Data Provenance: The document does not explicitly state the country of origin of the data. However, the testing was conducted per ASTM D6978-05, which is an American Society for Testing and Materials standard. The study seems to be a prospective evaluation, as new gloves were tested against specific chemicals to determine their performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This device is not an AI device or one that requires clinical expert interpretation for its core functionality. The "ground truth" here is the physical property of the glove's resistance to chemical permeation, which is measured objectively through a standardized laboratory test (ASTM D6978-05). Therefore:

Number of Experts: Not applicable in the context of expert human interpretation; the "ground truth" is established by the results of a standardized chemical permeation test.
Qualifications of Experts: Not applicable. The test relies on standardized methodology and instrumentation rather than expert opinion.

4. Adjudication Method for the Test Set

Not applicable. This is a scientific, objective laboratory test. The measurement of breakthrough time for each specimen is a direct outcome of the test procedure, not subject to human adjudication in the sense of reconciling differing opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the goal is often to see how AI assistance improves reader performance. This document describes the chemical resistance of a surgical glove, which is a material property test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a conceptual sense, a "standalone" performance evaluation was done. The device (the surgical glove) was tested without any human "in-the-loop" influencing its chemical resistance or the measurement of that resistance. The test itself measures the intrinsic property of the glove material.

7. The Type of Ground Truth Used

The ground truth used is objective physical measurement data obtained through a standardized laboratory test (ASTM D6978-05). Specifically, it measures the "breakthrough detection time" of various chemotherapy drugs through the glove material.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The performance data is derived from direct physical testing of the glove material.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device and study.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 9, 2018

Lucenxia Prescience AG Robert Hill Regulatory Director Rathausstrasse 7 Baar, CH6341, Switzerland

Re: K173386

Trade/Device Name: Finessis Zero Flexylon Powder Free Sterile White Surgical Gloves, Tested for use with Chemotherapy Drugs

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: March 1, 2018 Received: March 5, 2018

Dear Robert Hill:

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.

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

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801); medical device 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Geeta K. Pamidimukkala -5 for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173386

Device Name

Finessis Zero Flexylon Powder Free Sterile White Surgical gloves Tested for use with Chemotherapy Drugs

Indications for Use (Describe)

This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.

These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa.

Tested Chemotherapy Drugand Concentration per ASTM D6978-05	Minimum BREAKTHROUGH DETECTION(Specimen 1/2/3) (Minutes)
1 Carmustine (BCNU), 3.3mg/ml (3,300 ppm)	6.9 (9.0, 12.3, 6.9)
2 Cisplatin, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min.
3 Cyclophosphamide (Cytoxan), 20 mg/ml (20,000 ppm)	No Breakthrough up to 240 min.
4 Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm)	No Breakthrough up to 240 min.
5 Doxorubicin Hydrochloride, 2.0mg/ml (2,000 ppm)	No Breakthrough up to 240 min.
6 Etoposide (Toposar), 20.0 mg/ml (20,000 ppm)	No Breakthrough up to 240 min.
7 Fluorouracil, 50.0 mg/ml (50,000 ppm)	No Breakthrough up to 240 min.
8 Ifosfamide, 50.0 mg/ml (50,000 ppm)	No Breakthrough up to 240 min.
9 Methotrexate, 25 mg/ml (25,000 ppm)	No Breakthrough up to 240 min.
10 Mitomycin C, 0.5 mg/ml (500 ppm)	No Breakthrough up to 240 min.
11 Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm)	No Breakthrough up to 240 min.
12 Thiotepa, 10.0 mg/ml (10,000 ppm)	7.6 (9.2, 7.6, 10.0)
13 Vincristine Sulfate, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min.
14 Bleomycin, 15 mg/ml (15,000 ppm)	No Breakthrough up to 240 min.
15 Busulfan, 6 mg/ml (6,000 ppm)	No Breakthrough up to 240 min.
16 Carboplatin, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min.
17 Cytarabine, 100 mg/ml (100,000 ppm)	No Breakthrough up to 240 min.
18 Daunorubicin, 5 mg/ml (5,000 ppm)	No Breakthrough up to 240 min.
19 Docetaxel, 10.0 mg/ml (10,000 ppm)	No Breakthrough up to 240 min.
20 Epirubicin, 2.0 mg/ml (2,000 ppm)	No Breakthrough up to 240 min.
21 Fludarabine, 25 mg/ml (25,000 ppm)	No Breakthrough up to 240 min.
22 Ganciclovir, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min.
23 Gemcitabine (Gemzar), 38 mg/ml (38,000 ppm)	No Breakthrough up to 240 min.
24 Idarubicin, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min.
25 Irinotecan, 20.0 mg/ml (20,000 ppm)	No Breakthrough up to 240 min.
26 Mechlorethamine HCI, 1.0 mg/ml (1,000 ppm)	No Breakthrough up to 240 min.
27 Melphalan, 5.0 mg/ml (5,000 ppm)	No Breakthrough up to 240 min.
28 Mitoxantrone, 2.0 mg/ml (2,000 ppm)	No Breakthrough up to 240 min.
29 Oxaliplatin, 2.0 mg/ml (2,000 ppm)	No Breakthrough up to 240 min.
30 Rituximab, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min.
31 Trisenox, 0.1 mg/ml (100 ppm)	No Breakthrough up to 240 min.
32 Vinorelbine, 10 mg/ml (10,000 ppm)	No Breakthrough up to 240 min.

TIME

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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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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Regulation Number and Section

§ 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).