Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

K162852 · Lucenxia Prescience AG · KGO · Feb 8, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162852
• Device Name: Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
• Applicant: Lucenxia Prescience AG
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Feb 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Indications for Use

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.

Device Story

Finessis Zero Chemo Flexylon surgical glove; sterile, powder-free, white. Material: Flexylon (styrene-ethylene/butylene-styrene, SEBS). Intended for use by operating room personnel to protect surgical wounds from contamination. Provides barrier protection during handling of chemotherapy drugs. Tested for chemical resistance per ASTM D 6978-05. Contraindicated for use with Carmustine and Thiotepa due to insufficient breakthrough detection times. Device serves as a physical barrier; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only, specifically chemical resistance testing per ASTM D 6978-05 for chemotherapy drug breakthrough times.

Technological Characteristics

Material: Flexylon (styrene-ethylene/butylene-styrene, SEBS). Form factor: Sterile, powder-free, white surgical glove. Chemical resistance tested per ASTM D 6978-05. No electronic, software, or energy-based components.

Indications for Use

Indicated for use by operating room personnel as a protective barrier for surgical wounds. Tested for use with chemotherapy drugs; contraindicated 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)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 8, 2017

Lucenxia Prescience Ag Robert Hill Regulatory Director Rathausstrasse 7 Baar, 6341 CH

Re: K162852

Trade/Device Name: Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: January 11, 2017 Received: January 11, 2017

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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Division 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162852

## Device Name

FINESSIS ZERO CHEMO Flexylon Powder Free Sterile White Surgical Gloves

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.

Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.

These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa Chemical Resistance Data per ASTM D 6978-05

| Drug | Minimum Breakthrough Detection Time (minutes) |
|--------------------------------------------------|-----------------------------------------------|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 15.3 |
| Cisplatin 1.0 mg/ml (1,000 ppm) | 240 |
| Cyclophosphamide (cytoxan) 20 mg/ml (20,000 ppm) | 240 |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000) | 240 |
| Doxorubincin Hydrochloride 2.0 mg/ml (2,000 ppm) | 240 |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | 240 |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | 240 |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | 240 |
| Methotrexate 25 mg/ml (25,000 ppm) | 240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | 240 |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | 240 |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 15.8 |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | 240 |

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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