(120 days)
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 Chemical Resistance Data per ASTM D 6978-05
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.
The provided document is an FDA 510(k) clearance letter for a surgical glove. It contains information about the device's name, regulation number, product code, and intended use, specifically highlighting its resistance to certain chemotherapy drugs.
However, the document does NOT contain information about an AI-powered medical device, nor does it detail acceptance criteria, study methodologies for proving device performance (such as test set sample sizes, data provenance, expert qualifications, or ground truth establishment), or MRMC studies.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to the clearance of a physical medical device (surgical gloves) based on material properties and chemical resistance, not an AI or software as a medical device (SaMD) that typically undergoes the type of performance evaluation described in your request.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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§ 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).