FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES by LUCENXIA PRESCIENCE AG

A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)

Device Description

FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for two types of surgical gloves: FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves and FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.

The letter explicitly states that the FDA "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."

This means the device has been cleared based on substantial equivalence to existing predicate devices, not through a study involving acceptance criteria and performance metrics specifically for this device in the way a new, novel AI or diagnostic device would.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not applicable to this type of regulatory submission and clearance.

Here's why and what can be deduced:

A table of acceptance criteria and the reported device performance: Not applicable. The FDA's 510(k) process for devices like surgical gloves primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves performance testing against recognized standards (e.g., ASTM standards for glove integrity, tensile strength, etc.) that the predicate device also met, rather than setting new, specific acceptance criteria for this device's clinical performance in the way an AI diagnostic would. The document does not contain these specific performance details.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of a clinical study for this device as would be seen for an AI diagnostic. Performance testing for gloves typically involves laboratory testing (e.g., for pinholes, physical properties) rather than a clinical trial with a "test set" of patients/cases. The document does not provide details of such testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No "ground truth" establishment in a clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is surgical gloves, not an AI diagnostic algorithm for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is surgical gloves, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for surgical gloves typically relates to meeting physical and biological performance standards (e.g., sterility, barrier integrity, biocompatibility), which are measured objectively, not through human expert consensus on diagnostic images or outcomes data.
The sample size for the training set: Not applicable. No "training set" in the context of machine learning or AI is involved.
How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

Device Name: FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.
Regulation Number: 21 CFR 878.4460
Regulation Name: Surgeon's Glove
Regulatory Class: I
Product Code: KGO
Indications for Use: "A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination."
Clearance Type: 510(k) - Substantial Equivalence to legally marketed predicate devices.
No specific acceptance criteria or performance study results for the device itself are detailed in this regulatory letter. The letter confirms that based on the submitted information (which would include performance data against established standards), the device is substantially equivalent to existing market devices.

To obtain the specific "acceptance criteria" (likely referring to the performance standards met) and the detailed "study" (likely referring to laboratory performance testing) that led to this clearance, one would need to refer to the actual 510(k) submission document (K123629) itself, which is not provided here. The letter only summarizes the outcome of the FDA's review.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Mav 13, 2013

Public Health Service

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

Mr. Robert Hill Regulatory Director Lucenxia Prescience AG Rathausstrasse 7 6341 Baar Switzerland

Re: K123629

Trade/Device Name: FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO · Dated: March 22, 2013 Received: April 5, 2013

Dear Mr. 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. Ilsting 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.

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Page 2 - Mr. Hill

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Seth
urohitu.s.

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): K123629

Device Name:

FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves,

FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.

Indications for Use:

(21 CFR 878.4460)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Do

Claverie

Digitally signed by Elizabeth F. Claverie
DN: c=US, o=U.S. Government,
ou=HHS, ου FDA, ou=People,
0.9.2342.19200300.100.1.1-130005586
4, cn-Elizabeth F. Claverie
Date: 2013.05.10 17:27:42 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

. 510(k) Number: K123629

Page 1 of 1

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).