← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K123629

# FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES (K123629)

_Lucenxia Prescience AG · KGO · May 13, 2013 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K123629

## Device Facts

- **Applicant:** Lucenxia Prescience AG
- **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md)
- **Decision Date:** May 13, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4460
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Intended 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. The lubricating or dusting powder used in the glove is excluded.

## Device Story

FINESSIS VIOLET Intense and FINESSIS GREEN Corium are sterile, powder-free surgical gloves made of synthetic polyisoprene. Designed for use by operating room personnel to provide a protective barrier between the wearer and the surgical site, preventing cross-contamination. These gloves function as a physical barrier; they do not involve electronic inputs, algorithms, or software. Used in clinical surgical settings to maintain sterile fields and protect both patient and clinician.

## Clinical Evidence

No clinical data provided; device is a standard surgical glove subject to general controls.

## Technological Characteristics

Material: Synthetic polyisoprene. Form factor: Sterile, powder-free surgical gloves. Energy source: None. Connectivity: None. Sterilization: Sterile.

## Regulatory 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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## 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:

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)

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

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K123629](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K123629)

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