← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K191860

# Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential (K191860)

_Semperit Technische Produkte Gesellchaft M.B.H. · KGO · Mar 31, 2020 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K191860

## Device Facts

- **Applicant:** Semperit Technische Produkte Gesellchaft M.B.H.
- **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md)
- **Decision Date:** Mar 31, 2020
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 878.4460
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Intended Use

Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

## Device Story

Sterile powder-free synthetic rubber surgeon's glove; single-use disposable device. Worn by operating room personnel during surgical procedures. Primary function: provide barrier protection to prevent contamination of surgical wounds. Device serves as personal protective equipment for clinicians; no electronic or software components.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Synthetic rubber material; powder-free; sterile; single-use; disposable; surgeon's glove form factor.

## 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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March 31, 2020

Semperit Technische Produkte Gesellchaft m.b.H. % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K191860

Trade/Device Name: Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: February 17, 2020 Received: February 26, 2020

Dear Jay Mansour:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K191860

## Device Name

Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential

Indications for Use (Describe)

Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

| 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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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K191860](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K191860)

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