← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K053406

# BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K053406)

_Barriermed Glove Co. · KGO · Jul 5, 2006 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K053406

## Device Facts

- **Applicant:** Barriermed Glove Co.
- **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md)
- **Decision Date:** Jul 5, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4460
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Intended Use

BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

## Device Story

BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove; sterile, single-use, disposable glove. Worn by operating room personnel during surgical procedures. Primary function: provide barrier protection to prevent contamination of surgical wounds. Material: synthetic polyisoprene. Device serves as physical barrier between clinician hands and patient surgical site.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Material: Synthetic polyisoprene. Form factor: Surgical glove. Powder-free. Sterile. Single-use.

## 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2006

Mr. Victor J. Ragucci Chairman & CEO BarrierMed Glove Company 155 Technology Park Lake Mary, Florida 32746

Re: K053406

Trade/Device Name: BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 17, 2006 Received: June 21, 2006

Dear Mr. Ragucci:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Ragucci

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 aqencies. 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); good manufacturing proctice 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sustie H. Michie Davis.

Chíu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement: 3.0

## INDICATIONS FOR USE

| Applicant: | BarrierMed Glove Co.® |
|------------|-----------------------|
|------------|-----------------------|

510(k) Number (if known): *___________________________________________________________________________________________________________________________________________________

Device Name: BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Glove

Indications For Use:

BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shiela A. Mccarthy, MD

nesthesiology, General Hospital, ontrol, Dental Devices

Number 143466

- For a new submission, do **NOT** fill in the 510(k) number.

CONFIDENTIAL

BarrierMed Glove Co.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K053406](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K053406)

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