BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES

K990710 · Barriermed Glove Co. · KGO · May 20, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990710
• Device Name: BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
• Applicant: Barriermed Glove Co.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens.

Device Story

BarrierPlus™ Synthetic Powder-Free Surgical Gloves are sterile, single-use protective barriers. Worn by operating room personnel during invasive and non-invasive procedures; primary function is to prevent cross-contamination between the surgical wound and the healthcare provider. Protects against blood-borne pathogens. Device is a physical barrier; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic material, powder-free, sterile, surgical glove form factor. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by operating room personnel in sterile hospital or healthcare environments during invasive surgical procedures and non-invasive activities requiring sterility to protect surgical wounds from contamination and users from blood-borne pathogens.

Regulatory Classification

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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MAY 20 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carlo Poncipe Senior Project Manager BarrierMed Glove Company 2500 West Lake Mary Boulevard Lake Mary, Florida 32746

Re : K990710 Trade Name: BarrierPlus™ Synthetic Powder-Free Surgical Gloves Regulatory Class: I Product Code: KGO Dated: March 2, 1999 Received: March 4, 1999

Dear Mr. Poncipe:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Poncipe

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE 3.0

Applicant: BarrierMed Glove Co. 510(k) Number (if known):* Device Name: Synthetic Powder-Free Surgical Gloves

Indications For Use:

These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use | | OR | Over-The-Counter | X |
|--------------------|--|----|------------------|---|
| Per 21 CFR 801.109 | | | | |

* For a new submission, do NOT fill in the 510(k) number blank (optional format1-2-96)

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number J

BarrierMed Glove Co.

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