BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES

K052772 · Barriermed Glove Co. · KGO · Dec 20, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052772
• Device Name: BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES
• Applicant: Barriermed Glove Co.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

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

Device Story

Synthetic polyisoprene orthopedic surgical glove; worn by operating room personnel; provides barrier protection to surgical wounds from contamination. Device functions as a physical barrier; used in surgical settings to maintain sterile field and prevent cross-contamination between patient and clinician.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Synthetic polyisoprene. Form factor: Orthopedic surgical glove. Powder-free. Class I device.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific patient population, age, or gender restrictions stated.

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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Public Health Service

DEC 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052772

Trade/Device Name: BarrierPlus Gold Prtho Powder-Free Synthetic Polyisoprene Orthopedic Surgical Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 6, 2005 Received: December 8, 2005

Dear Mr. Ragucci:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have revious your because some 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 interstate conments, or to thay been reclassified in accordance with the provisions of Amendinents, or to de rouses and Cosmetic Act (Act) that do not require approval of a premarket the Federal F ood, Drag, and Commay, therefore, market the device, subject to the general approvin application (1 he Act. The general controls provisions of the Act include controls provisions of the stration, 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 II your device is classified (See as 10) in a controls. Existing major regulations affecting (1 MA), it may oe subject to Bach adataf Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Sous nouncements 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 mean that in DA mas made a avernand regulations administered by other Federal agencies. of the Act of ally I ederal button and squirements, including, but not limited to: registration r ou intist comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF Rev or 7), and 1007), and ity systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct 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) Frins feter will and in J . The FDA finding of substantial equivalence of your device to a premarket notified.com. - The PDF 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), If you desire specific au rios for Jourse at [phone]. 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 may other general Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Senyte Y. Michael Davis.

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

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1.0 Indications for Use Statement:

## INDICATIONS FOR USE

Applicant: BarrierMed Glove Co.®

510(k) Number (if known): *

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

Indications For Use:

BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic 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 × (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)

Shula T. Murphy D 12/14/65

i

Massachusetts General Hospital,
Lab Control, Central Devices

T fill in the 510(k) number.

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