BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE

K050184 · Regent Medical Americas, LLC · KGO · Mar 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050184
• Device Name: BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
• Applicant: Regent Medical Americas, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Device Story

Poly-Isoprene non-latex sterile powder-free surgeon's glove; disposable barrier device; worn on hands by surgical staff; provides protection against infectious materials and contaminants; intended for surgical environments; non-latex material minimizes risk of latex-related allergic reactions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and material properties.

Technological Characteristics

Material: Poly-Isoprene; sterile; powder-free; form factor: surgeon's glove; disposable.

Indications for Use

Indicated for use as a protective barrier on the hands of healthcare personnel in surgical settings to prevent cross-contamination between the wearer and the patient.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2005

Ms. Kathleen Harris Global Regulatory Manager Regent Medical Americas, LLC 3585 Engineering Drive, Suite 250 Norcross, Georgia 30092

Re: K050184

KU50184
Trade/Device Name: Poly-Isoprene Non-Latex Sterile Powder-Free Surgeon's Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 14, 2005 Received: March 9, 2005

Dear Ms. Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becally of the device is substantially equivalent (for the referenced above and have decemined and to headly marketed predicate devices marketed in indications for use stated in the encreases, 1976, the enactment date of the Medical Device interstate conmittee prior to may 20, 177, as a secondance with the provisions of Affiellents, or to devrees mat have over (Act) that do not require approval of a premarket the Federal Food, Drug, and Ocometto 100 (refere, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the Fiel. "The girling of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (See above) into controls. Existing major regulations affecting (PMA), it may be subject to Sach addin Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sode 77 received.
addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Harris

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S issualled on a subscurity with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA nas made a decemination that your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations and mot limited to: registration of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and manufacturing prectice You must comply with an the Act 3 requirements integral manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820); and i and listing (21 CPK Part 807), laboling (21 CFR Parvalson (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act);
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) i his letter will anow you to begin matically your as ial equivalence of your device to a premarket notification. THCTDA mixing of basication 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 advice for your 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 other general meetirs, International and Consumer Assistance at its toll-free Division of 0.638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chin Lin, Ph.D.

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

Enclosure

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## Indications for Use

510(k) Number (if known): K050184

Device Name: Poly-Isoprene non-latex sterile powder-free surgeon's glove

Indications For Use:

A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Sign-O)
Jsion of Anesthesiology, General Hospilat,
action Controi, Dental Devices

) Number: A 150 184