POWDERED LATEX SURGICAL GLOVE

K062797 · Beijing Reagent Latex Products Co., Ltd. · KGO · Apr 11, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K062797
• Device Name: POWDERED LATEX SURGICAL GLOVE
• Applicant: Beijing Reagent Latex Products Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Apr 11, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.

Device Story

Disposable natural rubber latex surgeon's glove; features powder coating to facilitate donning; worn on hands by healthcare personnel in surgical settings; acts as protective barrier against infectious materials and contaminants; single-use; non-sterile or sterile (implied by surgeon's glove classification); provides physical barrier to reduce risk of cross-contamination.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Natural rubber latex; includes powder for donning; form factor: surgeon's glove; disposable; regulation 878.4460; product code KGO.

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

Beijing Reagent Latex Products, Company Limited C/O Mr. Ryan Barr Consultant Smith Associates 1676 Village Green, Suite A Crofton, Maryland 21114

APR 1 1 2007

Re: K062797

Trade/Device Name: Powdered Latex Surgeon's Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 21, 2007 Received: March 21, 2007

Dear Mr. Barr:

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 Eederal Register.

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Page 2 - Mr. Barr

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 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); good manufacturing practice 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 vour 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 [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 Division of Small 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 vours.

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): K062797

## Device Name: Powdered Latex Surgeon's Glove

## Indications for Use:

This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.

Prescription use (Part 21 CFR 801 Subpart D) AND/OR

Over - The - Counter Use X (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Shuli R. Murphy-ko

rance Annual Andrew Commend Mosperal, Juon Control, Dennal Devices

2(K) Number: A 062 797