STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING

K031670 · P.T. Saptindo Surgica · KGO · Sep 23, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031670
• Device Name: STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING
• Applicant: P.T. Saptindo Surgica
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Story

Sterile powder-free latex surgical gloves with polymer coating; worn by healthcare personnel to provide barrier protection; prevents cross-contamination between patient and clinician; used in clinical/surgical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Sterile, powder-free natural rubber latex surgical gloves; polymer-coated; Class I device; product code KGO.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier 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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Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Widagdo Gondowardoyo President Director P.T. Saptindo Surgica J.L. Raya Serang Km 65 Cikande, Serang 42186 Jawa Barat INDONESIA

Re: K031670

Trade/Device Name: Sterile Powder Free Latex Surgical Gloves with Polymer Coating Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 24, 2003 Received: June 26, 2003

Dear Dr. Gondowardoyo:

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 – Dr. Gondowardoyo

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/dsma/dsmamain.html

Sincerely yours,

Susan Dunne

Susan Runner, DDS, MA Interim 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

K031670

PT Saptindo Surgica Applicant:

510 (k) number (if known):

Sterile Powder Free Latex Surgical Gloves with Polymer Coating Device Name:

Indications For Use

" A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient."

Chris Lin

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Device

510(k) Number: K031670

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

Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96)

OR

Over - The - Counter _________________________________________________________________________________________________________________________________________________________