SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE

K062313 · Pt Mahakarya Inti Buana · LYY · Nov 30, 2006 · General Hospital

Device Facts

• Record ID: K062313
• Device Name: SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
• Applicant: Pt Mahakarya Inti Buana
• Product Code: LYY · General Hospital
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination between patient and examiner.

Device Story

Disposable natural rubber latex examination glove; worn on examiner's hand or finger; intended to provide barrier protection against cross-contamination between patient and examiner. Used in medical settings; non-sterile; powder-free. Device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Natural rubber latex. Form factor: Disposable examination glove. State: Powder-free, non-sterile.

Indications for Use

Indicated for use as a disposable, non-sterile, natural rubber latex glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner in medical settings.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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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NOV 3 U 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pt. Mahakarya Inti Buana Mr. V. Nadarajan Manager, Quality Assurance/Regulatory Affairs Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa-20362 SUMUT-INDONESIA

Re: K062313

Trade/Device Name: High Risk Latex Examination Gloves, Powder Free, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 13, 2006 Received: November 16, 2006

Dear Mr. Nadarajan:

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 - Mr. Nadarajan

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 your 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 yours,

Chiu 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

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## Indications for Use

## 510(k) Number (if known): KOGQ313

## Device Name: HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE

Indications For Use: High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination between patient and examiner.

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)

Shulie A. Murphy, M.D.

. of Anesthesiology, General Hospita n Control, Dental Devices

K 062313

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