PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM

K023977 · Starmatrix Sdn Bhd · LYY · Jan 24, 2003 · General Hospital

Device Facts

• Record ID: K023977
• Device Name: PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
• Applicant: Starmatrix Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Story

Pre-powdered latex examination glove; white color; features protein labeling claim of 100 micrograms or less water-soluble protein per gram of glove. Device is disposable; worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Used in clinical or medical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex; pre-powdered; white color. Protein content: 100 micrograms or less water-soluble protein per gram of glove. Regulatory Class I; Product Code LYY.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2003

·Mr. Ngan Boon Seng Director STARMATRIX Sdn. Bhd. 10. Jalan SS 1/26. 47300 Petaling Jaya, Selangor, MALAYSIA

Re: K023977

Trade/Device Name: Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 26, 2002 Received: January 2, 2003

## Dear Mr. Seng:

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. Seng

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/dsma/dsmamain.html

Sincerely yours,

Susan Runner

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

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## 510(k) Number (if known):_K023977

hite color

PRE-POWDERED LATEX EXAMINATION GLOVES Device Name: PROTEIN LABELING CLAIM ( 100 Mg of less

Indications For Use THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGI NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chiu S. Lim
(Division Sign-Off)

Division of Anesthesiology, General Hospital. Infection Control, Dental Devic

510(k) Number: K023927

Prescription Use (Per 21 CFR 801.109) ાર

Over-The-Counter Use

(Optional Formal 1