QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS

K993271 · Quality Latex Corp. Sdn Bhd · LYY · Dec 2, 1999 · General Hospital

Device Facts

• Record ID: K993271
• Device Name: QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS
• Applicant: Quality Latex Corp. Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purpose and similiar personnel to prevent contamination between health care personnel and the patient.

Device Story

Disposable latex examination glove; intended for use by healthcare personnel to provide a barrier against contamination between patient and examiner. Device features a protein labeling claim of 170 micrograms or less. Used in clinical or medical settings to maintain hygiene and infection control standards.

Clinical Evidence

No clinical data provided; bench testing only regarding protein content labeling.

Technological Characteristics

Latex material; disposable; non-sterile; powdered; protein content labeled at 170 micrograms or less.

Indications for Use

Indicated for use as a disposable medical device by healthcare personnel to prevent cross-contamination between the patient and the 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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Ms. Sharene Wan Quality Latex Products Malaysia Sdn. Bhd. 18-20, Jalan Kilang 2 Jelapang Light Industrial Estate Taman Pertama 30100 Ipoh, Perak, Malaysia

Re : K993271 Trade Name: Quality Latex Powdered Examination Gloves with Protein Labeling Claim of 170 micrograms or less Regulatory Class: I Product Code: LYY Dated: November 5, 1999 Received: November 9, 1999

Dear Ms. Wan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Wan

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regaracion chercless, ":125Panang in other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricio Cucurella / kk

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## QUALITY LATEX PRODUCTS MALAYSIA SDN. BHD. (59087-U)

Factory 1) 19, Persiaran Kilang, Jelapang Light Industrial Estate, Taman Pertama, 30100 Ipoh. Perak. Malaysia. Tel: [phone] Fax: [phone]

- Factory 2) 18 & 20, Jalan Kilang 2, Jelapang Light Industrial Estate, Taman Pertama, 30100 Ipoh. Perak. Malaysia. Tel: [phone] Fax: [phone]
Kg9327i

Attachment 2

## INDICATIONS FOR USE

Applicant : Quality Latex Products Malaysia Sdn. Bhd., 18-20, Jalan Kilang 2, Jelapang Light Industrial Estate, Taman Pertama, 30100 Ipoh, Perak, Malaysia

Device Name : Latex examination gloves (with a protein label claim), Peccaler of Contamp 170 mili grams on less Indications for Use :

A patient examination glove is a disposable device intended for medical purpose and similiar personnel to prevent contamination between health care personnel and the patient.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 OR

Over-The-Conter X

Ction S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _