KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

K990526 · Ssn Gloves (M) Sdn Bhd · LYY · Apr 23, 1999 · General Hospital

Device Facts

• Record ID: K990526
• Device Name: KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
• Applicant: Ssn Gloves (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

Device Story

Disposable latex examination glove; worn by healthcare personnel; provides physical barrier to prevent cross-contamination between clinician and patient; powder-free; features protein content labeling claim of 50 micrograms or less; intended for over-the-counter use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable latex examination glove; powder-free; protein content 50 micrograms or less.

Indications for Use

Indicated for use by health care and similar personnel as a disposable protective barrier worn on the hands to prevent cross-contamination between the user and the patient.

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

APR 2 3 1999

Mr. Ang Teck Leong Managing Director SSN Gloves (M) Sdn. Bhd. Lot 147, Jalan Selvadural, Off Jalan Ipoh, 51200 Kuala Lumpur, MALAYSIA

K990526 Re: Kleenhands Powder-Free Latex Examination Trade Name: Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: February 12, 1999 February 19, 1999 Received:

Dear Mr. Ang Teck Leong:

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, Drug, 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 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 (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. ਕੇ 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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.

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## Page 2 - Mr. Ang Teck Leong

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 requlation (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 premarket notification" (21 CFR 807.97). 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,

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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling the louise the 1000mission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

8

| SSN GLOVES (M) SDN. BHD.<br>Applicant: ___________________________________________________________________________________________________________________________________________________________________ | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Number (if known): __ N / A = | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |

Device Name: ................................................................................................................................................................. Indications For Use: CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

> A MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE : DEVICE WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT."

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Chim S. hin

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

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter X

* For a new submission, do NOT fill in the 510(k) number blank.

(Optional Formsi 1-2-96)