LATEX EXAMINATION GLOVES (POWDER FREE)

K991689 · Usg Healthguard Sdn Bhd · LYY · Jun 24, 1999 · General Hospital

Device Facts

• Record ID: K991689
• Device Name: LATEX EXAMINATION GLOVES (POWDER FREE)
• Applicant: Usg Healthguard Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jun 24, 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 that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable latex patient examination glove; worn by healthcare examiners on hands or fingers; functions as a protective barrier to prevent cross-contamination between patient and examiner; intended for medical use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Latex material; powder-free; disposable; form-fitting glove design; Class I medical device.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners on hands or fingers 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

JUN 2 4 1999

Mr. Toh Chee Yeong General Manager USG HealthGuard Sdn. Bhd. (Company No. 183887-X) Lot 2756, Jalan Kempas Lama (Off 8 Miles, Jalan Skudai) 81300 Tampoi Johor Bahru, Johor MALAYSIA

K991689 Re : Latex Examination Gloves (Powder Free) Trade Name: Regulatory Class: I Product Code: LYY May 3, 1999 Dated: Received: May 18, 1999

Dear Mr. Toh Chee Yeong:

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 able Beaced in the enough, 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, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Toh Chee Yeong

this response to your premarket notification Please note: 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 requlations.

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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## Indications For Use Statement.

| 510 (K) Number (if known) | K991689 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Powder-Free, Latex Patient Examination Gloves |
| Indication For Use | A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qian S. Lin

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

Prescription Use (Per 21 CFR 801.109)

..

OR

Over-The-Counter Use _ (Optional Format 1-2-96)