LATEX EXAMINATION POWDERED GLOVES

K993386 · Great Glove Sdn Bhd · LYY · Dec 20, 1999 · General Hospital

Device Facts

• Record ID: K993386
• Device Name: LATEX EXAMINATION POWDERED GLOVES
• Applicant: Great Glove Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Latex Examination powdered glove is a disposable device intended for Medical purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Device Story

Latex examination powdered glove; disposable; worn on examiner's hand. Function: barrier protection to prevent contamination between patient and examiner. Used in clinical settings by healthcare professionals. Benefit: reduces risk of cross-contamination during medical examinations.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; powdered; disposable; examination glove form factor.

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

DEC 2 0 1999

Mr. K.M. Lee General Manager Great Glove Sdn. Bhd. 24, Jalan Raja Mokhtar Dua 42200 Kapar, Selangor D.E., Malaysia

Re: K993386 Latex Examination Powdered Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: October 5, 1999 Received: October 8, 1999

Dear Mr. Lee:

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, qood manufacturing practice, labeling, and prohibitions aqainst 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. A 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 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

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Page 2 - Mr. Lee

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 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,

Susan Punner

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 claims in the entire the 510(k) submission must support and agree wills the Indications for Use statement.

1993386

## INDICATIONS FOR USE

| Applicant: | GREAT GLOVE SDN. BHD. |
|---------------------------|-----------------------------------|
| 510(k) Number (if known): | |
| Device Name: | LATEX EXAMINATION POWDERED GLOVES |

Indications For Use:

Latex Examination powdered glove is a disposable device intended for Medical purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

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

Concurrence of CDRH Ottice of Device Evaluation (ODE)

Jany Summor for Chui Leri RD
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -

Prescription Use Per 21 CFR 801.109 ()[{{

Over-The-Counter

(Optional Pornat 1-2-5

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

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