PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER

K992117 · Pamitex Industries Sdn Bhd · LYY · Sep 27, 1999 · General Hospital

Device Facts

• Record ID: K992117
• Device Name: PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
• Applicant: Pamitex Industries Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Sep 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A 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 examiners.

Device Story

Pre-powdered latex examination glove; utilizes oat starch powder as a donning agent. Device is disposable; worn on examiner's hand or finger. Primary function is barrier protection to prevent contamination between patient and healthcare provider during medical examinations. Used in clinical settings by medical personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex examination glove; pre-powdered with oat starch. Disposable, non-sterile, single-use. Form factor: hand-worn barrier.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners 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

SEP 2 7 1999

Mr. Said Awang Product Developmental and Technical QA Pamitex Industries Sdn. Bhd. Batu 2½, Jalan Rasah 70300 Seremban, Negeri Sembilan Darul Khusus Malaysia

K992117 Re : Pre-Powdered latex Exaination Glove with Trade Name: Oat-Starch Powder Regulatory Class: T Product Code: LYY Dated: June 12, 1999 Received: June 23, 1999

Dear Mr. Awang:

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 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 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

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Page 2 - Mr. Awang

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 asboing 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
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

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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510(k) NUMBER (IF KNOWN): K 992117

DEVICE NAME: Pre-powdered Latex Examination Gloves Powdered with Oat Starch Powder INDICATIONS FOR USE:

A 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 examiners. :

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Dental, Infection Control, and General Hospital Devices

| 510(k) Number | K992117 |
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| Prescription Use: (Per 21 CFR 801.109) | OR | Over The Counter Use: <span style="text-decoration: underline;">X</span> (Optional Format 1-2-95) |
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