POWDERFREE LATEX EXAMINATION GLOVE

K945247 · Sri Johani Sdn. Bhd. · LYY · Jan 2, 1995 · General Hospital

Device Facts

• Record ID: K945247
• Device Name: POWDERFREE LATEX EXAMINATION GLOVE
• Applicant: Sri Johani Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 2, 1995
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Device Story

Powder-free latex examination glove; intended for medical purposes to be worn on the examiner's hand to prevent contamination between patient and examiner. Device is a disposable, single-use barrier product used in clinical or hospital settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex material; powder-free; disposable; single-use; examination glove form factor.

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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[LOGO]

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

APR 2 2003

Mr. Lim Lee Aik

Managing Director

Sri Johani Sdn. Bhd.

Lot PT 7178, Balakong N/V,

43300 Seri Kembangan,

Selangor Darul Ehsan,

Malaysia

Re: K945247

Trade/Device Name: Powder-Free Latex Examination Gloves

Regulatory Class: I

Product Code: LYY

Dated: October 24, 1994

Received: October 27, 1994

Dear Mr. Aik:

This letter corrects our substantially equivalent letter of January 3, 1995 regarding the incorrect 510k number.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent 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 of the Act. The general controls provisions 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 Regulations, 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Aik

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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,

Susan Runner, DDS, MA

Interim Director

Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and
Radiological Health