HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE

K992730 · Hwa Teh Industrial Sdn. Bhd. · LYY · Sep 14, 1999 · General Hospital

Device Facts

• Record ID: K992730
• Device Name: HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
• Applicant: Hwa Teh Industrial Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

HWA and Silktex Powdered Latex Examination Gloves are protective barriers worn on the hands of healthcare personnel. The gloves function as a physical barrier to prevent contamination between the healthcare worker and the patient's body, fluids, waste, or environment. They are intended for use in clinical or healthcare settings to reduce the risk of cross-contamination. The device is a single-use, disposable glove.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powdered latex examination gloves. Material: Latex. Form factor: Hand-worn protective barrier. Sterilization: Not specified.

Indications for Use

Indicated for use by healthcare workers and similar personnel to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment.

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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1999

Mr. K. Karunakaran Ouality Assurance Manager Hwa Teh Industrial Sdn. Bhd. Lot 187, Sungai Darah 45600 Batang Berjuntai Selangor Darul Ehsan, Malaysia

Re: K992730 Trade Name: HWA and Silktex Pre-Powered Latex Examination Gloves Requlatory Class: I Product Code: LYY Dated: Auqust 11, 1999 Received: August 13, 1999

Dear Mr. Karunakaran:

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. 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Karunakaran

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 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.fdag.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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510 (k) Number (if known) : K9912730

Device Name : HWA and Silktex Powdered Latex Examination Gloves

Indication For Use :

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

La. Culatrak

(Division Sign Off) Division of Demal, Infection Control, and General Hospital 510(k) Number _

Prescription Use (Per 21 CFR 801.109) OR Over The Counter Use

(Optional Format 1-2-95)