QUALATEX POWDERED LATEX EXAMINATION GLOVES

K992557 · Tan Sin Lian Industries Sdn. Bhd. · LYY · Sep 14, 1999 · General Hospital

Device Facts

• Record ID: K992557
• Device Name: QUALATEX POWDERED LATEX EXAMINATION GLOVES
• Applicant: Tan Sin Lian Industries 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 patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.

Device Story

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

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex material; disposable; non-sterile; powdered form factor.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hands or fingers to prevent 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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 14 1999

Mr. Tan Tiow Gin Director Tan Sin Lian Industries Sdn. Bhd. No. 8, Taman Marin Jalan Haji Abdullah 84000 Muar, Johor, Malaysia

K992557 Re : Qualatex Powered Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: July 24, 1999 Received: July 30, 1999

Dear Mr. Gin:

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 aboye) 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. ರ್ಗ 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, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. 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 obligation you might have under sections 531 through 542 of

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Page 2 — Mr. Gin

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,

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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## INDICATION FOR USE STATEMENT 3.0)

| Applicant | : TAN SIN LIAN INDUSTRIES SDN BHD |
|------------------------|------------------------------------------------|
| 510K Number (if known) | : K992557 |
| Device Name | : Powdered patient latex<br>examination gloves |
| Indications for use | : |

A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.

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

(Division Sign-Off)
Division of Dental Infe control.

Division of Dental, Infer
Control,
and General Hospital D
510(k) Number. K992557

Prescription use Per 21 CFR 801.109 OR Over-The-Counter