ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

K013537 · Koon Seng Sdn Bhd · LYY · Dec 7, 2001 · General Hospital

Device Facts

• Record ID: K013537
• Device Name: ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
• Applicant: Koon Seng Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Pre-Powdered Patient Examination Gloves is a disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Disposable powdered latex examination glove; intended for use by healthcare professionals to prevent cross-contamination between patient and examiner; features protein content labeling claim of 200 micrograms or less; worn on hands or fingers during medical examinations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powdered latex material; disposable; patient examination glove; Class I device; product code LYY.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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 0 7 2001

Mr. Lim Weng Heng Factory Manager Koon Seng Sdn Bhd PTD 3274 Batu 4 1/2 Jalan Bakri Muar Johor, MALAYSIA

## Re: K013537

Trade/Device Name: Royal Imperial Powdered Latex Examination Gloves with Protein Control Labeling Claim ( 200 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 23, 2001 Received: October 23, 2001

## Dear Mr. Heng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 Antichunches, or to de rises and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr. ), it may 80 casyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled of a bases and institution the became is a mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally Federal statutes and regulations, but not limited to: registration You must colliply with an the Fec 3 requires (21 CFR Part 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 800); and i and listing (21 CFR I art 607), lacems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will and w you to begin manteening your of substantial equivalence of your device to 510(K) premarket nothleadon: "The Fesults 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 II you desire specific ad rise 10. Join in vitro diagnostic devices), please contact the and additionally 21 CFR rar. 6091-4618. Additionally, for questions on the promotion and Office of Comphiance at (301) 39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . advertising of your avrited, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notification (210) it it all 00197).
the Act may be obtained from the Division of Small Manufacturers, 1984 - 1997 the Act may be obtained nom and Benumber [phone] or [phone] or at its Consumer / issistance at ho vov - fda gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Rl. Allatord

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement : Include the following or equivalent for Use page. The 3.0 information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.

## INDICATIONS FOR USE.

| Applicant : | Koon Seng Sdn. Bhd. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number (if known): | K 013537 |
| Device Name: | ROYAL IMPERIAL LATEX Pre-Powdered Patient Examination Gloves WITH PROTEIN CONTENT |
| Indications For Use: | LABELING CLAIM (200 MICROGRAMS OR LESS) Pre-Powdered Patient Examination Gloves is a disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner. |

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Concurrence of CDRH Office of Device Evaluation ( ODE)

Qiu S. Lin

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

Prescription Use Per 21 CFR S 01.109 ાર

Over - The - counter _____________

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