POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)

K984020 · Kossan Latex Industries(M)Sdn Bhd · LYY · Dec 23, 1998 · General Hospital

Device Facts

• Record ID: K984020
• Device Name: POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
• Applicant: Kossan Latex Industries(M)Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 examiner.

Device Story

Disposable powdered latex patient examination glove; intended for medical use to prevent cross-contamination between examiner and patient. Worn on hand or finger by healthcare professionals in clinical settings. Features protein content labeling claim of 150 micrograms or less per gram of glove. Device serves as physical barrier.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powdered latex material; disposable; physical barrier form factor. Protein content limited to 150 µg/g or less.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger 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 2 3 1998

Mr. Bob Chan General Manager Kossan Latex Industries (M) Sdn. Bhd. Lot 16632, 5¼ Miles, Jalan Meru, 41050 Klang Selangor Darul Ehsan, MALAYSIA

K984020 Re : Powdered Latex Examination Glove Trade Name: with Protein Content Labeling Claim (150 micrograms or less) Regulatory Class: I Product Code: LYY November 7, 1998 Dated: November 12, 1998 Received:

Dear Mr. Chan:

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 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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Chan:

through 542 of the Act for devices under the Electronic Chrough 542 or the not on provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Info recei will aremarket notification. The FDA described in your Sioth, prematics of your device to a legally marketed predicate device results in a classification for your marketed predicate device rubated in the to proceed to the market.

If you desire specific advice for your device on our labeling If you debite bpcorres and additionally 809.10 for in regulation (2) er erdevices), please contact the Office of Victo diagnobero at [phone]. Additionally, for questions on Compriance at (50x) dvertising of your device, please contact the Office of Compliance at [phone]. Also, please note the office or comparied, "Misbranding by reference to ene regalablie in (21CFR 807.97). Other general premation on your responsibilities under the Act may be firstmation on your copyon of Small Manufacturers Assistance obtained from the biving [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamafin.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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Section 3

Page 1 of 1

510 (K) Number (if known): K 984020

Device Name : Latex Patient Examination Glove with protein content
Powdered
labeling claim (150 µg/g glove or less)

Indications For Use

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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 examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ( Per 21 CFR 801. 109 ) OR

Over-The-Counter Use

( Optional Format 1-2-96 )

Hamilsty Cilim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number _