POWDERFREE GREEN NITRILE EXAMINATION GLOVES

K981673 · Besglove Medicare Sdn. Bhd. · LZA · Jul 28, 1998 · General Hospital

Device Facts

• Record ID: K981673
• Device Name: POWDERFREE GREEN NITRILE EXAMINATION GLOVES
• Applicant: Besglove Medicare Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 28, 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable powder-free green nitrile examination glove; worn on examiner's hand/finger; acts as physical barrier to prevent cross-contamination between patient and examiner; used in clinical settings; intended for over-the-counter use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Nitrile rubber; Form factor: Disposable examination glove; Powder-free; Color: Green.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners 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

JUL 28 1998

Mr. Lee Aik Lim Managing Director Besglove Medicare Sdn. Bhd. Lot 6, Jalan P/2A, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor Darul Ehsan, MALAYSIA

Re: K981673 Powder-Free Green Nitrile Examination Gloves Trade Name: Requlatory Class: I Product Code: LZA Dated: May 7, 1998 Received: May 12, 1998

Dear Mr. Lee Aik Lim:

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 requlations 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) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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## Page 2 - Mr. Lee Aik Lim

the Act for devices under the Electronic Product Radiation the Act for devices under one moder chams or regulations.

This letter will allow you to begin marketing your device as Info recei will as on the motification. The FDA described in your sie\n puivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate actros 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 che 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 CRR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obcained from the bryin [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Dutrem per

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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长981673 510(k) number(if known): _

Device Name: Powderfree Green Nitrile Examination Gloves

Indications For Use:

A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Olin S. Lin

(Division Sign Off) Division of Dental. Infection and General Hosp. 510(k) Number

Prescription Use (Per 21 CFR 801.109)

1. 1. 1. 1. 1. 1.

Over-The-Counter Use X

(Optional Format 1-2-96)