POWDERFREE LATEX EXAMINATION GLOVES

K980194 · Besglove Medicare Sdn. Bhd. · LYY · Mar 13, 1998 · General Hospital

Device Facts

• Record ID: K980194
• Device Name: POWDERFREE LATEX EXAMINATION GLOVES
• Applicant: Besglove Medicare Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 13, 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 latex examination glove; worn by healthcare personnel on hands or fingers; acts as physical barrier to prevent cross-contamination between patient and examiner during medical procedures; intended for single use; non-sterile; powder-free.

Clinical Evidence

No clinical data provided; device relies on bench testing and compliance with established standards for examination gloves.

Technological Characteristics

Material: Latex; Type: Powder-free; Form factor: Disposable examination glove; Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners on 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

MAR 1 3 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

K980194 Re : Powderfree Latex Examination Gloves Trade Name: Regulatory Class: I Product Code: LYY Dated: January 12, 1998 January 20, 1998 Received:

Dear Mr. 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 regulations affecting your device can be found in the Code of --Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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.

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Paqe 2 - Mr. Lim

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ents affect any obligation you might have under sections 531 through 542 of 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 fo
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,

J. Watrust

Timot My 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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Attachment 8

510(k) number(if known): K 980194

Device Name: Powderfree Latex Examination Gloves

Indications For Use:

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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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Chiu Si him

(Division Sign Off) Division of Dental, Infection Control, and General Hospita 510(k) Number

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

(Optional Format 1-2-96)