POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)

K993500 · Besglove Medicare Sdn. Bhd. · LYY · Dec 2, 1999 · General Hospital

Device Facts

• Record ID: K993500
• Device Name: POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
• Applicant: Besglove Medicare Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Dec 2, 1999
• 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 pervent contamination between patient and examiner.

Device Story

Disposable powder-free latex examination glove; polymer coated; features protein label claim of 50 micrograms or less. Used by healthcare professionals in clinical settings to provide a protective barrier between examiner and patient; prevents cross-contamination. Device is worn on hands/fingers during examinations.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Latex material; polymer coated; powder-free; disposable; non-sterile examination glove.

Indications for Use

Indicated for use as a disposable medical glove 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

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

Re : K993500 Trade Name: Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim of 50 micrograms or less) Regulatory Class: I Product Code: LYY October 11, 1999 Dated: Received: October 15, 1999

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). T 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 Regulations, 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 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

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Page 2 - Mr. Lim

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 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,

Patino Cuerdi //oc

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

Enclosure

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Attachment 9

K 99 35 ∅∅

510 (K) number (if known) : _

Device Name : Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50 MICROGRAMS OR LESS

Indications For Use :

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Clim S. Lim

(Division Sign Off) Division of Dental, Infection Control, and General Hospital Dev 510(K) Number

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use ાર