DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS

K992128 · Dash Medical Gloves Sdn Bhd · LYY · Sep 14, 1999 · General Hospital

Device Facts

• Record ID: K992128
• Device Name: DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
• Applicant: Dash Medical Gloves Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Sep 14, 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 purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable latex examination glove; siliconized polymer coated; powder-free. Designed for use by healthcare professionals in clinical settings to provide a protective barrier between examiner and patient. Prevents cross-contamination during medical examinations. Features protein content labeling claim of 50 micrograms or less.

Clinical Evidence

No clinical data provided; device is a standard patient examination glove.

Technological Characteristics

Latex material; siliconized polymer coating; powder-free; disposable; non-sterile; Class I medical device (Product Code LYY).

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

SEP 14 1999

Dash Medical Gloves Sdn. Bhd. c/0: Mr. Robert J. Sullivan Jr. President Dash Medical Gloves, Incorporated 10180 South 54th Street Franklin, Wisconsin 53132

K992128 Re : Dash Siliconized Polymer Coated Powder Free Trade Name: Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)/VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves Requlatory Class: । Product Code: LYY June 9, 1999 Dated: Received: June 23, 1999

Dear Mr. Sullivan:

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, Druq, 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. ਰੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 -Mr. Sullivan

obligation you might have under sections 531 through 542 of obligation you might have ahabi betronic Product Radiation che Act for devioes andorher Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marroos 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 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 gontact 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,

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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## 510(k) Number (if known): K992128

Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Device Name: Content Labeling Claim (50 micrograms or Less)

VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves Indications For Use:

> A patient examination glove is a disposable device intended for medical purposes 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)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K992178

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

(Optional Format 1-2-96)