SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

K013821 · Top Quality Mfg., Inc. · LYY · Mar 5, 2002 · General Hospital

Device Facts

• Record ID: K013821
• Device Name: SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
• Applicant: Top Quality Mfg., Inc.
• Product Code: LYY · General Hospital
• Decision Date: Mar 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Silk Touch Powdered Latex Examination Glove; disposable device; worn on examiner's hand or finger; prevents cross-contamination between patient and examiner; intended for medical purposes; features protein content labeling claim of 200 micrograms or less.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powdered latex examination glove; protein content labeling claim of 200 micrograms or less; disposable.

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

5 2002 MAR

Mr. Marc Sinkow Chief Operating Officer Top Quality Manufacturing, Incorporated 6800 Lindbergh Avenue Philadelphia, Pennsylvania 19142

Re: K013821

Trade/Device Name: Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim ( 200 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 28, 2002 Received: February 19, 2002

Dear Mr. Sinkow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/adma/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 Radiological Health

Enclosure

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510(k) Number (if known):

patient examination glove Powdered LatEx GAAM wiTH Device Name: Profess Content Labeling Claim (200 microcrams or LESS Indications For Use:

A patient examination glove is a disposable device intended for medical purposes worn A patient examiner's hand or finger to prevent contamination between patient and examiner.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Clive S. Lin

I Tivision Sign-Off) Dision of Dental, Infection Control, - nd General Hospital,Devic 111400 Number _

(Optional Format 1-2-96)