PERCUGUARD

K992539 · Digit-Pro · LZB · Feb 18, 2000 · General Hospital

Device Facts

• Record ID: K992539
• Device Name: PERCUGUARD
• Applicant: Digit-Pro
• Product Code: LZB · General Hospital
• Decision Date: Feb 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The intended use of PERCUGUARD ™ is to prevent accidental needle stick and/or sharps injuries to healthcare workers on the fingers and thumbs exposed lo injuries. It is a protective finger guard accessory to the examination glove. It is used on the finger and/or the thumb of the non-dominant hand usually used to retract, stabilize. or isolate in preparation for an injection procedure. Il may be inverted and used to prevent accidental needle sticks while suluring. It can be used on the dominant hand (device inverted) when isolating, retracting, stabilizing, or palpating tissue where sharp bone or wires are present in order to protect the palm side of the fingers or thumbs

Device Story

Percuguard is a protective finger guard accessory worn over examination gloves; designed to prevent accidental needle stick and sharps injuries to healthcare workers. Device is worn on fingers or thumbs of non-dominant hand during retraction, stabilization, or isolation for injections; can be inverted for use during suturing or on dominant hand when palpating tissue near sharp bone or wires. Provides physical barrier against sharps; intended for use in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Protective finger guard accessory; worn over examination gloves; physical barrier design. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for healthcare workers to prevent accidental needle stick and/or sharps injuries to fingers and thumbs during injection, suturing, or tissue palpation procedures involving sharp bone or wires.

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

FEB 1 8 2000

M. Kevin Sorrels, D.D.S. Digit-PRO, Inc. 105555 West Little York Road Houston, Texas 77041-4011

Re: K992539 Percuguard™ Trade Name: Requlatory Class: I Product Code: LZB December 20, 1999 Dated: Received: December 21, 1999

Dear Dr. Sorrels:

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 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 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

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Page 2 - Dr. Sorrels

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 obligation 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 debting 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 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,

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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Device Name:

Per acquirand

Statement of Indication of Use

The intended use of PERCUGUARD ™ is to prevent accidental needle stick and/or sharps injuries to healthcare workers on the fingers and thumbs exposed lo injuries.

It is a protective finger guard accessory to the examination glove. It is used on the finger and/or the thumb of the non-dominant hand usually used to retract, stabilize. or isolate in preparation for an injection procedure. Il may be inverted and used to prevent accidental needle sticks while suluring. It can be used on the dominant hand (device inverted) when isolating, retracting, stabilizing, or palpating tissue where sharp bone or wires are present in order to protect the palm side of the fingers or thumbs

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

SPb for Clin

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