TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE

K992122 · Maxxim Medical · LYZ · Jul 15, 1999 · General Hospital

Device Facts

• Record ID: K992122
• Device Name: TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
• Applicant: Maxxim Medical
• Product Code: LYZ · General Hospital
• Decision Date: Jul 15, 1999
• 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 that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Tru-Touch™ PF Vinyl Powder Free Medical Examination Gloves are non-sterile, disposable gloves made from poly(vinyl chloride) polymer with a polyurethane coating on the user side. The polyurethane coating facilitates donning and doffing without the need for donning powder. The device is intended for use by healthcare professionals during medical examinations to prevent contamination between the patient and the examiner. The gloves are available in various sizes and are manufactured without natural rubber latex or release powders.

Clinical Evidence

Bench testing only. The device met ASTM D 5250-92 requirements for physical properties, dimensions, and freedom from holes. It met ASTM D 6124-97 requirements for powder-free status. Biocompatibility testing (ISO 10993-Part 10) demonstrated the device is non-irritating and non-sensitizing.

Technological Characteristics

Material: Poly(vinyl chloride) polymer with polyurethane coating. Non-sterile. Powder-free. Complies with ASTM D 5250-92 (physical properties/dimensions) and ASTM D 6124-97 (powder-free). Latex-free.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand 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.

Predicate Devices

• SensiCare™ Powder Free Vinyl Medical Examination gloves (K944182)

Submission Summary (Full Text)

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Maxxim Medical, Inc. 477 Commerce Blvd. Oldsmar. FL 34677 Phone: [phone] Fax: [phone]

K992122

## SUMMARY AND CERTIFICATION MAXXIM MEDICAL TRU-TOUCH™ PF VINYL POWDER FREE MEDICAL EXAMINATION GLOVES

Class I (classification by the General Hospital and Personal Use Device Panel)

Common Name: Medical Examination Gloves

Classification Name: Patient Examination Glove (21 CFR 880.6250)

The purpose of this 510(k) is to obtain an FDA clearance for manufacturing and distributing Tru-Touch™ PF Vinyl Powder Free Examination Gloves. The Maxxim Medical Tru-Touch™ PF Vinyl Powder Free Medical Examination glove is substantially equivalent to the SensiCare™ Powder Free Vinyl Medical Examination gloves, originally cleared under K944182. The results of the safety, efficacy and performance testing of the Tru-Touch™ PF Vinyl Powder Free Examination Gloves are submitted in this 510(k) submission and are summarized as follows:

- The gloves meet all ASTM D 5250-92 requirements for freedom from holes, physical properties 1. and physical dimensions.
- 2. The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO10993-Part 10.
- 3. The gloves meet requirements of ASTM D 6124-97 for labeling as powder free. No powders are utilized in the manufacture of this glove.
- ব The glove is manufactured from a polymer and does not contain any natural rubber latex.

This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. It is made with a poly (viny) Chloride) polymer and a polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed as medical examination gloves. All requirements for physical properties and dimensions have been met for this intended use.

Joyce T. Moody

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Signature of Certifier

Joyce T. Moody
(Typed Name)

June 21, 1999
Date

28

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble waves or fabric.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Ms. Joyce T. Moody Vice President Regulatory Affairs/Quality Assurance Maxxim Medical, Incorporated 477 Commerce Boulevard Oldsmar, Florida 34677

Re : K992122 Tru-Touch™ PF Vinyl Powder Free Examination Trade Name: Glove Requlatory Class: I Product Code: LYZ Dated: June 21, 1999 June 23, 1999 Received:

Dear Ms. Moody:

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 aqainst 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Moody

Please note: this response to your premarket notification Please note: this reportion ou folligation you might have under submission docb not arross and one for devices under the sections 551 chrough 315 control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis recei will arrow foaremarket notification. The FDA described in your 510 m, promalence of your device to a legally Finding of Subscancial equiralist in a classification for your marketed predicate as to 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 compriance as (advertising of your device, please contact the Dffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Information on your copien of Small Manufacturers Assistance obtained from the Divibion [phone] or [phone] or at its internet address "http://www.fday.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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## INDICATIONS FOR USE STATEMENT

| Applicant: | Maxxim Medical, Inc. |
|----------------|---------------------------------------------------------------------------|
| 510(k) Number: | K992122 |
| Device Name: | Maxxim Medical Tru-Touch PF Vinyl Powder Free Medical Examination Gloves |

Indications for Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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

Over the Counter Yes *_*_

Chun S. Lin

(Division Sign-Off) Division of Dental, Infec and General Hospita 510(k) Number