POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE

K991615 · Maxxim Medical · LZA · Jul 30, 1999 · General Hospital

Device Facts

• Record ID: K991615
• Device Name: POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE
• Applicant: Maxxim Medical
• Product Code: LZA · General Hospital
• Decision Date: Jul 30, 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

Non-sterile, powder-free, polyurethane examination glove; intended for medical and dental use. Device acts as a protective barrier worn on the examiner's hand to prevent cross-contamination between patient and examiner. Manufactured from polyurethane polymer with a polyurethane coating on the user side to facilitate donning and doffing without powder or chemical release agents. Device is latex-free. Used in clinical and dental settings by healthcare professionals.

Clinical Evidence

Bench testing only. No clinical data. Testing included physical properties and dimensions per ASTM D 3578-95, powder-free status per ASTM D 6124-97, and biocompatibility (irritation and sensitization) per ISO 10993-10.

Technological Characteristics

Material: Polyurethane polymer with polyurethane coating. Form factor: Disposable, non-sterile, powder-free examination glove. Standards: ASTM D 3578-95 (physical properties/dimensions), ASTM D 6124-97 (powder-free). Biocompatibility: ISO 10993-10. Latex-free.

Indications for Use

Indicated for use as a disposable medical/dental examination glove 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

• Nitra-Touch Nitrile Powder Free Medical Examination gloves (K965095)
• SensiCare Powder Free Vinyl Medical Examination gloves (K944182)

Submission Summary (Full Text)

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JUL 29 1999

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

Amended 7-13-99 K991615

## SUMMARY AND CERTIFICATION MAXXIM MEDICAL POLYURETHANE POWDER FREE MEDICAL/DENTAL EXAMINATION GLOVES

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

Common Name: Medical Examination Gloves Dental 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 Polyurethane Powder Free Examination Gloves. The Maxxim Medical Powder Free Polyurethane Medical/Dental Examination glove is substantially equivalent to the Nitra-Touch™ Nitrile Powder Free Medical Examination gloves and SensiCare™ Powder Free Vinyl Medical Examination gloves, originally cleared under K965095 and K944182 respectively. The results of the safety, efficacy and performance testing of the Polyurethane Powder Free Examination Gloves are submitted in this 510(k) submission and are summarized as follows:

- The gloves meet all ASTM D 3578-95 requirements for freedom from holes, physical properties 1. and physical dimensions, except ultimate elongation before aging.
- The gloves have been tested and have been shown to be non-irritating and non-sensitizing when 2. tested in accordance with ISO10993-Part 10.
- The gloves meet requirements of ASTM D 6124-97 for labeling as powder free. No powders are ന് utilized in the manufacture of this glove.
- 4. The glove is manufactured from a polymer and does not contain any natural rubber latex.

This product is a powder free, non-sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane 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 both as medical examination gloves and dental examination gloves. All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices.

Oyse T. Mordy

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Signature of Certifier

Jovce T. Moodv (Typed Name)

7-13-99

Date

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

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

Re: K991615 Polyurethane Powder Free Medical/Dental Trade Name: Examination Glove Requlatory Class: I Product Code: LZA Dated: May 7, 1999 Received: May 10, 1999

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 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. 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Ms. Moody

this response to your premarket notification Please note: 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 requlations.

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 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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## INDICATIONS FOR USE STATEMENT

Applicant:

Maxxim Medical, Inc.

1615

510(k) Number:

Maxxim Medical Polyurethane Powder Free Medical/Dental Examination Gloves Device Name:

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

Qiu S. Lin

(Division Sion-OH) Division of Dental, Infection Cor and General Hospit 510(k) Number