SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE

K992865 · Maxxim Medical · LYZ · Oct 13, 1999 · General Hospital

Device Facts

• Record ID: K992865
• Device Name: SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
• Applicant: Maxxim Medical
• Product Code: LYZ · General Hospital
• Decision Date: Oct 13, 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

SensiCare™ XP Vinyl Powder Free Medical Examination Glove; disposable vinyl glove; intended for medical examination to prevent cross-contamination between patient and examiner. Features lengthened cuff and increased thickness for procedural utility. Manufactured from poly(vinyl chloride) polymer with polyurethane coating on user side for donning/doffing without powder. Non-sterile; latex-free. Used in clinical settings by healthcare providers. Provides barrier protection; no automated processing or clinical decision support.

Clinical Evidence

Bench testing only. Compliance with ASTM D 5250-99 for freedom from holes, physical properties, and dimensions. Compliance with ASTM D 6124-97 for powder-free labeling. Biocompatibility testing per ISO 10993-Part 10 confirmed the device is non-irritating and non-sensitizing.

Technological Characteristics

Material: Poly(vinyl chloride) polymer with polyurethane coating. Form factor: Disposable, non-sterile, powder-free examination glove with lengthened cuff and increased thickness. Standards: ASTM D 5250-99 (physical properties/dimensions), ASTM D 6124-97 (powder-free), ISO 10993-10 (biocompatibility). No energy source or software.

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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OCT 1 3 1999

## ANNEX V

# SUMMARY OF SAFETY AND EFFECTIVENESS K992865

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

K992863

#### SUMMARY AND CERTIFICATION MAXXIM MEDICAL SENSICARE™ XP 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 SensiCare™ XP Vinyl Powder Free Examination Gloves. The Maxxim Medical SensiCare™ XP 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 SensiCare™ XP Vinyl Powder Free Examination Gloves are submitted in this 510(k) submission and are summarized as follows:

- 1. The gloves meet all ASTM D 5250-99 requirements for freedom from holes, physical properties 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.
- The glove is manufactured from a polymer and does not contain any natural rubber latex. ব

This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. The cuff of the glove has been lengthened and the thickness increased to promote use of the glove for procedures where such features are beneficial. It is made with a poly (vinyl 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.

Joye T. Moody
Signature of Certifier

**Joyce T. Moody**
(Typed Name)

Date

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 1999

Ms. Joyce T. Moody Vice President Regulatory Affairs/Quality Assurance Maxxim Medical Case Management Division 477 Commerce Blvd. Oldsmar, FL 34677

K992865 Re : SensiCare™ XP Vinyl Powder Free Examination Trade Name: Glove Regulatory Class: I Product Code: LYZ Dated: August 19, 1999 Received: August 25, 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. Existinq 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 - Ms. Moody

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 the Act 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 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 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 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,

Susan Cunnor

imothy 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. |
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K992845 510(k) Number:

for lick Maxxim Medical SensiCare™ XP Vinyl Powder Free Medical 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 Yes

Qhin S. Lin

(Division Sign-Off) Division of Dental, Infection C and General Hosp 510(k) Number