(MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES

K033229 · Bernard Technologies, Inc. · LYZ · Dec 17, 2003 · General Hospital

Device Facts

• Record ID: K033229
• Device Name: (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES
• Applicant: Bernard Technologies, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Device Story

Disposable powder-free vinyl examination glove; synthetic material construction. Used by healthcare personnel to provide a protective barrier against infectious materials and contaminants during patient examinations. Device functions as a physical barrier; no active components. Used in clinical settings. Benefits patient and clinician by reducing risk of cross-contamination.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing included primary skin irritation in rabbits and Buehler dermal sensitization test; both passed. Performance data confirmed compliance with ASTM D 5250-00 for dimensions, physical properties, and freedom from holes.

Technological Characteristics

Synthetic vinyl material. Meets ASTM D 5250-00 standards for dimensions, physical properties, and freedom from holes. Powder-free. Non-sterile.

Indications for Use

Indicated for use as a disposable barrier on the hand or fingers for medical purposes to protect against infectious materials and contaminants. Suitable for general patient examination.

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)

{0}------------------------------------------------

K033229

12/17/03

# BERNARD TECHNOLOGIES, INC.

- [1] 510(k) Summary
- [2] Bernard Technologies, Inc. 75 E. Wacker Dr. Chicago, IL 60601

Contact: Michael D. Lelah, PhD Telephone: [phone] Fax: [phone]

October 1, 2003

- (Multiple labels) Powder-Free Vinyl Examination Gloves [3] Trade Name: Common Name: Powder-Free Vinyl Examination Gloves Classification Name: Patient Examination Gloves, powder-free
- [4] Legally marketed device to which equivalency is being claimed: Class II powder-free patient examination glove 80LYZ, that meets all of the requirements of ASTM standard D 5250-00.
- Device Description: Class II powder-free patient examination glove 80LYZ, that meets િરો all of the requirements of ASTM standard D 5250-00.
- [୧] Intended Use: A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
- [7] Technological Characteristics:

| Characteristics | Standard |
|---------------------|---------------------|
| Dimensions | Meets ASTM D 5250-0 |
| Physical Properties | Meets ASTM D 5250-0 |
| Freedom from Holes | Meets ASTM D 5250-0 |
| Powder-Free | Meets ASTM D 5250-0 |

75 EAST WACKER DRIVE, SUITE 500 · CHICAGO, ILLINOIS · 60601 PHONE [phone] · FACSIMILE 312.337.0505

11

{1}------------------------------------------------

Biocompatibility:

Primary Skin Irritation in Rabbits Repeated Patch Dermal Sensitization Test (Buehler) Passes Passoc

Substantial Equivalence: Both in its intended use and/or physical characteristics, this device is equivalent to legally marketed vinyl powder-free gloves. Except for a plastisol ingredient, this device is substantially equivalent to legally marketed vinyl powder-free gloves.

- [8] Performance Data: Leaching and biocompatibility comparative studies between this device and legally marketed powder-free gloves demonstrate that this device is substantially equivalent to legally marketed vinyl powder-free gloves.
- (છે] Clinical data not required.
- [10] (Multiple labels) Powder-Free Vinyl Examination Gloves meet or exceed the ASTM standard. (Multiple labels) Powder-Free Vinyl Examination Gloves meet labeling claims and pinhole AQL from the Freedom from Holes data in [7] above.
- This summary will include any other standards, special controls, labeling, or regulatory [1] information reasonably deemed necessary by the FDA.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

DEC 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael D. Lelah, Ph.D. Managing Director, gloves Bernard Technologies, Incorporation 75 East Wacker Drive Chicago, Illinois 60601

Re: K033229

Trade/Device Name: (Multiple Labels) Powder- Free Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 1, 2003 Received: October 6, 2003

Dear Mr. Lelah;

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.

{3}------------------------------------------------

Page 2 -- Mr. Lelah

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Quls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

ಲ್ಲ

{4}------------------------------------------------

# K033229

## 3.0 Indications for Use Statement:

### INDICATIONS FOR USE

Applicant: Bernàrd Technologies, Inc.

510(k) Number: N.A.

Device Name: (Multiple labels) Powder-Free Vinyl Examination Gloves

Indications for Use: A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

> (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ._

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ✓ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

3