VINYL EXAM GLOVES, POWDER FREE

K983494 · Glormed Intl., Inc. · LYZ · Nov 5, 1998 · General Hospital

Device Facts

• Record ID: K983494
• Device Name: VINYL EXAM GLOVES, POWDER FREE
• Applicant: Glormed Intl., Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This powder-free vinyl exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Device is a non-sterile, single-use, disposable vinyl examination glove. Worn by healthcare examiners on hands or fingers to provide a barrier against contamination between patient and examiner. Used in clinical or medical settings. No complex processing or electronic components; device functions as a physical barrier.

Clinical Evidence

Bench testing only. Device met or exceeded requirements for ASTM D5250, primary skin irritation, dermal sensitization, and FDA water leak testing (before and after aging).

Technological Characteristics

Vinyl material; non-sterile; single-use; disposable; manufactured in standard sizes. Complies with ASTM D5250 standards.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner in medical settings.

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

• Vinyl Exam Glove, Powdered (K981360)

Submission Summary (Full Text)

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NOV 5 1998

K983494

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## GLORMED INTERNATIONAL, INC VINYL EXAMINATION GLOVE, POWDER-FREE

| Submitter: | Janna Tucker & Associates<br>198 Avenue de la D'emerald<br>Sparks, NV 89434 | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--|
| | PHONE: | [phone] | |
| | FAX: | [phone] | |
| Contact Person: | Janna P. Tucker, President, Janna Tucker & Associates | | |
| Date Prepared: | September 30, 1998 | | |
| Trade Name: | (Multiple) Vinyl Examination Glove, Powder-Free | | |
| Common Name: | Vinyl Exam Glove, Powder-Free | | |
| Classification Name: | Patient Examination Glove, Class I, 80LYZ | | |
| Summary of Safety<br>and Effectiveness: | Information supporting claims of substantial equivalence, as<br>defined under the Federal Food, Drug and Cosmetic Act,<br>respecting safety and effectiveness is summarized below. For<br>the convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule ". . . (510(k) Summaries<br>and 510(k) Statements . . ." (21 CFR 807) and can be used to<br>provide a substantial equivalence summary to anyone requesting<br>it from the preparer. | | |
| | NEW DEVICE NAME: VINYL EXAMINATION GLOVE,<br>POWDER-FREE | | |
| | PREDICATE DEVICE NAME: Vinyl Exam Glove, Powdered,<br>K981360, everything is the<br>same process except for adding<br>powder to finished glove. | | |
| Device Description: | The device is powder-free vinyl exam gloves. They are non-<br>sterile, single use, disposable gloves. | | |
| Intended Use: | This powder-free vinyl exam glove is intended for medical<br>purposes that is worn on the examiner's hand or finger to prevent<br>contamination between patient and examiner. | | |

EXHIBIT I
Page 50 of 51

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| | Indications Statement: A patient examination glove is a disposable device intended for<br>medical purposes that is worn on the examiner's hand or finger to<br>prevent contamination between patient and examiner. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | This vinyl exam glove has the same technological<br>characteristics as predicate devices. The device is manufactured in<br>standard sizes. |
| Performance Data: | The device has met and/or exceeded the requirements of the<br>following standards and laboratory tests: |
| | ASTM D5250<br>Primary Skin Irritation Study<br>Dermal Sensitization Study<br>FDA Water Leak, before & after aging |
| | All tests were performed in a certified testing laboratory. |
| Conclusions: | Based on the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>device is substantially equivalent to other like devices under the<br>Federal Food, Drug, and Cosmetic Act. The predicate device<br>is the powdered vinyl glove of Glormed International, Inc.,<br>(К981360), except it is this new glove is powder-free. |

JANNA P. TUCKER, President Janna Tucker & Associates Official Correspondent for Glormed International, Inc.

EXHIBIT I

Page 51 of 51

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Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a caduceus or a staff with snakes, representing health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 NOV

Glormed International, Incorporated C/O Ms. Janna P. Tucker President Janna Tucker & Associates 198 Avenue de la D'Emerald Sparks, Nevada 89434

K983494 Re : Vinyl Exam Gloves, Powder-Free Trade Name: Regulatory Class: I Product Code: LYZ Dated: September 30, 1998 Received: October 5, 1998

Dear Ms. Tucker:

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 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). 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 (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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Tucker

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours, untin 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

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## APPLICANT: GLORMED INTERNATIONAL, INC.

K983494 510(K) NUMBER:

:

Vinyl Examination Glove, Powder-Free DEVICE NAME:

A 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K983494 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use X |
|------------------------------------------|----|------------------------|
|------------------------------------------|----|------------------------|

(Optional Format 1-2-96)

EXHIBIT B
Page 2 of 51

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