SYNTHETIC EXAMINATION GLOVE, POWDERED

K981876 · Hsing YI Plastics Processing Co, Ltd. · LYZ · Sep 30, 1998 · General Hospital

Device Facts

• Record ID: K981876
• Device Name: SYNTHETIC EXAMINATION GLOVE, POWDERED
• Applicant: Hsing YI Plastics Processing Co, Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 30, 1998
• 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 or finger to prevent contamination between patient and examiner.

Device Story

Powdered synthetic vinyl examination glove; nonsterile; single-use; disposable. Worn by healthcare examiners on hands or fingers during medical procedures. Acts as a physical barrier to prevent contamination between patient and examiner. Standardized sizing.

Clinical Evidence

Bench testing only. Testing included ASTM D5250 standard compliance, primary skin irritation study, dermal sensitization study, FDA surgical glove bio-burden test, and FDA water leak testing (before and after aging).

Technological Characteristics

Synthetic vinyl material; powdered; nonsterile; single-use; disposable. Manufactured in standard sizes. Complies with ASTM D5250 standards. No electronic or software components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

• Synthetic Vinyl Exam Glove (K981876)

Submission Summary (Full Text)

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SEP 3 0 1998

## JANNA TUCKER & ASSOCIATES

198 Avenue de la D'Emerald Sparks, NV 89434 Ph: 702-342-2612 Fax: [phone]

981876

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## HSING YI PLASTICS PROCESSING CO., LTD SYNTHETIC VINYL EXAMINATION GLOVE, POWDERED

Janna P. Tucker, President, Janna Tucker & Associates

Submitter:

Janna Tucker & Associates 198 Avenue de la D'emerald Sparks, NV 89434

[phone] PHONE: FAX: [phone]

Contact Person:

Date Prepared:

May 26, 1998 (Revised July 6, 1998)

(Multiple) Synthetic Vinyl Examination Glove Trade Name: Synthetic Vinyl Exam Glove Common Name: Classification Name: Patient Examination Glove, Class I, 80LYZ

Summary of Safety and Effectiveness:

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "... (510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the preparer.

NEW DEVICE NAME:

SYNTHETIC VINYL EXAMINATION GLOVE, POWDERED

PREDICATE DEVICE NAME: Synthetic Vinyl Exam Glove

Device Description:

The device is powdered synthetic vinyl exam glove. They are nonsterile, single use, disposable gloves.

This synthetic vinyl exam glove is intended for medical purposes Intended Use: that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

EXHIBIT I
Page 23 of 24 (Revised 7/6/98)

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| Indications Statement: | 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. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | This synthetic vinyl exam glove has the same technological characteristics as predicate devices. The device is manufactured in standard sizes. |
| Performance Data: | The device has met and/or exceeded the requirements of the following standards and laboratory tests: |
| | ASTM D5250 |
| | Primary Skin Irritation Study |
| | Dermal Sensitization Study |
| | FDA Surgical Glove Bio-Burden Test |
| | 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 807) and the information provided herein, we conclude that the device is substantially equivalent to other like devices under the Federal Food, Drug, and Cosmetic Act. |

·

JANNA P. TUCKER, President Janna Tucker & Associates Official Correspondent for Hsing Yi Plastics Processing Co., Ltd

EXHIBIT I

Page 24 of 24 (Revised 7/6/98)

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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 features a stylized image of three human profiles facing right, layered on top of each other. The profiles are black and have a minimalist design. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Hsing Yi Plastic Processing Company, Limited C/O Ms. Janna P. Tucker President Janna Tucker & Associates 198 Avenue de la D'Emerald Sparks, Neveda 89434

Re : K981876 Trade Name: Synthetic Vinyl Examination Glove, Powdered Requlatory Class: I Product Code: LYZ Dated: September 22, 1998 Received: September 18, 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 leqally 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. ਰੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (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 requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 qeneral 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, ………………

Susan Biare

fe

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

..

APPLICANT:

HSING YI PLASTICS PROCESSING CO., LTD.

510(K) NUMBER:

K981876

DEVICE NAME:

Synthetic Vinyl Examination Glove, Powdered

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 | 1951876 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

ATCH5
EXHIBIT B
Page 2 of 24 (Revised 7/6/98)