BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES

K992107 · General Gloves Corp. · LYZ · Aug 23, 1999 · General Hospital

Device Facts

• Record ID: K992107
• Device Name: BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
• Applicant: General Gloves Corp.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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

Disposable vinyl examination gloves; worn by healthcare providers on hands or fingers; intended to provide a barrier to prevent contamination between patient and examiner. Device is non-sterile; used in clinical settings. Performance verified against ASTM D 5250-92 standards for dimensions, tensile strength, and ultimate elongation. Biocompatibility testing conducted. Pinhole testing performed to ensure barrier integrity.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing (tensile strength, elongation) per ASTM D573 and D5250-92, and biocompatibility assessment.

Technological Characteristics

Vinyl material; powder-free; disposable. Dimensions and physical requirements (tensile strength 9.0 MPa min, ultimate elongation 300% min) meet ASTM D 5250-92 standards. Inspection level S-2, AQL 4.0.

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

• Class I vinyl patient examination glove 80LYZ

Submission Summary (Full Text)

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K992107

## TM ERAL GLOVES CORP.

通用手套國際股份有限公司

No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733, R. O. C.

510 (k) SUMMARY) [As required by §807.92(c)]

Submitter's name and address: HTI Trading Group 1) . 3423 Investment Blvd. Suite 12 Hayward, CA 94545

Telephone and Fax numbers of submitter:

510-732-9623 Tel: Fax: [phone]

AUG 2 3 1999

David Hu, Ph.D., President Contact person:

Date summary prepared: June 21, 1999

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K992107

## GENERAL GLOVES CORP.

### 通用手套國際股份有限公司

T M

No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.

| 2). | Trade name: "G G" vinyl examination gloves powder-free | | | | | | |
|------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|------------|------------|-----------|--------------------------|
| | Common name: Exam gloves | | | | | | |
| | Classification name: Patient examination glove<br>(per 21 CFR 880.6250) | | | | | | |
| 3). | Legally marketed device: Class I vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92. | | | | | | |
| 4). | Description of the device: Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92. | | | | | | |
| 5). | Intended use of device: 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. | | | | | | |
| 6a). | Technological characteristics compared to ASTM standard D 5250 - 92: | | | | | | |
| | Dimension and tolerance (S-2, AQL 4.0) | | | | | | |
| | | S | M | L | XL | Tolerance | |
| | width | 85<br>87 | 95<br>97 | 105<br>107 | 115<br>117 | +5<br>+3 | ASTM D 5250<br>(General) |

230 230 length 230 230 min. ASTM D 5250 230 230 230 230 min. (General)

Biocompatability data are conducted on the powdered vinyl gloves .

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K992107

# ERAL GLOVES CORP.

通用手套國際股份有限公司

No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.

- Physical requirements 6a) .
Before and after accelerated aging 70 + 2 C for 72 + 2 hours, according to D573. (Inspection level S-2, AQL 4.0)

Ultimate Elongation (%, min) Tensil strength (Mpa, min) 300 9.0

- Assessment of performance data (non-clinical tests): 6b(1) . .
The performance test data is the same as for 807.92(a)96) mentioned immediately above.

- Assessment of performance data (clinical tests) : 6b(2) . Not required.
- Our gloves meet or exceed the ASTM or equivalent standard. 6b(3) . Our gloves meet FDA pinhole requirements.

Our gloves meet the labeling claims as shown by the data in (a) (6) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 1999

General Gloves Corporation C/O Mr. David Hu, Ph.D. President HTI trading Group 3423 Investment Boulevard # 12 Hayward, California 94545

Re : K992107 Baldur Brand Vinyl Powdered Examination Gloves Trade Name: Requlatory Class: I Product Code: LYZ Dated: June 21, 1999 Received: July 01, 1999

Dear Mr. Hu:

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 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 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 successful in regulatory action. In addition, FDA may publish further 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.

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Page 2 - Mr. Hu

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 Ehus, 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 Additionally, for questions on the promotion and [phone]. 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 Other general information on your responsibilities CFR 807.97). 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy Ulatowsk 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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## GENERAL GLOVES CORP.

通用手套國際股份有限公司

No. 25, Pei Ma, 16 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.
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#### STATEMENT OF INDICATIONS FOR USE [807.92(a) (5) ] .

patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger 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) OR

Over-The-Counter-Use (Optional Format 1-2-96

Olin S. Lin

on Sign-Off) sion of Dental, Inte i General Ho 510(k) Numb

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