VINYL EXAMINATION GLOVES, POWDER FREE

K982933 · General Gloves Corp. · LYZ · Nov 6, 1998 · General Hospital

Device Facts

• Record ID: K982933
• Device Name: VINYL EXAMINATION GLOVES, POWDER FREE
• Applicant: General Gloves Corp.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 6, 1998
• 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

Vinyl examination glove; powder-free; disposable. Worn by healthcare examiners on hands or fingers; acts as barrier to prevent cross-contamination between patient and examiner. Device meets ASTM D 5250-92 standards for physical dimensions and tensile strength. Used in clinical settings.

Clinical Evidence

No clinical data. Bench testing only, including physical requirements (tensile strength, elongation) per ASTM D573 and D5250-92, and pinhole leak testing.

Technological Characteristics

Vinyl polymer; powder-free. Dimensions and tolerances per ASTM D 5250-92. Physical requirements tested per ASTM D573 (accelerated aging). Biocompatibility testing performed on polymer-coated vinyl.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent 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 (meets ASTM D 5250-92)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for General Gloves Corp. The logo includes the company name in bold, black letters, with the first letter "G" stylized and enlarged. Above the company name, the text "NOV 6 1998" is visible, likely indicating a date. Below the company name, there is text in a different language, possibly Chinese, which translates to "General Gloves International Co., Ltd."

ei Ma 16 Lin Tung Chung Village Tung Shan Hsiang. Tainan Hsien. Taiwan 73

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

982933

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:

Tel: [phone] Fax: [phone]

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

Date summary prepared: September 23, 1998

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Image /page/1/Picture/0 description: The image shows a logo with two overlapping letters, 'G' and 'G', with the letters in different styles. The first 'G' is outlined in black, while the second 'G' is filled in with black. To the right of the letters, there is a small 'TM' symbol, indicating a trademark.

## GENERAL GLOVES CORP.

通用手套國際股份有限公司

K982937

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

| 2). Trade name: "G G" vinyl examination gloves powder-free | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------|------------|------------|------------|--------------|--------------------------|
| Common name: Exam gloves | | | | | | | |
| Classification name: Patient examination glove (per 21 CFR 880.6250) | | | | | | | |
| 3). Legally marketed device: Class I vinyl patient examination glove 80LYZ, powder-free, that meets all the requirements of ASTM D 5250 - 92. | | | | | | | |
| 4). Description of the device: Class 1 vinyl patient examination glove 80LYZ, powder-free, 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) |
| | length | 230<br>230 | 230<br>230 | 230<br>230 | 230<br>230 | min.<br>min. | ASTM D 5250<br>(General) |

Biocompatability data are conducted on the polymer coated vinyl gloves.

.

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Image /page/2/Picture/0 description: The image shows the logo for General Gloves Corp. The logo features a stylized "G" and the company name in bold, black letters. Below the company name is the Chinese translation of the company name, "通用手套國際股份有限公司". There is also a handwritten number "K982933".

## No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, 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)

Tensil strength (Mpa, min) Ultimate Elongation (%, 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 qloves meet the labeling claims as shown by the data in (a) (6) .

.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flow.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

General Gloves Corporation C/O David Hu, Ph.D., President Sponsors's Representative HTI Trading Group 3423 Investment Boulevard, Suite 12 Hayward, California 94545-3822

Re: K982933 Vinyl Examination Gloves, Powder-Free Trade Name: Regulatory Class: I Product Code: LYZ October 26, 1998 Dated: Received: October 29, 1998

Dear Dr. 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 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. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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 - Dr. Hu

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 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" (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,

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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Page Page of

K982933 510(k) Number (if known): Patient examination glove 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 or finger to prevent contamination between patient and examiner.

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

Prescription Jise Over-The-Counter Use (Per 21 CFR 801.109) (Division Sign-Off) (Optional Format 1-2-96) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)