SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K992821 · Shijiazhuang Hongxiang Plastics Products Co., Ltd. · LYZ · Mar 10, 2000 · General Hospital

Device Facts

• Record ID: K992821
• Device Name: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shijiazhuang Hongxiang Plastics Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 10, 2000
• 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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Synthetic powder-free vinyl patient examination gloves; disposable protective barrier; worn on examiner's hand or finger; prevents contamination between patient and examiner; used in clinical or medical settings; no complex electronics or software; manual operation.

Clinical Evidence

Bench testing only. Testing included physical dimensions and physical properties per ASTM D5250-92, FDA 1000 ml water fill test for pinholes, and biocompatibility testing (primary skin irritation and skin sensitization).

Technological Characteristics

Vinyl material; powder-free; disposable; meets ASTM D5250-92 standards; physical dimensions and pinhole testing conducted per FDA requirements.

Indications for Use

Indicated for use by healthcare personnel as a disposable protective barrier worn on the hand or finger to prevent cross-contamination between the examiner and the patient.

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

• Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves (K964964)
• Cheer & Merit Co., Ltd. Powder-Free Vinyl Patient Examination Gloves (K942042)

Submission Summary (Full Text)

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# 510(K) SUMMARY K 992821

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

#### 1. Submitter's Identification:

Mr. Guixi Liu Shijiazhuang Hongxiang Plastics Products Co., Ltd. Lu Quan City, New High technologies Industrial Zone Shijiazhuang, Hebei Province 050200 P.R. China

Date Summary Prepared: July 29, 1999

#### 2. Name of the Device:

Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves

#### 3. Predicate Device Information:

Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#964964 Cheer & Merit Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#942042

#### Device Description: 4.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.

#### 5. Intended Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

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#### 6. Comparison to Predicate Devices:

Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves and the Cheer & Merit Powder-Free Vinyl Patient Examination Gloves.

### 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for Shijiazhuang Hongxiang Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AOL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims. We adhere to all USP Iodine test methodogy and testing conducted revealed passing results.

#### 8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

#### 9. Conclusions:

Shijiazhuang Hongxiang Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powder-Free) conform fully to ASTM-D-5250-92 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements. biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The text is in all capital letters and is evenly spaced around the circle.

MAR 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Hongxiang Plastics Products Co., Ltd. C/O Basic Medical Industries, Inc. James Chu 12390 East End Avenue Chino, California 91710

Re : K992821 Synthetic Powder-Free Vinyl Patient Trade Name: Examination Gloves Requlatory Class: I Product Code: LYZ Dated: February 28, 2000 Received: March 2, 2000

Dear Mr. Chu:

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 The qeneral controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Chu

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21 CFR 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/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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## Attachment A

Page 1 of 1

510(k) NUMBER (IF KNOWN) :_ Shijiazhuang Hongxiang Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powder Free Vinyl Patient Examination Gloves-Powder Free

A patient examination glove is disposable device intended for medical a purpose 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.)

| Concurrent of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter-Use <span style="text-decoration: overline;">X</span><br>(Optional Format 1-2-96) |

| | <div style="text-align:left"><i><span style="text-decoration: overline;">Qius. Lim</span></i></div> |
|---------------|-----------------------------------------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Dental, Infection Control,<br>and General Hospital Devices |
| 510(k) Number | <span style="text-decoration: overline;">K992821</span> |