SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES

K992797 · Shijiazhuang Hongxiang Plastics Products Co., Ltd. · LYZ · Nov 5, 1999 · General Hospital

Device Facts

• Record ID: K992797
• Device Name: SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shijiazhuang Hongxiang Plastics Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 5, 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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Synthetic powdered vinyl patient examination gloves; disposable barrier device. Worn on hands of healthcare personnel during patient examinations. Function: prevent cross-contamination between patient and examiner/environment. Input: none (passive physical barrier). Output: none. Used in clinical settings. Benefit: infection control via physical barrier.

Clinical Evidence

Bench testing only. Testing included physical and dimension testing (ASTM D5250-92, AQL 4.0), FDA 1000 ml water fill test (AQL 2.5), and primary skin irritation and sensitization testing. No clinical data provided.

Technological Characteristics

Material: Synthetic vinyl. Powdered with absorbable dusting powder (USP). Design: Disposable patient examination glove. Standards: ASTM D5250-92. Testing: Physical/dimension testing (Inspection Level S-2, AQL 4.0), water fill test (Inspection Level S-4, AQL 2.5), biocompatibility (skin irritation/sensitization).

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable barrier worn on the hand or finger to prevent contamination between the patient and the 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

• Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves (K960746)
• Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves (K974151)

Submission Summary (Full Text)

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NOV - 5 1999

# 510(K) SUMMARY

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:

Ms. Guixi Liu Shijiazhuang Hongxiang Plastics Products Co., Ltd. Lu Quan City, New High Technologies Industrial Zone Shijaizhuang, Hebei Province P.R. China

Date Summary Prepared: July 29, 1999

#### Name of the Device: 2. -

Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves

#### 3. Predicate Device Information:

Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves, K#960746 Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves, K#974151

#### 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III 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 Powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves and the Shanghai Super Gloves Company, Ltd. Powder Vinyl Patient Examination Gloves.

#### Discussion of Non-Clinical tests Performed for Determination of Substantial 7. 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, AQL 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.

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

Not Applicable - There is no hypoallergenic Claim.

## 9. Conclusions:

Shijiazhuang Hongxiang Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powdered) 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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Image /page/2/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 a stylized image of three birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

Shijiazhuang Hongxiang Plastics Products Co., Ltd. c/o Ms. Karen Abell Official Correspondent for Shijiazhuang Hongxiang Plastics Products Co., Ltd. Basic Medical Industries, Inc. 12390 East End Avenue Chino, California 91710

Re : K992797 Synthetic Powdered Vinyl Patient Examination Trade Name: Gloves Regulatory Class: I . . . . Product Code: LYZ Dated: July 29, 1999 Received: August 19, 1999

Dear Ms. Abell:

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 general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Ms. Abell

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 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 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" (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,

Kilitaturski
Timothy A. Ulatowski

thy 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

(IF KNOWN) : _ 510(k) NUMBER

Shijiazhuang Hongxiang Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powdered Vinyl Patient Examination Gloves-Powdered

A patient examination glove is 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.)

| Concurrent of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
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| | | (Optional Format 1-2-96) |

| (Division Sign-Off) |
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Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K992797 |
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