SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE

K040682 · Grand Work Plastic Products Co., Ltd. · LYZ · Jul 28, 2004 · General Hospital

Device Facts

• Record ID: K040682
• Device Name: SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 28, 2004
• 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

Disposable synthetic vinyl patient examination glove; powder-free. Worn by healthcare personnel on hands/fingers during patient examinations. Acts as physical barrier to prevent cross-contamination between examiner and patient body, fluids, waste, or environment. Used in clinical settings. No electronic or mechanical components.

Clinical Evidence

Bench testing only. Includes physical and dimension testing (ASTM D5250-00E4, AQL 4.0), water-fill pinhole testing (ASTM D5151-99, AQL 2.5), and residual powder testing (ASTM D6124-01, <2 mg/glove). Biocompatibility testing confirmed no primary skin irritation or sensitization.

Technological Characteristics

Synthetic vinyl material. Powder-free (residual powder <2 mg/glove). Meets ASTM D5250-00E4 standards for physical dimensions and properties. Tested per ASTM D5151-99 for pinholes. Biocompatible per skin irritation/sensitization testing.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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

• Shijiazhuang Great Vision Plastic Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves (K992555)

Submission Summary (Full Text)

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# JUL 28 2004

# 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: K040682

### 1. Submitter's Identification:

Mr. Shuangzu Ma Grand Work Plastics Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China

Date Summary Prepared: March 01, 2004

### 2. Name of the Device:

Grand Work Plastics Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powder Free

#### 3. Predicate Device Information:

Shijiazhuang Great Vision Plastic Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves (K992555)

### 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00€4.

#### 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:

Grand Work Plastics Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powder Free, is substantially equivalent in safety and effectiveness to the Shijiazhuang Vision Plastic Products Co., Ltd. Synthetic 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 Grand Work Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00E4. 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 based on ASTM D-5151-99 was also conducted with samplings of AQL 2.5, Inspection Level I, 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 Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

## 8. Discussion of Clinical Tests Performed:

Not Applicable -- There is no hypoallergenic Claim.

### 9. Conclusions:

Grand Work Plastics Co., Ltd. Synthetic (White) Vinyl Patient Examination gloves— Powder Free conform fully to ASTM-D-5250-00E4 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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 2004

Grand Work Plastic Products Company Limited C/O Mr. James Chu GLOVECO, Incorporated 590 West Central Avenue #D Brea, California 92821

Re: K040682

Trade/Device Name: Synthetic Vinyl Patient Examination Gloves-Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 18, 2004 Received: May 24, 2004

Dear Mr. Chu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chu

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Grand Work Plastics Products Co., Ltd. Device Name:_ Synthetic Vinyl Patient Examination Gloves - Powder-Free ______________________________________________________________________________________________________________________________________________________________________________

Indications For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ﮯ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rolen Marley

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: 040682