SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

K011882 · Shijiazhuang Eversharp Plastic Products Co., Ltd. · LYZ · Jul 10, 2001 · General Hospital

Device Facts

• Record ID: K011882
• Device Name: SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shijiazhuang Eversharp Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 10, 2001
• 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; worn by healthcare personnel on hands/fingers. Function: barrier protection against contamination between patient and examiner. Used in clinical settings. Device conforms to ASTM D5250-00 standards for physical dimensions and integrity. Output: physical barrier. Benefit: reduced cross-contamination risk.

Clinical Evidence

No clinical data. Bench testing only: physical dimensions, water fill test (AQL 2.5), residual powder test (ASTM D6124-97), and biocompatibility (skin irritation/sensitization) testing performed.

Technological Characteristics

Material: Vinyl. Form factor: Powder-free patient examination glove. Standards: ASTM D5250-00, ASTM D6124-97. Testing: Water fill test (AQL 2.5), physical/dimension testing (AQL 4.0).

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

• Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (K992861)

Submission Summary (Full Text)

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# JUL 1 0 2001

# 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: KO1 | 882/

#### 1. Submitter's Identification:

Mr. Yinhai Wang Shijiazhuang Eversharp Plastics Products Co., Ltd. No. 312 East Long Quan Road Luquan, Hebei Province P.R. China

Date Summary Prepared: May 11, 2001

#### Name of the Device: 2.

Shijiazhuang Eversharp Plastics Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves

## 3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd.

Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (K992861)

#### 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 requirement of ASTM Standard D5250-00.

#### 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 Eversharp Plastics Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves.

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

The standards used for Shijiazhuang Eversharp Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00. 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 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 D6124-97 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:

Shijiazhuang Eversharp Plastics Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination gloves conform fully to ASTM-D-5250-00 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 0 2001

Shijiazhuang Eversharp Plastic Products Co., Ltd. C/O Mr. James Chu Official Correspondent Gloveco Incorporated 12390 East End Avenue Chino, California 91710

K011882 Re : Synthetic Powder Free (Yellow) Trade/Device Name: Vinyl Examination Gloves 880.6250 Requlation Number: Requlatory Class: I Product Code: LYZ Dated: May 18, 2001 June 18, 2001 Received:

Dear Mr. Chu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the device is ly equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, acvices markedow 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 The general controls controls provisions of the Act. provisions of the Act include requirements for annual provistration, 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. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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

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Page 2 - Mr. Chu

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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

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

KOI 1882 (IF KNOWN) : 510(k) NUMBER Shijiazhuang Eversharp Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powder Free (Yellow) 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.

Clins S. Lin

(Division Sign-Off) Division of Dental, Infection Contr and General Hospita 510(k) Number

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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