SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE

K040681 · Grand Work Plastic Products Co., Ltd. · LYZ · Jun 3, 2004 · General Hospital

Device Facts

• Record ID: K040681
• Device Name: SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 3, 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. Used by healthcare personnel in clinical settings to provide a barrier against contamination between the examiner and the patient's body, fluids, waste, or environment. Device is worn on the hand. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included physical dimensions, water-fill pinhole testing (AQL 2.5), residual powder testing (<= 2 mg/glove), and biocompatibility (primary skin irritation and sensitization).

Technological Characteristics

Synthetic vinyl material. Powder-free (residual powder <= 2 mg/glove). Complies with ASTM D5250-00E4. Physical/dimension testing per Inspection Level S-2, AQL 4.0. Pinhole testing per ASTM D5151-99, Inspection Level I, AQL 2.5. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn by healthcare personnel 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

• Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves (K000071)

Submission Summary (Full Text)

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# JUN - 3 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: _______________________________________________________________________________________________________________________________________________

#### 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 (White) Vinyl Patient Examination Gloves—Powder Free

#### 3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves (K000071)

#### 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 D5250-00E4.

#### 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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K040681

#### 6. Comparison to Predicate Devices:

Grand Work Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free, is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) 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 (Whitc) 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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2004

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

Re: K040681

Ro40001 Gloves--Powder Free Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 28, 2004 Reccived: May 20, 2004

Dear Mr. Chu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became or ============================================================================================================================================== 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 Interstate commerce prior to they been reclassified in accordance with the provisions of Allichunches, or to ab rises 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (FWA), it may of subjoct to have of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the South nouncements 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 Please be auvisou that 1 DTS issuates on that your device complies with other requirements mean that I DA nas made a actes and regulations administered by other Federal agencies. of the Act of ally I ederal bakes and equirements, including, but not limited to: registration You must comply with an the Fiseling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), idocling (21 CFR Part 820); and if requirelitents as set forth in the quality by rovisions (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) IThis letter will anow Jourte over mailing of substantial equivalence of your device to a premarket nonfication. The PDF milang or sassification 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), If you desire specific acrise for your de at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). You may obtain other general information on your responsibilities under the Act from the Inay outain 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,

Ques

Chiu Lin, Ph.D Dircctor 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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## Attachment A

Page 1 of 1

0406 510(k) NUMBER (IF KNOWN) :_ Grand Work Plastics Products Co., Ltd. DEVICE NAME: DEVICE NAME:

A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's s
een and the circuins in the closed setimal examiner A patient examination glove is disposaolo device institution 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 | X |
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(Optional Format 1-2-96)

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

| 510(k) Number: | K040681 |
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