POWDERED (WHITE) VINYL PATIENT EXAMINATION

K070027 · Shijiazhuang Lianhe Shunda Plastic Products Co., L · LYZ · Mar 22, 2007 · General Hospital

Device Facts

• Record ID: K070027
• Device Name: POWDERED (WHITE) VINYL PATIENT EXAMINATION
• Applicant: Shijiazhuang Lianhe Shunda Plastic Products Co., L
• Product Code: LYZ · General Hospital
• Decision Date: Mar 22, 2007
• 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 vinyl patient examination glove; worn by healthcare personnel on hands/fingers; acts as physical barrier to prevent cross-contamination between patient and examiner; used in clinical settings; provides protection against body fluids, waste, and environmental contaminants.

Clinical Evidence

No clinical data. Bench testing only. Testing included physical and dimension testing per ASTM D-5250-00E4, FDA 1000 ml water fill test (AQL 2.5), primary skin irritation and sensitization testing, and residual powder testing per ASTM D-6124-06.

Technological Characteristics

Material: Vinyl. Standard: ASTM D-5250-00E4. Form factor: Disposable patient examination glove. Powdered (residual powder <= 10mg/dm2 per ASTM D-6124-06).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-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 Powdered (White) Vinyl Patient Examination Gloves (K000166)

Submission Summary (Full Text)

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EXHIBIT #1 Page 1 of 2

### 510(K) SUMMARY

MAR 2 2 2007

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: K070027

### l. Submitter's Identification:

Mr. Li Quanfu Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Nanwuhui Village, Yuanshi County, Shijiazhuang, Hebei, China 051130

Date Summary Prepared: September 20, 2006

### 2. Name of the Device:

Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves

#### 3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)

## 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.

### 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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### 6. Comparison to Predicate Devices:

Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves.

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

The standards used for Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00 =4. 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.

A Residual Powder Test that based on ASTM D-6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powdered" claims (contain no more than 10mg/dm4).

### 8. Labeling:

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

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

Not Applicable - There is no hypoallergenic Claim.

### 10. Conclusions:

Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves 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 logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a symbol. The symbol consists of four stylized human figures, represented by curved lines, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Lianhe Shunda Plastic Products Company Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710

MAR 2 2 2007

Re: K070027

Trade/Device Name: Powdered (White) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 12, 2007 Received: March 13, 2007

Dear Ms. Liu:

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 - Ms. Liu

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 your 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/industry/support/index.html.

Sincerely yours,

Clus

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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# INDICATION FOR USE

510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:

10700 77 Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves

# INDICATIONS FOR USE:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Per 21 CFR 801.109) OR

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

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

Howard Sheila R. Murphy, MD

tion Control
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