POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K092820 · Shijiazhuang Fuhao Plastic Products Co., Ltd. · LYZ · Dec 3, 2009 · General Hospital

Device Facts

• Record ID: K092820
• Device Name: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shijiazhuang Fuhao Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 3, 2009
• 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; non-sterile; non-colored. Worn by healthcare personnel during patient examinations to provide barrier protection against contamination from body fluids, waste, or the environment. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical settings; operated by healthcare professionals. Benefits include reduction of cross-contamination risk between patient and examiner.

Clinical Evidence

Bench testing only. Testing included physical dimensions, 1000 ml water-fill pinhole test (AQL 2.5), and biocompatibility (primary skin irritation and skin sensitization). No clinical data provided.

Technological Characteristics

Synthetic vinyl material; powder-free (max 2 mg powder/glove). Complies with ASTM D5250-06. Non-sterile, non-colored. Physical barrier principle. No energy source, software, or connectivity.

Indications for Use

Indicated for use by healthcare personnel on 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 Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)

Reference Devices

• Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves

Submission Summary (Full Text)

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# 5/0(k)#:K092820

### 510 (K) SUMMARY

DEC - 3 2009

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.

#### 1. Submitter's Identification:

Shijiazhuang Fuhao Plastic Products Co., Ltd. North Zhangcheng Village, South Zhangcheng Town, Jingxing, Shijiazhuang, China

Date summary prepared: September 9, 2009

#### 2. Name of the Device:

:

Shijiazhuang Fuhao Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free

#### Predicate Device Informaton: 3.

Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)

#### 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, 80LYZ. and meets all requirement of ASTM Standard D5250-06.

#### પં 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.

#### 6. Comparison to Predicate Devices:

Shijiazhuang Fuhao Plastic Products Co., Ltd.Synthetic Vinyl Patient Examination Gloves, Powder-Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. and Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Powderfree.

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

The standards used for Shijiazhuang Fuhao Plastic Products Co., Ltd.glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves. Inspection Level S-2. AOL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 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 is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

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

Not Applicable -- There is no hypoallergenic claim.

#### 9. Conclusions:

Shijiazhuang Fuhao Plastic Products Co., Ltd.Synthetic Vinyl Patient Examination Gloves, Powder-Free conform fully to ASTM-D-5250-06 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 a human figure with outstretched arms, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Shijiazhuang Fuhao Plastic Products Company, Limited C/O Mr. John Zhao Official Correspondent Basic Medical Industries, Incorporated 12390 East End Avenue DEC - 3 2009 Chino, California 91710

Re: K092820

Trade/Device Name: Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: October 2, 2009 Received: October 28, 2009

Dear Mr. Zhao:

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 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. Zhao

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anton V. Marton

Susan Runner, D.D.S., M.A. Acting 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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### SHIJIAZHUANG FUHAO PLASTIC PRODUCTS CO., LTD.

North Zhangcheng Village, South Zhangcheng Town, Jingxing, Shijiazhuang Fax: [phone] Phone: [phone]

### INDICATIONS FOR USE

## 510 (k)# K092820

Shijiazhuang Fuhao Plastic Products Co., Ltd. Applicant:

510(k) Number:

Patient Vinyl Examination Gloves, Powder free. Non-Sterile, Device Name: Non Colored

Indications of Use:

A patient examination glove is a disposable device intended for medical purposes that is A pation chanimation gr s hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Factory Initials

Elizabeth B. Clavin Will

of Anesthesiology, General Hoapita tion Control, Dental Devices

510(k) Number: