POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K083015 · Zibo Goldenline Plastic Product Co., Ltd. · LYZ · Mar 10, 2009 · General Hospital

Device Facts

• Record ID: K083015
• Device Name: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
• Applicant: Zibo Goldenline Plastic Product Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 10, 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 gloves; non-sterile; powder-free. Worn by healthcare personnel during patient examinations to provide barrier protection against fluids, waste, and environmental contaminants. Prevents cross-contamination between examiner and patient. Manufactured to meet ASTM D5250-00 standards for physical dimensions and integrity. Used in clinical or medical settings.

Clinical Evidence

Bench testing only. Testing included physical and dimension testing (ASTM D5250-00, Inspection Level S-2, AQL 2.5), FDA 1000 ml water fill test (Inspection Level I, AQL 2.5), and biocompatibility testing (primary skin irritation and skin sensitization). No clinical data provided.

Technological Characteristics

Synthetic vinyl material. Meets ASTM D5250-00 standards. Powder-free (contains no more than 2 mg powder per glove). Non-sterile. Physical dimensions and integrity verified via water fill testing and AQL sampling.

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable barrier worn on hands or fingers 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 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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MAR 1 0 2009

# 510 (K) SUMMARY

# KO83015

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

#### 1. Submitter's Identification:

Mr. Cong Feng Zhao Zibo Goldenline Plastic Products Co., Ltd. Siji Road, Zhangdian District Zibo, Shandong, China Date summary prepared: October 7, 2008

## 2. Name of the Device:

Zibo Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free

# 3. Predicate Device Informaton:

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 D5250-00.

## 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.

## 6. Comparison to Predicate Devices:

Zibo Goldenline 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 Zibo Goldenline Plastic 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, 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:

Zibo Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free 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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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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.

MAR 1 0 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zibo Goldenline Plastic Products Company, Limited C/o Mr. John Zhao Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

K083015 Re:

Trade/Device Name: Patient Vinyl Examination Gloves, Powder-free,

Non-Sterile

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 12, 2009 Received: February 17, 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 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Syste Y. Mchane O M.D.

Ginette Y. Michaud, M.D. 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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# Zibo Goldenline Plastic Products Co., Ltd. Siji Road, Zhangdian District Zibo, Shandong, China

# INDICATIONS FOR USE

Zibo Goldenline Plastic Products Co., Ltd. Applicant:

510(k) Number:

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile Device Name:

Indications of Use:

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

Prescription Use

Over the Counter Use X

Factory Initials

St. Murphy B

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anoother of Antal Devices

510(k) Number: KOSC