SYNTHETIC, POWDER-FREE NITRILE EXAMINATION

K102593 · Zibo Yinghao Medical Products Co., Ltd. · LYZ · Dec 20, 2010 · General Hospital

Device Facts

• Record ID: K102593
• Device Name: SYNTHETIC, POWDER-FREE NITRILE EXAMINATION
• Applicant: Zibo Yinghao Medical Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 20, 2010
• 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 nitrile patient examination glove; blue color; powder-free. Worn by healthcare personnel or similar users on hands/fingers during patient examinations. Acts as a physical barrier to prevent cross-contamination between the examiner and the patient's body, fluids, waste, or environment. Non-sterile. Used in clinical or general medical settings. Provides protection through material barrier properties.

Clinical Evidence

No clinical data. Bench testing only: physical and dimensions testing (ASTM D6319-05, 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).

Technological Characteristics

Material: Synthetic nitrile. Form factor: Powder-free, blue, non-sterile examination glove. Standards: Conforms to ASTM D6319-05. Biocompatibility: Tested for skin irritation and sensitization. Powder content: < 2 mg per glove.

Indications for Use

Indicated for use as a disposable medical glove worn on the hands or fingers of healthcare personnel or similar users to prevent cross-contamination between the patient and the 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

• Sunmax Enterprise Shanghai Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K090336)

Reference Devices

• Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves

Submission Summary (Full Text)

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# 11102593

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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:

Zibo Yingbo Medical Products Co., Ltd. Qilu Chemical Industry Park Zhangdian District, Zibo, Shandong, China

DEC 2 0 2010

Date summary prepared: Nov. 24, 2010

#### 2. Name of the Device:

Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color

#### 3. Predicate Device Informaton:

Sunmax Enterprise Shanghai Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K090336)

#### 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250. Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.

#### Intended Use: ર્જ

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.

#### Comparison to Predicate Devices: 6.

Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder-Free, Blue Color are substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Nitrile Patient Examination Gloves and Tangshan Zhonghong Pulin Group Co., Ltd. Powder -Free Nitrile Patient Examination Gloves.

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KI02593

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

The standards used for Zibo Yingbo Medical Products Co., Ltd. glove production are based on ASTM-D-6319-05. 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 Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder-Free, Blue Color conform fully to ASTM-D-6319-05 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Zibo Yingbo Medical Products Company, Limited C/O Mr. Frank Liu President Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

Re: K102593

Trade/Device Name: Patient Nitrile Examination Gloves, Powder Free Non-Sterile, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 24, 2010 Received: November 29, 2010

FEB 22 2011

Dear Mr. Liu:

This letter corrects our substantially equivalent letter of December 20, 2010.

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 (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. 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); 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/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony V. as

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Zibo Yingbo Medical Products Co., Ltd.

Qilu Chemical Industry Park Zhangdian District, Zibo, Shandong, China

K102593

## INDICATIONS FOR USE

Applicant: Zibo Yingbo Medical Products Co., Ltd.

510(k) Number:

Patient Nitrile Examination Gloves, Powder free, Non-Sterile, Device Name: Blue Color . . . . . . . :

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

Elizabeth F. Plamie-Welle

(Division Sign-Off) (Division Olgh Oly), General Hospital Infection Control, Dental Devices

510(k) Number: K102593