SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE

K071072 · Shanghai China Star Corp · LZA · Aug 30, 2007 · General Hospital

Device Facts

• Record ID: K071072
• Device Name: SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
• Applicant: Shanghai China Star Corp
• Product Code: LZA · General Hospital
• Decision Date: Aug 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or to prevent finger examiner. These gloves are not intended to be used as a chemical barrier

Device Story

Disposable powder-free blue nitrile patient examination glove; worn on examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with chemotherapy drugs per ASTM D 6978-05. Used in clinical settings by healthcare providers. Provides a physical barrier; does not serve as a chemical barrier. Benefits include protection against contamination during medical examinations.

Clinical Evidence

Bench testing only. Testing included dermal sensitization, primary skin irritation, permeation testing per ASTM D 6978-05, iodine testing, tensile strength, and barrier strength (pinholes). All tests passed requirements of ASTM D 6319-00a-2005.

Technological Characteristics

Material: Nitrile; powder-free. Dimensions: 240mm length, 92mm width (medium). Thickness: 0.17mm (palm), 0.18mm (finger). Standards: ASTM D 6319-00a-2005, ASTM D 6978-05 (chemotherapy permeation). Biocompatibility: Passes skin irritation and dermal sensitization tests. AQL 4.0 for physical specs, AQL 2.5 for pinholes.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Not intended for use as a chemical barrier.

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

• MEDLINE INDUSTRIES, INC (K040841)
• ALLEGIANCE HEALTHCARE CORP. (K022765)

Submission Summary (Full Text)

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# SHANGHAI CHINASTAR COR

No#283 Che Xin Rd, Che Dun Zhen, Song Jaing County Shanghai, China C/O: 11F No.201, Nanking East Rd., Sec 3, Taipei, Taiwan, R.O.C Tel:[phone] Fax:[phone]

510(k) Summary

K071072

Prepared: March 28, 2007

| Applicant | Shanghai China Star Corp<br>No. 283, Che Xing Road, Che Dun Zhen,<br>Song Jiang<br>County: Shanghai, China |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shanghai China Star Corp<br>No. 283, Che Xing Road, Che Dun Zhen,<br>Song Jiang<br>County: Shanghai, China |
| Submitter | Romil Rambhia<br>Official Correspondent for<br>Shanghai China Star Corp |
| Address | mdi Consultants, Inc.<br>55 Northern Blvd., Suite 200<br>Great Neck, New York 11021<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Trade/proprietary Name | Shanghai China Star Corp<br>Powder free Blue Nitrile Patient<br>Examination Glove tested with<br>chemotherapy drugs. |
| Common Names | POWDER-FREE Patient Examination<br>Glove |
| Classification name | Patient Examination Glove |
| Classification number | 21 CFR 880.6250 |

## Device Description:

Shanghai China Star Corp Powder free blue Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device powdered with absorbable dusting powder that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.

#### Intended Use:

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or to prevent finger examiner. These gloves are not intended to be used as a chemical barrier

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# Substantial Equivalence Discussion:

| Characteristic<br>and parameters | Shanghai China Star<br>Corp<br>(New Device) | MEDLINE<br>INDUSTRIES, INC<br>(K) 040841 | ALLEGIANCE<br>HEALTHCARE<br>CORP.<br>(K) 022765 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA | LZA |
| Intended Use | A powder free patient<br>examination glove<br>(Tested for Use with<br>Chemotherapy Drugs)<br>is a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiners hand<br>or finger to prevent<br>contamination between<br>patient and examiner.<br>These gloves are not<br>intended to be used as a<br>chemical barrier | Medline Powder-Free<br>Blue Nitrile<br>Examination Gloves<br>(Tested for Use with<br>Chemotherapy<br>Drugs) is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. In addition,<br>these gloves are worn<br>to protect the wearer<br>against exposure to<br>chemotherapy drugs.<br>The gloves with tested<br>for use with<br>chemotherapy drugs<br>labeling claims. |
| Width (size<br>medium) | 92mm | 92mm | N/A |
| Overall length | 240mm | 240mm | N/A |
| Palm thickness | 0.17mm | 0.17mm | N/A |
| Finger thickness | 0.18mm | 0.18mm | N/A |
| Tensile strength<br>pre aging min | 21mpa | 21mpa | N/A |
| Tensile strength<br>after aging min | 16mpa | 16mpa | N/A |
| Ultimate<br>elongation pre<br>aging min | 500 | 500 | N/A |
| Ultimate<br>elongation after<br>aging min | 500 | 500 | N/A |
| Meets<br>Biocompatibility<br>standards | Yes | Yes | Yes |
| Duration of bio-<br>compatibility | Limited | Limited | Limited |
| Skin irritation test | Passes | Passes | Passes |
| Dermal<br>sensitization | Passes | Passes | Passes |
| Residual powder<br>test | Passes | Passes | Passes |

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is substantially equivalent to the predicate devices.

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N/A is we don't know the specifications.

### Summary of Testing:

| Test | Results |
|------------------------------------------|------------------------------------------------------|
| 1. Dermal Sensitization Test | Passes |
| 2. Primary Skin irritation | Passes |
| 3. Permeation testing per ASTM D 6978-05 | Passes |
| 4. Iodine Test | Passes |
| 5. Tensile strength | Gloves meets the requirements of<br>ASTM D63 19-00a. |
| 6. Barrier strength | Gloves meets the requirements of<br>ASTM D63 19-00a. |

The standards used by Shanghai Chinstar Corp to determine substantial equivalence are based on ASTM D 631900a-2005. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5

There are no special labeling claims and we do not claim our gloves to be hypoallergenic.

#### Conclusion:

Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs performance was equivalent to any other conventional method evaluated. Our evaluation concluded that our device raises no new issues of Safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized eagle with three overlapping profiles, symbolizing health, services, and people. The eagle is a common symbol of the United States, representing freedom and strength.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai China Star Corporation C/O Mr. Romil Rambhia Official Correspondent mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11001

AUG 3 0 2007

Re: K071072

Trade/Device Name: Shanghai China Star Corp Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 21, 2007 Received: August 22, 2007

Dear Mr. Rambhia:

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. Rambhia

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 vour 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/dsma/dsmamain.html

Sincerely yours,

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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## Indications for Use

510(k) Number (if known): Not Assigned as of now

1/07/072

Applicant: Shanghai China Star Corp

Device Name: Shanghai China Star Corp Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs.

#### Indications for Use:

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Shula A Murphy, 6

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(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K021072