SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS

K090336 · Sunmax Enterprise Shanghai Co. , Ltd. · LZA · Jul 1, 2009 · General Hospital

Device Facts

• Record ID: K090336
• Device Name: SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
• Applicant: Sunmax Enterprise Shanghai Co. , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 1, 2009
• 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 finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

Device Story

Disposable blue nitrile patient examination glove; worn on examiner's hand or finger to prevent cross-contamination between patient and examiner. Device tested for permeation resistance against specific chemotherapy drugs (e.g., Dacarbazine, Cyclophosphamide, Doxorubicin, Fluorouracil, Cisplatin, Etoposide, Paclitaxel, Thio-Tepa, Carmustine) per ASTM D 6978-05. Used in clinical or medical settings by healthcare providers. Provides a physical barrier; not intended for use as a chemical barrier. Benefits include protection against contamination during patient 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 and met ASTM D6319-00a requirements.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free, blue, disposable examination glove. Standards: ASTM D 6319-00a, ASTM D 6978-05. Physical properties: 18 MPa tensile strength (pre/post-aging), 0.12mm palm/finger thickness. Non-sterile.

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. Tested for use with specific chemotherapy drugs.

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

• Shanghai China Star Corp (K071072)
• MEDLINE INDUSTRIES, INC (K040841)

Submission Summary (Full Text)

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K090336

#### EXHIBIT #3

# 510(k) Summary

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

## 1. Applicant:

Sunmax Enterprise Shanghai Co., Ltd No.2 New Industrial Area, Zhu Hang Zhen Jin Shan Xian, Shanghai, China

JUL - 1 2009

2. Manufacturer: Sunmax Enterprise Shanghai Co., Ltd No.2 New Industrial Area, Zhu Hang Zhen Jin Shan Xian, Shanghai, China

### 3. Submitter:

Mr. Jigar Shah Official Correspondent for Sunmax Enterprise Shanghai Co., Ltd

#### 4. Address:

mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: [phone] Fax: [phone] [e-mail]

#### 5. Trade/proprietary Name:

Sunmax Enterprise Shanghai Co Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs.

- 6. Common Names: POWDER-FREE Patient Examination Glove
## 7. Classification name: Patient Examination Glove

- 8. Classification number: 21 CFR 880.6250

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## 9. Device Description:

Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.

## 10. 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 finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

## 11. Substantial Equivalence Discussion:

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

| Characteristic<br>and parameters | Sunmax<br>Enterprise<br>Shanghai Co.,<br>LTD (New<br>Device) | Shanghai China<br>Star Corp<br>(K) 071072 | MEDLINE<br>INDUSTRIES,<br>INC<br>(K) 040841 | Substantial<br>Equivalence<br>(SE) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | LZA | |
| Intended Use | A powder free<br>patient<br>examination<br>glove (Tested<br>for Use with<br>Chemotherapy<br>Drugs) is a<br>disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiners hand<br>or finger to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>These gloves<br>are not intended<br>to be used as a<br>chemical barrier | A powder free<br>patient<br>examination<br>glove (Tested for<br>Use with<br>Chemotherapy<br>Drugs) is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on<br>the examiners<br>hand or finger to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>These gloves are<br>not intended to be<br>used as a<br>chemical barrier | Medline<br>Powder-Free<br>Blue Nitrile<br>Examination<br>Gloves (Tested<br>for Use with<br>Chemotherapy<br>Drugs) is a<br>disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's hand<br>or finger to<br>prevent<br>contamination<br>between patient<br>and examiner. | SE |
| Width (size<br>medium) | 89mm | 92mm | 92mm | Minor<br>difference |

2

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| Overall length | 240mm | 240mm | 240mm | SE |
|-------------------------------------------|---------|---------|---------|---------------------|
| Palm thickness | 0.12mm | 0.17mm | 0.17mm | |
| Finger thickness | 0.12mm | 0.18mm | 0.18mm | |
| Tensile strength<br>pre aging min | 18mpa | 21mpa | 21mpa | |
| Tensile strength<br>after aging min | 18mpa | 16mpa | 16mpa | |
| Ultimate<br>elongation pre<br>aging min | 600 | 500 | 500 | Minor<br>difference |
| Ultimate<br>elongation after<br>aging min | 570 | 500 | 500 | |
| Meets<br>Biocompatibility | Yes | Yes | Yes | |
| Duration of bio-<br>compatibility | Limited | Limited | Limited | |
| Skin irritation test | Passes | Passes | Passes | SE |
| Dermal<br>sensitization | Passes | Passes | Passes | |
| Residual powder<br>test | Passes | Passes | Passes | |

12. Summary of Testing:

| | Test | Results |
|----|---------------------------------------|------------------------------------------------------|
| a. | Dermal Sensitization Test | Passes |
| b. | Primary Skin irritation | Passes |
| c. | Permeation testing per ASTM D 6978-05 | Passes |
| d. | Iodine Test | Passes |
| e. | Tensile strength | Gloves meets the requirements of<br>ASTM D63 19-00a. |
| f. | Barrier strength | Gloves meets the requirements of<br>ASTM D63 19-00a. |

The standards used by Sunmax Enterprise Shanghai Co 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.

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# 13. 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/4/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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.

#### Public Health Service

JUL - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sunmax Enterprise Shanghai Company, Limited C/O Mr. Jigar Shah mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K090336

Trade/Device Name: Powder-Free, Blue, Nitrile Examination Gloves Tested with

Chemotherapy Drugs

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: June 25, 2009 Received: June 30, 2009

Dear Mr. Shah:

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. Shah

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections \$31-542 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D.m
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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### EXHIBIT #1

#### Indications for Use

# 510(k) Number (if known): K090336

# Applicant: Sunmax Enterprise Shanghai Co Ltd

Device Name: 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.

# Chemotherapy drugs with their breakthrough times:

| Dacarbazine | 240 minutes |
|---------------------------|--------------|
| Cyclophosphamide(Cytoxan) | 240 minutes |
| Doxorubicin Hydrochloride | 240 minutes |
| Fluorouracil | 240 minutes |
| Cisplatin | 240 minutes |
| Etoposide (Toposar) | 240 minutes |
| Paclitaxel (Taxol) | 240 minutes |
| Thio-Tepa | 23.3 minutes |
| Carmustine | 18.7 minutes |

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (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)

Shule A Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090336