SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE

K101870 · Sunmax Vietnam Co., Ltd. · LZA · Dec 20, 2010 · General Hospital

Device Facts

• Record ID: K101870
• Device Name: SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
• Applicant: Sunmax Vietnam Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 20, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile patient examination glove; worn on examiner's hand or fingers. Acts as a physical barrier to prevent contamination between patient and examiner. Used in clinical settings by healthcare professionals. Provides protection during patient examinations. Benefits include reduced risk of cross-contamination.

Clinical Evidence

Bench testing only. Testing included dermal sensitization, primary skin irritation, permeation testing (ASTM D6978-05), iodine test, tensile strength, and barrier strength (pinholes). All tests passed and met ASTM D6319-00a requirements.

Technological Characteristics

Nitrile material; powder-free; disposable. Meets ASTM D6319-00a standards for physical specifications and dimensions. Inspection level S-2, AQL 4.0, pinholes at AQL 2.5. Biocompatible (limited duration).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-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

• Sunmax Enterprise Shanghai Co., LTD Powder free Blue Nitrile Patient Examination Glove (K090336)
• ULTRAWIN SDN BHD Non-Sterile Powder Free Nitrile Examination Gloves (K090828)
• PT. MAHAKA RYA INTI BUANA Powder Free Black Nitrile Examination gloves (K090464)

Submission Summary (Full Text)

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K101870

### 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 8807.92.

DEC 2 0 2010

# Date: March 8, 2010 Updated: November 11, 2010

### 1. Applicant:

Sunmax Vietnam Co. Ltd Km 8, Pham Van Dong Road, Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam

# 2. Manufacturer:

Sunmax Vietnam Co. Ltd Km 8, Pham Van Dong Road, Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam

### 3. Submitter:

Mr. Jigar Shah Official Correspondent for Sunmax Vietnam 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 Vietnam Co. Ltd Powder free Nitrile Patient Examination Gloves.

#### Common Names: 6. 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 Vietnam Co. Ltd Powder free Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05.

### 10. Intended Use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

# 11. Substantial Equivalence Discussion:

A powder free patient examination glove is substantially equivalent to the predicate devices.

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| Characteristic<br>and<br>parameters | Sunmax<br>Vietnam<br>Co., LTD<br>Powder Free<br>Nitrile<br>Examination<br>Glove<br>(New<br>Device) | Sunmax<br>Enterprise<br>Shanghai<br>Co., LTD<br>Powder free<br>Blue Nitrile<br>Patient<br>Examination<br>Glove tested<br>with<br>chemotherapy<br>drugs.<br>(K090336) | ULTRAWIN<br>SDN BHD<br>Non-Sterile<br>Powder Free<br>Nitrile<br>Examination<br>Gloves<br>(K 090828) | PT.<br>MAHAKA<br>RYA INTI<br>BUANA<br>Powder Free<br>Black Nitrile<br>Examination<br>gloves.<br>(K090464) | Substantially<br>Equivalence<br>Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Product Code | LZA | LZA/LZC | LZA | LZA | |
| Intended Use | A patient<br>examination<br>gloves is a<br>disposable<br>device<br>intended for<br>medical<br>purpose that<br>is worn<br>on the<br>examiner's<br>hand or<br>fingers to<br>prevent<br>contamination<br>n between<br>patient and<br>examiner. | A patient<br>examination<br>gloves<br>(Tested for<br>Use with<br>Chemotherapy Drugs) is a<br>disposable<br>device<br>intended for<br>medical<br>purpose that<br>is worn on the<br>examiner's<br>hand or<br>fingers to<br>prevent<br>contamination<br>between<br>patient and<br>examiner. | A patient<br>examination<br>gloves is a<br>disposable<br>device<br>intended for<br>medical<br>purpose that<br>is worn on<br>the<br>examiner's<br>hand or<br>fingers to<br>prevent<br>contamination<br>n between<br>patient and<br>examiner. | A powder-<br>free patient<br>examination<br>glove is a<br>disposable<br>device<br>intended for<br>medical<br>purposes that<br>is worn on<br>the<br>examiner's<br>hand or<br>finger to<br>prevent<br>contamination<br>n between<br>patient and<br>examiner. | SE |
| Width (size<br>medium) | 89 | 89 | 93-98 | 97.7 | SE |
| Overall length | 240 | 240 | 240 | 240.9 | SE |
| Palm thickness | 0.12 | 0.15 | Min 0.08 | 0.109 | Minor<br>Difference |
| Finger<br>thickness | 0.12 | 0.16 | Min 0.08 | 0.148 | Minor<br>Difference |
| Tensile<br>strength pre<br>aging min | 22 | 16.4 | 15 - 21 | 18.8 | Minor<br>Difference |
| Tensile<br>strength after<br>aging min | 23.6 | 18.2 | 14-22 | 21.3 | Minor<br>Difference |
| Ultimate<br>elongation pre<br>aging min | 500 | 510 | 550-630 | 679.4 | Minor<br>Difference |
| Ultimate<br>elongation<br>after aging | 500 | 520 | 520-610 | 767.4 | Minor<br>Difference |
| Meets<br>Biocompatibility | yes | yes | Yes | Yes | SE |
| Duration of<br>bio-<br>compatibility | Limited | Limited | Limited | Limited | SE |
| Skin irritation<br>test | Passes | Passes | Passes | Passes | SE |
| Dermal<br>sensitization | Passes | Passes | Passes | Passes | SE |
| Residual<br>powder test | Passes | Passes | Passes | Passes | SE |
| Labeling | Guidance<br>document<br>"Medical<br>Glove<br>Guidance<br>Manual" has<br>been<br>thoroughly<br>followed<br>with respect<br>to Labeling<br>of the device | Specialty<br>Medical<br>Gloves<br>Labeling | NA | NA | Minor<br>Differences |

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# KI01870

4

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# 1/01870

# 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 Vietnam Co. Ltd 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.

# 13. Conclusion:

Powder free Nitrile Patient Examination Glove 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/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Sunmax Vietnam Company, Limited C/O Mr. Jigar Shah Official Correspondent MDI Consulting, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

DEC 2 0 2000

Re: K101870

> Trade/Device Name: Powder Free Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 17, 2010 Received: November 19, 2010

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 provice
the Eaders! Found D 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. Please note: CDRF does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Register. Begister .

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Page 2- Mr. Shah

Enclosure

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 potifice: ' on'' (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.

Nams J. Osorio D.

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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### EXHIBIT #1

### Indications for Use

### 510(k) Number: K 101870

### Applicant: Sunmax Vietnam Co. Ltd

DEC 2 0 2010

Device Name: Powder Free Nitrile Patient Examination Gloves.

### Indications for Use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

# Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Elizabeth S. Clameria Willer
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101870