BLACK NITRILE EXAMINATION GLOVES

K083908 · Innovative Gloves Co;, Ltd. · LZA · Mar 6, 2009 · General Hospital

Device Facts

• Record ID: K083908
• Device Name: BLACK NITRILE EXAMINATION GLOVES
• Applicant: Innovative Gloves Co;, Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between the patient and the examiner. Powder-Free examination gloves are suitable in situations where powder is not desirable.

Device Story

Disposable nitrile butadiene rubber examination glove; worn on examiner's hands to provide barrier against infectious materials and contaminants; prevents cross-contamination between patient and examiner. Used in clinical settings; intended for medical personnel. Device is black-colored; powder-free. Provides physical barrier protection.

Clinical Evidence

Bench testing only. Compliance with ASTM D 6319-00a for dimensions, physical properties, freedom from pinholes, and powder-free status. Biocompatibility testing per ISO 10993, Part 10:2002(E) for skin irritation and skin sensitization confirmed safety.

Technological Characteristics

Material: Synthetic nitrile butadiene rubber. Form factor: Disposable examination glove. Standards: ASTM D 6319-00a (physical/dimensional), ISO 10993-10 (biocompatibility). Color: Black.

Indications for Use

Indicated for use as a disposable patient examination glove, worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants. Suitable for use in situations where powder is not desirable.

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

• Nitrile Examination Glove Powder-Free (K993325)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo and contact information for Innovative Gloves Co., LTD. The logo features a stylized "IG" with a hand above the "I". The text below the logo includes the company name, address (Sanambin-BanKlang Rd., Tambon Kuanlang, Amphur Hatyai, Songkhla 90110 THAILAND), telephone numbers (TEL: [phone]), and fax numbers (FAX: [phone]).

6 2009 MAR

LAND.
K083908

# Summary of Safety And Effectiveness

### A. Information

- 1. Submitter's
Name:

Address:

Innovative Gloves Company Limited.

830 Moo 4, Sanambin -Banklang Road Kuanlang, Hatyai, Songhkla 90010, THAILAND

Telephone Number: Fax

Contact person:

2. Name of Device

Trade Name:

Device Class: Device Name:

(6674) 240132, 240195 , (6674) 240233, 474734

Mr. Rajeev Sood

Nitrile Examination Gloves Powder-Free (Black Color). 510K Number: K083908 Class I Patient examination gloves - 21 CFR 880.6250 Device Black Nitrile Powder free Examination Gloves

3. Predicate Device:

Nitrile Examination Glove Powder-Free 510K Number: K993325

### 4. Description of device

Black Nitrile Powder-Free Medical Examination

Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.

## 5. Statement of intended use,

This is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between the patient and the examiner.

Powder-Free examination gloves are suitable in situations where powder is not desirable.

6. Explanation of similarities or differences to predicate device

The proposed device is identical to the predicate device except for the following: The proposed device has been rendered black instead of natural color (510K Number: K993325)

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INNOVATIVE GLOVES CO., LTD. Sanambin-BanKlang Rd., Tambon Kuanlang, Amphur Hatyai, Songkhla 90110 THAILAND. TEL: [phone] FAX: [phone]

## B) Performance

| Non-Clinical Tests | Standard | Performance |
|--------------------------|----------------------------|-------------|
| Dimensions | ASTM D 6319-00a | Meets |
| Physical Properties | ASTM D 6319-00a | Meets |
| Freedom from pinholes | ASTM D 6319-00a | Meets |
| Powder Free | ASTM D 6319-00a | Meets |
| Clinical Tests | Standard | Performance |
| Skin Irritation Study | ISO 10993, Part 10:2002(E) | Meets |
| Skin Sensitization Study | ISO 10993, Part 10:2002(E) | Meets |

## C) Conclusion

The Nitrile Examination Gloves Powder-Free (Black Color) has been carefully compared to a legally marketed device in the 510(k). The data summaries indicate that the proposed product meets or exceeds accepted scores for the predicate product in both physical and nonclinical tests and satisfies the requirements for a safe and effective powder free medical glove.

Mohit

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rajeev K. Sood President & CEO Innovative Gloves Company, Limited 830 Moo 4, Sanambi-Ban Klang Road Kuanlang, Hatyai Songkhia 90110 THAILAND

6 2009 MAR

Re: K083908

> Trade/Device Name: Nitrile Examination Gloves Powder-Free (Black Color) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: February 17, 2009 Received: February 17, 2009

Dear Mr. Sood:

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. Sood

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.

Chistrony D. Willion

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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E GLOVES CO., LTD.

830 Moo4, Sanambin-BanKlang Road. Kuanlang, Hatyai, Songkhla 90110 THAILAND,

TEL: [phone] FAX: [phone]

# Indications for Use

510(k) Number (if known): K083908

Device Name: Nitrile Examination Gloves Powder-Free (Black Color).

A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.

Mohit

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083908