NITRILE EXAM GLOVE, POWDER-FREE, BLUE

K980802 · Tucker & Associates · LZA · Mar 25, 1998 · General Hospital

Device Facts

• Record ID: K980802
• Device Name: NITRILE EXAM GLOVE, POWDER-FREE, BLUE
• Applicant: Tucker & Associates
• Product Code: LZA · General Hospital
• Decision Date: Mar 25, 1998
• 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 examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Nitrile exam glove; disposable; powder-free; blue color. Worn on examiner's hand or finger; provides protective barrier; prevents contamination between patient and examiner. Used in clinical settings including dentist/doctor offices, laboratories, clinics, and hospitals. Operated by healthcare professionals.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 3578-95, ASTM D 5151 (FDA Water Leak Test), and Nitrile Glove Draft ASTM (Sept 97). Biocompatibility testing included dermal sensitization and primary skin irritation. Bio-burden testing for bacteria/mold performed.

Technological Characteristics

Nitrile material; powder-free; blue color. Complies with ASTM D 3578-95, ASTM D 5151, and Nitrile Glove Draft ASTM (Sept 97). Disposable, non-sterile form factor.

Indications for Use

Indicated for use by healthcare professionals in dentist and doctor offices, laboratories, clinics, and hospitals as a protective barrier 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

• Nitrile Exam Glove, Powder-Free, White (K974710)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Janna Tucker & Associates. The logo features a stylized figure of a Kokopelli, a fertility deity often depicted as a humpbacked flute player. The text "JANNA TUCKER & ASSOCIATES" is written in bold, sans-serif font to the right of the Kokopelli figure.

K980802

## MAR 2 5 1998

19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: [phone] Fax: [phone]

## 510(k) SUMMAR Y

| Submitted By: | Janna Tucker & Associates<br>19001 S. Richfield #185<br>Green Valley, AZ 85614<br>Phone: [phone]<br>FAX: [phone] |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Janna P. Tucker, Official Correspondent for<br>Sinochem Ningbo Latex Gloves Factory |
| Date of Submission: | 27 February 1998 |
| Device Name: | Nitrile Exam Gloves, Powder-Free, Blue |
| Proprietary Name: | (Multiple Labels) Nitrile Exam Glove, Powder Free, Blue |
| Labels/Labeling: | This device will be marketed to healthcare professionals at dentist<br>and doctor offices, laboratories, clinics and hospitals through its<br>intended use. |
| Intended Use: | A patient examination glove is a disposable device intended for<br>medical purposes that is worn on the examiner's hand or finger<br>to prevent contamination between patient and examiner. |

Substantial Equivalence:

This device is equivalent to those in commercial distribution. They are to be worn as a protective device on the examiner's hand or finger.

Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is substantially equivalent to the device manufactured by Sinochem Ningbo Latex Gloves Factory for a Nitrile Exam Glove, Powder-Free, White K974710.

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K980802

Test Results (Means This device has met or exceeded the following and/or Results): standards/tests: ASTM D 3578-95 ASTM D 5151FDA Water Leak Test (before & after aging) Nitrile Glove Draft ASTM, Sept 97. Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bio-Burden (bacteria/mold) This device is substantially equivalent to the Sinochem Ningbo Conclusions: Latex Gloves Factory device approved under K974710.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 25 1998

Sinochem Ningbo Latex Glove Factory C/O Ms. Janna P. Tucker Official Correspondent for Sinochem Ningbo Latex Glove Factory Janna Tucker & Associates 19001 South Richfield #185 Green Valley, Arizona 85614

Re : K980802 Nitrile Exam Glove, Powder-Free, Blue Trade Name: Requlatory Class: I Product Code: LZA Dated: February 27, 1998 Received: March 2, 1998

Dear Ms. Tucker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Tucker

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Whittier

Timothy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Sinochem Ningbo Latex Gloves Factory

510(K) NUMBER:

K9Y80802

DEVICE NAME:

Nitrile Exam Glove, Powder-Free, Blue

A patient examination glove is a disposable device intended for medical purposes that is I I parvate causiner's hand or finger to prevent contamination between patient and examiner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K980802

Prescription Use***_****_*
(Per 21 CFR 801.109)
OR
Over-The-Counter Use✗

(Optional Format 1-2-96)

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