NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE

K974710 · Sinochem Ningbo Latex Gloves Factory · LZA · Feb 25, 1998 · General Hospital

Device Facts

• Record ID: K974710
• Device Name: NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
• Applicant: Sinochem Ningbo Latex Gloves Factory
• Product Code: LZA · General Hospital
• Decision Date: Feb 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; powder-free; white. Disposable protective barrier worn on examiner's hand or finger. Used in clinical settings (dentist/doctor offices, labs, hospitals) by healthcare professionals. Prevents contamination between patient and examiner. Device functions as a physical barrier; no electronic or active components.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 3578-95 and ASTM D 5151 standards. Additional testing included FDA water leak tests (pre- and post-aging), dermal sensitization, primary skin irritation, and bio-burden (bacteria/mold) assessment.

Technological Characteristics

Nitrile material; powder-free; white. Complies with ASTM D 3578-95 (standard specification for rubber examination gloves) and ASTM D 5151 (standard test method for detection of holes in medical gloves).

Indications for Use

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

• Influx Pacific SDN. BHD. Nitrile Exam Glove, Powdered (K970216)

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 Kokopelli figure on the left. The text "JANNA TUCKER & ASSOCIATES" is written in a bold, sans-serif font to the right of the figure.

FEB 2 5 1998

# 510(k) SUMMARY

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

Submitted Bv:

Janna Tucker & Associates 19001 S. Richfield #185 Green Valley, AZ 85614 520-625-2904 Phone: FAX: [phone]

Contact Person: Janna P. Tucker, Official Correspondent for Sinochem Ningbo Latex Glove Factory

Date of Submission: 16 December 1997

Device Name: Nitrile Exam Gloves, Powder-Free, White

Proprietary Name: (Multiple Labels) Nitrile Exam Glove, Powder Free

Labels/Labeling: This device will be marketed to healthcare professionals at dentist. and doctor offices, laboratories, clinics and hospitals through its intended use.

A patient examination glove is a disposable device intended for Intended Use: medical purposes that is worn on the examiner's hand or finger 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 Influx Pacific SDN. BHD. K970216 for a Nitrile Exam Glove, Powdered,

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Test Results (Means and/or Results):

This device has met or exceeded the following standards/tests:

ASTM D 3578-95 ASTM D 5151 FDA Water Leak Test (before & after aging) Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bio-Burden (bacteria/mold)

Conclusions:

This device is substantially equivalent to the Influx Pacific SDN. BHD. device approved under K970216.

EXHIBIT M
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EEB 2 5 1998

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

K974710 Re : Nitrile Exam Glove, Powder-Free/White Trade Name: Regulatory Class: I Product Code: LZA Dated: January 19, 1998 Received: January 26, 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 The general controls provisions of the Act 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 (Premarket Approval), it may Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Tucker

through 542 of 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 regulation (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 premarket notification" (21 CFR 807.97). 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,

Patricia Crassitoffer

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

Enclosure

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## INDICATIONS FOR USE

| APPLICANT: | Sinochem Ningbo Latex Glove Factory |
|----------------|-------------------------------------|
| 510(K) NUMBER: | K974710 |
| DEVICE NAME: | Nitrile Exam Glove, Powder-Free |

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chùm S. Lim

(Division Sign-Off)
Division of Dental, Infection Control,

510(k) Nu

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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