NITRILE EXAM GLOVE, POWDER FREE

K980677 · Ningbo Yujiang Plastic & Rubber Co. , Ltd. · LZA · Mar 16, 1998 · General Hospital

Device Facts

• Record ID: K980677
• Device Name: NITRILE EXAM GLOVE, POWDER FREE
• Applicant: Ningbo Yujiang Plastic & Rubber Co. , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 16, 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 examination glove; disposable; worn on examiner's hand or finger. Used in dental/doctor offices, laboratories, clinics, and hospitals. Acts as physical barrier to prevent cross-contamination between patient and examiner. Protects healthcare personnel and patients during medical examinations.

Clinical Evidence

Bench testing only. Device met or exceeded ASTM D 3578-95 and ASTM D 5151 standards. Additional testing included FDA water leak test (before and after aging), biocompatibility, dermal sensitization, primary skin irritation, and bio-burden (bacteria/mold) analysis.

Technological Characteristics

Nitrile material; powder-free; disposable. Complies with ASTM D 3578-95 and ASTM D 5151. Tested for biocompatibility, dermal sensitization, primary skin irritation, and bio-burden.

Indications for Use

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

• 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 figure of Kokopelli, a fertility deity, playing a flute. The text "JANNA TUCKER & ASSOCIATES" is written in bold, uppercase letters to the right of the figure.

MAR 1 6 1998

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

510(k) SUMMARY

K980677

| Submitted By: | |
|---------------|--|
| | |

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

- Janna P. Tucker, Official Correspondent for Contact Person: Ningbo Yujiang Plastic & Rubber Co. Ltd.
17 February 1998 Date of Submission:

Nitrile Exam Gloves, Powder-Free Device Name:

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

- This device will be marketed to healthcare professionals at dentist, Labels/Labeling: 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 Intlux 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1998 Ningbo Yujiang Plastic & Rubber Company, Ltd. C/O Janna Tucker & Associates 19001 S. Richfield #185 85614 Green Valley, Arizona

K980677 Re : Nitrile Examination Glove, Powder Free Trade Name: Requlatory Class: I Product Code: LZA February 17, 1998 Dated: Received: February 20, 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 be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. . ਉੱ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice_requirement , as set ...... forth in the Quality System Regulation (QS) for Medical General requlation (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 Chrough 542 Of the ace as rought ons, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborny of substantial equivalence of your device to a legally rinding of bubbeandian oquresults in a classification for your marketed predicate actro 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 che regulation Chercred, "Mirranan") 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,

Patrici Cucenati/for

Timothy A. Ulatowski 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

| APPLICANT: | NINGBO YUJIANG PLASTIC & RUBBER CO LTD. |
|----------------|-----------------------------------------|
| 510(K) NUMBER: | |
| 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)

| (Division Sign-Off) | |
|----------------------------------------|---------|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K980677 |

Prescription Use_ (Per 21 CFR 801.109)

. "

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OR

Over-The-Counter Use X

(Optional Format 1-2-96)

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