POWDER FREE VINYL EXAMINATION GLOVES

K983856 · Shijiazhuang Brethern Plastic Co., Ltd. · LYZ · Jun 21, 1999 · General Hospital

Device Facts

• Record ID: K983856
• Device Name: POWDER FREE VINYL EXAMINATION GLOVES
• Applicant: Shijiazhuang Brethern Plastic Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Story

Powder-free vinyl examination gloves; intended as a protective barrier for healthcare personnel; worn on hands to prevent cross-contamination between patient and clinician; disposable; non-sterile; used in clinical or similar settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Vinyl (polyvinyl chloride). Form factor: Disposable examination glove. Feature: Powder-free. Sterilization: Not specified.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the wearer and the patient.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 1999

Mr. Xin-Lai Zhou General Manager Shijiazhuang Brethren Plastic Company, Limited No. 37 Zhonghua South Street Shijiazhuang, Hebei CHINA

Re : K983856 Powder Free Vinyl Examination Gloves Trade Name: Regulatory Class: I Product Code: LYZ May 20, 1999 Dated: Received: May 24, 1999

Dear Mr. Xin-Lai Zhou:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Xin-Lai Zhou

this response to your premarket notification Please note: ricable note: chirt any obligation you might have under sections 531 through 542 of the Act for devices under the Bectronic 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 acberroom in four for 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
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,

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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石家庄博森塑料制品有限公司 SHIJIAZHUANG BRETHREN PLASTIC CO., LTD. n: 205 ?HQNGHUA SOUTH SI SHIJIAZHUANG HEBEI.CHINA IFI 86-311-7021447 · 4. 96-311-7024360 · · · · · · Attachment I

INDICATION FOR USE STATEMENT

510(K) Number(if known): and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi

Powder Free Vinyl Examination Gloves Device Name:

Indication For Use:

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Truthfully Yours,

General Manager

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

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| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K983856 |

| Prescription Use | OR Over-The-Counter Use X |
|------------------|---------------------------|
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(Optional Format 1-2-96)