PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES

K983613 · Shanghai Jiatai Plastic Products Co., Ltd. · LYZ · Oct 27, 1999 · General Hospital

Device Facts

• Record ID: K983613
• Device Name: PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
• Applicant: Shanghai Jiatai Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for 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

Device is a disposable, pre-powdered, non-sterile vinyl examination glove. Used by healthcare professionals or individuals in clinical or home settings to provide a protective barrier on the hand or finger. Acts as a physical barrier to prevent cross-contamination between the examiner and the patient during medical examinations or procedures. Device is intended for single use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Vinyl. Form factor: Disposable, pre-powdered examination glove. Non-sterile. Class I device.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1999

Shanghai Jiatai Plastic Products Company, Limited c/o Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, NY 89434-9550

Re : K983613

> Trade Name: Pre-Powdered Non-Sterile Vinyl Examination Gloves Requlatory Class: I Product Code: LYZ Dated: October 4, 1999 Received: October 8, 1999

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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Eederal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Tucker

obligation you might have under sections 531 through 542 of obligation you might have ahe Electronic Product Radiation the Act for devices ander enderal laws or regulations.

This letter will allow you to begin marketing your device as Info Iceeer will areas) premarket notification. The FDA described in your sisting prour device of your device to a legally marketed predicate device results in a classification for your marketed predicate device rusales in the to proceed to the market.

If you desire specific advice for your device on our labeling II you debite operile additionally 809.10 for in regulation (21 ellevices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compilance at [phone]. Fishing of your device, please contact the promocion and advercibing or just 1639. Also, please note the office of Compriance at (30anding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsibiliation of Small Manufacturers Assistance obtained Trom the Division of Bilard (300) 443-659) or at at its coll free namber (0)//www.fdaygov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Ulatowski Directør Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1983613 510(k) NUMBER (IF KNOWN) :

DEVICE NAME: Jiatai Synthetic Vinyl Exam Gloves, Powdered, USP

INDICATIONS FOR 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

Clim S. lir

(Civision Sign-Off) Proision of Dental, Infection Control, and General Hospital D 51000) Number