POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES

K983612 · Shanghai Jiatai Plastic Products Co., Ltd. · LYZ · Nov 5, 1998 · General Hospital

Device Facts

• Record ID: K983612
• Device Name: POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
• Applicant: Shanghai Jiatai Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 5, 1998
• 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 purpooses that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Device is a powder-free, non-sterile vinyl patient examination glove. Used by healthcare professionals to provide a barrier against contamination between the examiner and the patient. Disposable, single-use design. Intended for general clinical examination settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Vinyl (synthetic). Form factor: Disposable, powder-free, non-sterile examination glove. Class I medical device.

Indications for Use

Indicated for use as a disposable patient examination glove 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1998 NOV

Shanghai Jiatai Plastic Products company, Limited C/O Mr. Don Morris U.S. Contact 30798 US Highway, 19N Palm Harbor, Florida 34684 U.S.A.

K983612 Re : Powder-Free Non-sterile Vinyl Examiantion Trade Name: Gloves Requlatory Class: I Product Code: LYZ September 29, 1998 Dated: Received: October 14, 1998

Dear Mr. Morris:

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 reqistration, listing of devices, qood 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. ਰ 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 requlation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Morris

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 diaqnostic 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,

Susa, Ronne

O 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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Page 1 _of

K983612 510(k) NUMBER (IF KNOWN):

DEVICE NAME: Jiatai Synthetic Vinyl Exam_Gloves, Powder-Free INDICATIONS FOR USE:

A patient examination glove is a disposable device intended for medical purpooses 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 **__** OR Over-The-Counter-Use X
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983612