PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED

K992100 · Shanghai Palomar Mountain Industries, Inc. · LYZ · Jul 29, 1999 · General Hospital

Device Facts

• Record ID: K992100
• Device Name: PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED
• Applicant: Shanghai Palomar Mountain Industries, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Story

PVC synthetic examination gloves; disposable; powdered. Worn by healthcare examiners on hands or fingers. Function: physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. Benefit: infection control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Polyvinyl Chloride (PVC). Form factor: Disposable, powdered examination glove. Class I device.

Indications for Use

Indicated for use as a disposable medical 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

JUL 29 1999

Mr. Danny Wang Manager Shanghai Palomar Mountain Industries, Incorporated No. I, Biyu Road, Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.

Re : K992100 PVC (Polyvinyl Chloride) Synthetic Trade Name: Examination Gloves, Powdered Regulatory Class: I Product Code: LYZ April 26, 1999 Dated: Received: June 21, 1999

Dear Mr. Wang:

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 reqistration, 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) 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Wang

this response to your premarket notification Please note: 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.

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 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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- 3.0 Indications for Use.Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
## INDICATIONS FOR USE INDICATIONSTONSTON PALOMAR MOUNTAIN INDUSTRIES, INC. 992100 510(k) Number (if known): * PVC SYNTHETIC EXAMINATION GLOVES, POWDERED Device Name: DISPOSABLE Indications For Use: INATION GLOVE IS A DISPOSABLE DEVICE A PATIENT

INTENDED FOR MEDICAL PURPOSES 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 Per 21 CFR 801.109

Over-The-Counter X

(Optional Format 1-2-96)

For a new submission, do NOT fill in the 510(k) number blank.

Qais. Lim

(Division Sign-Off) wision of Dental, Infection t