PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES

K042213 · Shandong Perfect Plastic Co., Ltd. · LYZ · Sep 9, 2004 · General Hospital

Device Facts

• Record ID: K042213
• Device Name: PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
• Applicant: Shandong Perfect Plastic Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A pre-powdered patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

Device Story

Pre-powdered vinyl non-sterile examination glove; disposable; worn on examiner's hand or fingers. Functions as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical or medical settings by healthcare professionals. Device provides protection during patient examinations.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Vinyl material; non-sterile; pre-powdered; disposable; Class I patient examination glove (21 CFR 880.6250).

Indications for Use

Indicated for use as a disposable patient examination glove worn by healthcare personnel 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

SEP - 9 2004

Shandong Perfect Plastic Company Limited C/O Mr. Alan P. Schwartz Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K042213

Trade/Device Name: Pre- Powdered Vinyl Non-Sterile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 13, 2004 Received: August 16, 2004

Dear Mr. Schwartz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 vir device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of router announcements concerning your device in the Federal Register.

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Page 2 - Mr. Schwartz

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that I Dr. o to termination that your device complies with other requirements modi that 1 Dr. I has made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal baracter and sequirements, including, but not limited to: registration 1 od intist comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 es rear of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet rests nroduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow Jourse boga finding of substantial equivalence of your device to a premaired 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 regulation (21 CFR Part 801), If you dosite specific at Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

CARS

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SHANDONG PERFECT PLASTIC CO., LTD. NO.3 SUNSHINE RD. WULIAN COUNTY, SHANDONG PROVINCE, CHINA

TEL: [phone] FAX: [phone]

## EXHIBIT B

## INDICATIONS FOR USE

ShanDong Perfect Plastic Products Co., Ltd. Applicant's Name:

Device Name:

Pre-Powdered Vinyl Non-sterile Examination Glove

Indications For Use:

A pre-powdered patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mully

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042213