POWDER FREE VINYL EXAMINATION GLOVE

K052985 · Tg Medical (China) Incorporation · LYZ · Jan 19, 2006 · General Hospital

Device Facts

• Record ID: K052985
• Device Name: POWDER FREE VINYL EXAMINATION GLOVE
• Applicant: Tg Medical (China) Incorporation
• Product Code: LYZ · General Hospital
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination Vinyl Powder Free Gľoves 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, powder-free vinyl examination glove. Used by healthcare professionals in clinical settings to provide a protective barrier between the examiner and the patient. Functions as a physical barrier to prevent cross-contamination. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Vinyl (polyvinyl chloride). Form factor: Disposable examination glove. Powder-free. Non-sterile. No electronic components or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner during medical examinations.

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

JAN 1 9 2006

Mr. Wu Kin Yeap General Manager TG Medical (China) Incorporated 3, Xitang Road, Xizhang Town Zhangjiagang, Jiangsu Province 215614 China

Re: K052985

Trade/Device Name: Powder Free Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 12, 2006 Reccived: January 17, 2006

Dear Mr. Yeap:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 cither class II (Special Controls) or class III (PMA), 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 8010 161598. In addition, FDA may publish further announcements concerning your device in the Foresal Register.

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Page 2 - Mr. Yeap

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other on quirements of the Act or any Federal statutes and regulations administered by other Federal reqencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the 1,c1); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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, purmits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly vours.

Snea y. Michael Davis

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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## Indications for Use

510(k) Number (if known): K052985

Device Name: Powder Free Vinyl Examination Glove

Indications For Use:

A patient examination Vinyl Powder Free Gľoves is a disposable A pattent examination viny in the is worn on the examiner' device Intended for medical patient and examiner.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula M. Murphy, MD 1/19/06

Radiology, General Hospital,
Control, Dental Devices

K052985

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