POLY (VINYL) EXAM GLOVE, POWDERED

K971316 · Copioumed Intl., Inc. · LYZ · Aug 27, 1997 · General Hospital

Device Facts

• Record ID: K971316
• Device Name: POLY (VINYL) EXAM GLOVE, POWDERED
• Applicant: Copioumed Intl., Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Aug 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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

Patient examination glove; disposable; poly(vinyl) material; powdered. Worn on examiner's hand or finger during medical examinations. Primary function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Simple physical barrier device; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Poly(vinyl) (PVC); powdered. Form factor: Disposable glove. Energy source: None. Connectivity: None. Sterilization: Not specified.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Copioumed International, Incorporated
C/O Ms. Janna P. Tucker
President
Janna Tucker and Associates
19001 South Richfield # 185
Green Valley, Arizona 85614

FEB 7 2008

Re: K971316
Trade/Device Name: Patient Examination Glove, Poly (Vinyl) Powered Regulatory Class: I
Product Code: LYZ
Dated: June 13, 1997
Received: June 16, 1997

Dear Ms. Tucker:

This letter corrects our substantially equivalent letter of August 27, 1997.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Tucker

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 requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 practice 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 Act); 21 CFR 1000-1050.

This letter will allow you to continue 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, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,


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

Applicant: COPIOUMED INTERNATIONAL, INC.
10(k) Number (if known):

Device Name:

Indications For Use: PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDERED

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)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number: K971316

Stipition Use
21 CFR 801.109

OR

Over-The-Counter ☑
(Optional Format 1-2-96)

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