NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)

K091422 · Novapro Co., Ltd. · LYZ · Jul 30, 2009 · General Hospital

Device Facts

• Record ID: K091422
• Device Name: NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
• Applicant: Novapro Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Stretch Vinyl examination glove(Yellow/white) 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

Disposable stretch vinyl examination gloves; worn on examiner's hand or finger; intended to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical settings by healthcare professionals. Device acts as a physical barrier.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stretch vinyl material; disposable; non-sterile; powder-free; yellow/white color; form-fitting glove design.

Indications for Use

Indicated for use as a disposable medical device 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Zhenzhong Cheng Factory Manager Novapro Company, Limited No. 21 Qingtian Road, Lot 4 Zibo, Shandong China 255414

JUL 3 0 2009

Re: K091422

Trade/Device Name: Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White Regulation Number: 21 CFR 880.6250 · Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 8, 2009 Received: May13, 2009

Dear Mr. Cheng:

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 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- Mr. Cheng

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Amen in bu
S. Rev. R.R.S.M.

Susan Runner, D.D.S., M.A. Acting 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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Novapro Co., Ltd.

## Appendix 3

## (PREMARKET NOTIFICATION - INDICATION FOR USE)

(as required by 21 CFR 801.109)

510(k) Number (if known): _

Device Name: Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White

A Stretch Vinyl examination glove(Yellow/white) is a disposable device intended for medical A Stretch Vinyl examination glove(Yellowwhile) is a disposuals as a seem patient
purposes that is worn on the examiner's hand or finger to prevent contamination between patie and examiner.

Yours faithfully,

Shule H. Murphy, MD

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

510(k) Number: K091422

Prescription Use (Part 21 CFR 801 Subpart D) 13322

Zhenzhong Cheng Factory Manager April 2nd, 2009

Over-The-Counter Use _ X AND/OR (21 CFR 801 Subpart )

(Please do not write below this line-continue on another page of NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)