← Product Code [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ) · K043499

# POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043499)

_Shijaizhuang Brilliant Ocean Plastic Co., Ltd. · LYZ · Feb 4, 2005 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K043499

## Device Facts

- **Applicant:** Shijaizhuang Brilliant Ocean Plastic Co., Ltd.
- **Product Code:** [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ.md)
- **Decision Date:** Feb 4, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

## Device Story

Powder-free yellow synthetic vinyl patient examination glove; disposable; worn on examiner's hand. Used in clinical or medical settings to provide a barrier against contamination between patient and examiner. Protects both parties during examinations.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Synthetic vinyl material; powder-free; disposable; patient examination glove.

## Regulatory 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2005

Shijiazhuang Brilliant Ocean Plastic Company Limited C/O Ms. Emmy Tjoeng Official Correspondent Shamrock Manufacturing Company, Incorporated 5445 Daniels Street Chino, California 91710

Re: K043499

Trade/Device Name: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 10, 2005 Received: January 14, 2005

Dear Ms. Tjoeng:

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 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 Eederal Register.

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## Page 2 - Ms. Tjoeng

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 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, permits 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 (240) 276-0115. 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

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: Shijiazhuang Brilliant Ocean Plastic Co.Ltd.

510(k) Number (if known): _ K043499

Device Name: _Powder Free Yellow Synthetic Vinyl Patient Examination Gloves

Indications For Use:

A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

______________________________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use X (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)

Soyute Michiu c

- Maris Bon-C reson of Anesthesiology, General Hospital, in: sotion Control, Dental Devices

Number: K 043 499

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K043499](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K043499)

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