← Product Code [LZA](/productcode/LZA) · K083717

# POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK (K083717)

_Gx Corporation Sdn Bhd · LZA · Jan 30, 2009 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K083717

## Device Facts

- **Applicant:** Gx Corporation Sdn Bhd
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jan 30, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

## Device Story

Powder-free nitrile examination glove; bubble gum scented; pink color. Disposable device; worn on examiner's hand. Primary function: barrier protection to prevent cross-contamination between patient and examiner during medical examinations. Used in clinical settings by healthcare professionals. Simple physical barrier; no electronic or software components.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Nitrile material; powder-free; bubble gum scented; pink color. Disposable form factor. Class I medical device.

## 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)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

## Public Health Service

JAN 9.0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Foo Khon Pu GX Corporation Sdn. Bhd. Lot 6487A, Batu 5 3/4, Samenta, Off Jalan Kapar 42100 Kang, Selangor Darul Ehsan MALAYSIA

Re: K083717

> Trade/Device Name: Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Pink Regulation Number: 880.6250 Regulation Name: Patient Examination Glove

Regulatory Class: I Product Code: LZA

Dated: December 12, 2008

Received: December 15, 2008

Dear Mr. Pu:

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 Federal Register.

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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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Antron V.m

Civil Judicial MD

Ginette Y. Michaud, M.D 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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## Indications for Use

K 08:3717 510(k) Number (if known):

Device Name:

Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Pink

Indication For Use:

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Prescription Use J (Part 21 CFR 801 Subpart D)

AND/OR

X 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)

Shalie Murphy, RO
(Division Sign-Off)

Division of Anesthestology, General Hospital Infection Control, Dental Devices

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510(k) Number:

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**Source:** [https://fda-staging.innolitics.com/device/K083717](https://fda-staging.innolitics.com/device/K083717)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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