← Product Code [LZA](/productcode/LZA) · K110960

# ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE (K110960)

_Koon Seng Sdn Bhd · LZA · Jul 14, 2011 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K110960

## Device Facts

- **Applicant:** Koon Seng Sdn Bhd
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jul 14, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## Device Story

Single-use disposable nitrile examination glove; textured surface; powder-free; blue color. Worn on examiner's hand or finger during medical examinations. Acts as physical barrier to prevent contamination between patient and examiner. Used in clinical settings. No complex electronics or software.

## Clinical Evidence

Bench testing only. Compliance demonstrated with ASTM D3578-05, ASTM D6124-06, ASTM D6319-10, and ISO 10993-10.

## Technological Characteristics

Nitrile material; textured surface; powder-free; blue. Meets ASTM D6319-10 specifications. Single-use, non-sterile.

## 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.

## Predicate Devices

- Ultrawin SDN BHD Non-Sterile, Powder Free Nitrile Examination Gloves ([K090828](/device/K090828.md))

## 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.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/).

{0}------------------------------------------------

# K110960

JUL 1 4 2011

# Royal Imperial Nitrile Examination Gloves -Textured. Powder-Free Blue. 510(k). Summary__________________________________________________________________________________________________________________________________

Date prepared: June 3, 2011

#### Name and Address of Sponsor

Koon Seng SDN. BHD. 16058, Kaw. Perindustrian Tangkak, 84900 Tangkak, Johor, Malaysia Ph: 606-979 1778 Fax: 606-979 1779 Email: koonsen@po.jaring.my

#### Name and Address of Official Correspondent

Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, Colorado 80121 Contact: Mr. Kevin Walls, RAC Tel: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com

#### Device Name

Trade Name: Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue Common Name: Patient examination glove Classification Name: Polymer patient examination glove

# Classification, Panel and Product Code

Class 1. General Hospital, LZA

#### Substantial Equivalence

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue are substantially equivalent to the Ultrawin SDN BHD Non-Sterile, Powder Free Nitrile Examination Gloves (K090828).

#### Device Description

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a class I medical device classified under Product Code LZA. It is a single-use disposable device that meets all requirements of ASTM D 6319-10.

{1}------------------------------------------------

KII0960

#### Indications for Use

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a singleuse disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

#### Intended Use

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

# Summary of Non-clinical Testing Data

The Roval Imperial Nitrile Examination Gloves Textured Powder-Free Blue was tested in accordance, and found to be in compliance, with ASTM D3578-05, ASTM D6124-06, ASTM D6319-10 and ISO 10993-10. The test reports and the Forms FDA 3654 may be found in the body of the 510(k) premarket notification.

#### Conclusion Statement

Based on the fact that the Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue passed all the tests associated with the FDA-recognized consensus standards listed above, the Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue are substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Koon Seng SDN. BHD. C/O Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Incorporated 5401 South Cottonwood Court Greenwood Village, Colorado 80121

JUL 1 4 2011

Re: K110960

Trade/Device Name: Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 3, 2011 Received: June 7, 2011

# Dear Mr. Walls:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{3}------------------------------------------------

Page 2 - Mr. Walls

:

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/MedicalDevices/Safety/Repo rtaProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D, Owen

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Indications for Use

# 510(k) Number (if known): K110960

Device Name: Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue

Indications for Use: The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a single-use disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronie Rangsuluri

·Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K110960

Page 1 of 1

---

**Source:** [https://fda-staging.innolitics.com/device/K110960](https://fda-staging.innolitics.com/device/K110960)

**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).

**Cite:** Innolitics at https://innolitics.com