RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME

K112928 · Riverstone Resources Sdn Bhd · LZA · Apr 17, 2012 · General Hospital

Device Facts

• Record ID: K112928
• Device Name: RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
• Applicant: Riverstone Resources Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Apr 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free 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. It is for over-the-counter use.

Device Story

Disposable, non-sterile, powder-free patient examination glove; manufactured from nitrile latex compound. Worn on examiner's hand or finger; acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical or home settings by healthcare providers or lay users. Device provides protection during medical examinations. No complex processing or electronic components.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D6319-10 standards for dimensions, physical properties, and freedom from pinholes. Biocompatibility confirmed via Primary Skin Irritation Test (Consumer Product Safety Commission, Title 16, Part 1500) and Dermal Sensitization Assay (ISO 10993-10:2010).

Technological Characteristics

Material: Nitrile latex compound. Form factor: Disposable, powder-free, non-sterile glove. Standards: Meets ASTM D6319-10 for dimensions, physical properties, and freedom from pinholes. Biocompatibility: Complies with ISO 10993-10:2010 and CPSC Title 16 Part 1500.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Intended for over-the-counter use.

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.

Predicate Devices

• RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) (K100603)

Submission Summary (Full Text)

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#### Appendix 2

## 510(k) Summary Nitrile Examination Gloves Powder Free, White colour

1.0 Submitter:

K11292.8

Company Name: Riverstone Resources Sdn. Bhd.

Company Address: Lot 55& 56, No. 13&15 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia.

Contact Person: Ms Chong Chu Mee

Telephone No: [phone]

Fax No: + 603-60283022

2.0 Preparation Date: 5th Jan 2012

#### 3.0 Name of the Device

Trade Name/ Proprietary Name: RS WHITE Nitrile Medical Examination Gloves (Powder Free)

Device Name: Nitrile Patient Examination gloves

Device Classification Name: Patient Examination gloves (21 CFR 880.6250)

Device Class: Class I

Product Code : Nitrile - LZA

#### 4.0 Identification of The Legally Marketed Device:

Class I patient Examination gloves, Powder Free, LZA which meets all the

requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.

It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves

Powder Free (Non-Sterile) except for colour.

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#### 5.0 Description of Device

White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, white colour, powder free and non sterile.

#### 6.0 Intended use of the Device

A powder-free 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. It is for over-the-counter use.

# 7.0 Summary of the Technological Characteristics of the Devices compared to the Predicate Device for substantial equivalent discussion

There is no different technology characteristics compared to the predicate device except colour. Gloves are made from nitrile latex compound, White colour, powder free and non sterile. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) except for colour.

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| Characteristics | RS WHITE Nitrile<br>Medical Examination<br>Gloves (Powder Free) | RS Safe Blue Nitrile<br>Medical Examination<br>Gloves Powder Free<br>(Non-Sterile) K 100603 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA |
| Intended use | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use. | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use. |
| Material use | Nitrile latex compound | Nitrile latex compound |
| Colour | White | Blue |
| Sterility | Non sterile | Non sterile |
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Physical properties | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Freedom from pinholes | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Powder-Free | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Biocompatability test -<br>Primary Skin Irritation<br>Test | Passes | Passes |
| Dermal Sensitization | Passes | Passes |
| Assay | | |
| Characteristics | Standards | Device Performance |
| | | RS WHITE Nitrile Medical |
| | | Examination Gloves |
| | | Powder Free (Non-Sterile) |
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pinholes | ASTM D 6319-10 | Meets |
| Powder-Free | ASTM D 6319-10 | Meets |
| Biocompatability | Primary Skin Irritation Test<br>Consumer Product Safety<br>Commission, Title 16,<br>Chapter II, Part 1500<br>Dermal Sensitization<br>Assay<br>- ISO 10993-10:2010(E) | Passes |

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RS WHITE Nitrile Medical Examination Gloves Powder Free possesses the following technological characteristics compared to ASTM or Equivalent standards:

## 8.0 Conclusion

It can be concluded that White Nitrile Medical Examination Gloves (Powder Free) will perform according to the glove performance standards ASTM D 6319-10, biocompatibility requirement and FDA requirements and the labeling claims for the product.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

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

Ms. Chong Chu Mee Technical Manager River Stone Resources Sdn. Bhd. Lot 55 & 56, NO. 13 & 15, Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia

· Re: K112928

Trade/Device Name: RS WHITE Nitrile Medical Examination Gloves (Powder Free)

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove

Regulatory Class: I

Product Code: LZA Dated: March 30, 2012 Received: April 4, 2012

Dear Ms. Chu Mee:

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.

APR 1 7 2012

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#### Page 2 - Ms. Chu Mee

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/ReportaProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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G. Anthony D. Watson, B.S., M.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

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Appendix 1

# INDICATION FOR USE

Riverstone Resources Sdn. Bhd.

510(K) Number: K112928

Device Name:

Applicant:

## RS WHITE Nitrile Medical Examination Gloves

## (Powder Free)

A powder-free 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.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Dokie faugulis

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

510(k) Number: K112928

Section 1A-1