RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)

K100603 · Riverstone Resources Sdn Bhd · LZA · Jul 16, 2010 · General Hospital

Device Facts

• Record ID: K100603
• Device Name: RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
• Applicant: Riverstone Resources Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jul 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Examination gloves powder free blue colour 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. The device is for overthe-counter use.

Device Story

Disposable nitrile examination glove; blue color; powder-free. Worn on examiner's hand or finger; prevents contamination between patient and examiner. Used in medical settings; available for over-the-counter use. Provides barrier protection to reduce risk of cross-contamination.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D6319-00a for dimensions, physical properties, and freedom from pinholes. Biocompatibility confirmed via Primary Skin Irritation Test (CPSC Title 16, Part 1500) and Dermal Sensitization Assay (ASTM F720-81).

Technological Characteristics

Material: Nitrile latex compound. Form: Powder-free, blue, non-sterile. Standards: ASTM D6319-00a (dimensions, physical properties, pinholes). Biocompatibility: CPSC Title 16 Part 1500 (skin irritation), ASTM F720-81 (dermal sensitization).

Indications for Use

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

Submission Summary (Full Text)

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K100603

Appendix 2

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

1.0 Submitter:

JUL 1 3 2010

Company Name: Riverstone Resources Sdn. Bhd.

Company Address: Lot 56, No. 13 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 Name of the Device
Trade Name/ Proprietary Name: RS Safe Blue 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

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

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

requirement of ASTM D 6319-00a and FDA 21 CFR 880.6250.

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#### 4.0 Description of Device

Nitrile Examination gloves powder free blue colour 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 D6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, blue colour and powder free.

### 5.0 Intended use of the Device

Nitrile Examination gloves powder free blue colour 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. The device is for overthe-counter use.

#### 6.0 Summary of the Technological Characteristics of the Devices

The powder-free nitrile examination gloves blue colour possess the following technological characteristics compared to ASTM or Equivalent standards:

| Characteristics | Standards | Device Performance |
|-----------------------|-----------------------------------------------------------------------------------------------------------|--------------------|
| Dimension | ASTM D 6319-00a | Meets |
| Physical Properties | ASTM D 6319-00a | Meets |
| Freedom from pinholes | ASTM D 6319-00a | Meets |
| Powder-Free | ASTM D 6319-00a | Meets |
| Biocompatibility | Primary Skin Irritation Test<br>Consumer Product Safety<br>Commission, Title 16,<br>Chapter II, Part 1500 | Passes |
| | Dermal Sensitization Assay<br>ASTM-F 720-<br>81(Reapproved 2007)El | Passes |

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# 7.0 Conclusion

It can be concluded that nitrile examination gloves powder free blue colour will perform according to the glove performance standards ASTM D 6319-00a, biocompatibility requirement and FDA requirements and the labeling claims for the product.

Prepared By,

Chath

Chong Chu Mee Technical Manager Date: 22th Feb 2010

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus symbol, representing health and medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.

#### Public Health Service

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

# JUL 1 6 2010

Mr. Chong Chu Mee Technical Manager Riverstone Resources SDN. BHD. Jalan Jasmin 2, 48300 Bukit Beruntung Selangor. Malaysia 48300

Re: K100603

Trade/Device Name: RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 12, 2010 Received: April 30, 2010

Dear Mr. 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.

. ::

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Page 2- Mr. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours,

hin for

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

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# INDICATION FOR USE

| Applicant: | Riverstone Resources Sdn. Bhd. |
|----------------|-------------------------------------------------|
| 510(K) Number: | K 100603 |
| Device Name: | RS Safe Blue Nitrile Medical Examination Gloves |
| | Powder Free (Non-Sterile) |

A powder-free patient examination gloves 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 . X Frescription Ose _____________________________________________________________________________________________________________________________________________________________ (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)

:

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

510(k) Number: __ KL00603