RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)

K133193 · Riverstone Resources Sdn Bhd · LZA · Jun 23, 2014 · General Hospital

Device Facts

• Record ID: K133193
• Device Name: RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
• Applicant: Riverstone Resources Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jun 23, 2014
• 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 patients. Device performance meets ASTM D6319-10 standards for dimensions, physical properties, and freedom from pinholes. Biocompatibility confirmed via primary skin irritation and dermal sensitization assays. Provides protection during medical examinations.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D6319-10 standards for dimensions, physical properties, and freedom from pinholes. Biocompatibility testing conducted per ISO 10993-10:2010(E) (dermal sensitization) and CPSC Title 16, Part 1500 (primary skin irritation); results confirmed the device is a non-irritant and non-sensitizer.

Technological Characteristics

Material: Nitrile latex compound. Form factor: Disposable, powder-free, non-sterile glove. Standards: ASTM D6319-10 (dimensions, physical properties, pinholes). Biocompatibility: ISO 10993-10:2010(E) and CPSC Title 16, Part 1500. No electronic or software components.

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.

Predicate Devices

• RS Safe Blue Nitrile Medical Examination Gloves Powder Free (K100603)
• RS White Nitrile Examination glove Powder Free (K112928)

Submission Summary (Full Text)

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K133193

## JUN 2 3 2014

#### Appendix 2

#### 510(K) Summary Nitrile Examination Gloves Powder Free,Orange colour

#### 1.0 Submitter :

| Company Name | : Riverstone Resources Sdn.Bhd. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Company Address | : Lot 55&56,No.13&15 Jalaln Jasmin 2,<br>Kawasan Perindustrian Bukit Beruntung,<br>48300 Bukit Beruntung<br>Selangor,Malaysia. |
| Contact Person | : Mr Suresh Kumar |

Telephone No : 603-60283033

Email : qal @riverstone.com.my

#### 2.0 Preparation Date : 7th May 2014

#### 3.0 Name of the Device

Trade Name / Proprietary Name : RS Orange Nitrile Mcdical Examination Gloves ( Powder Free)

Device Name : Nitrile Paticnt 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 ) and K112928, RS White Nitrile Examination glove Powder Free (Non

Sterile) except for colour.

Section 2A-1

. . . . .

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#### Appendix 2

#### 5.0 Description of Device

Orange 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 nitrile from nitrile latex compound, orange 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 Device compared to the Predicate Device for substantial equivalent discussion

There is no different technology characteristics compared to the predicate device expect colour. Gloves are made from nitrile latex compound, Orange colour, powder free and non sterile. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) and K112928 ,RS White Nitrile Medical Examination Glove Powder Free (Non Sterile) except for colour.

Section 2A-2

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### Appendix 2

| Characteristics | RS Orange Nitrile<br>Medical Examination<br>Gloves<br>( Powder Free)<br>K133193 | RS Safe Blue Nitrile<br>Medical Examination<br>Gloves Powder Free<br>( Non-Sterile ) K 100603 | RS White Nitrile<br>Medical Examination<br>Gloves Powder Free<br>( Non-Sterile ) K 112928 |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | 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 on<br>the examiner's hand or<br>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 on<br>the examiner's hand or<br>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 on<br>the examiner's hand or<br>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 | Nitrile latex compound |
| Colour | Orange | Blue | White |
| Sterility | Non sterile | Non sterile | Non sterile |
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical properties | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from pinholes | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Powder -Free | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Biocompatability test-<br>Primary Skin Irritation Test | Under the conditions of<br>this study, the test article<br>was a non-irritant. | Under the conditions of<br>this study, the test article<br>was a non-irritant. | Under the conditions of<br>this study, the test article<br>was a non-irritant. |
| Dermal Sensitization<br>Assay | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. |

.

.

·

Section 2A-3

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#### Appendix 2

RS Orange Nitrile Medical Examination Gloves Powder Free posting the following technological characteristics

compared to ASTM or Equivalent standards:

| Characteristics | Standards | Device Performance<br>RS ORANGE Orange<br>Nitrile Medical<br>Examination Gloves<br>Powder Free<br>( Non-Sterile ) |
|----------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pinhole | 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 | Under the conditions of this<br>study, the test article was a<br>non-irritant |
| Biocompatability | Dermal Sensitization<br>Assay-<br>ISO 10993-10:2010(E) | Under the conditions of this<br>study, the test article was a<br>non-sensitizer. |

#### 8.0

#### Conclusion

It can be concluded that Orange 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. Performance testing data demonstrates , RS Orange Nitrile Medical Examination Glove (Powder Free) is substantially equivalent to the predicate devices (K100603 and K112928)

Section 2A-4

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Public Health Service

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

June 23, 2014

Riverstone Resources Sdn Bhd Mr. Suresh Kumar OA Manager Lot 55&56. No.13&15 Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung Selangor MALAYSIA 48300

Re: K133193

Trade/Device Name: RS Orange Nitrile Medical Examination Gloves (Powder Free) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA May 23, 2014 Dated: Received: May 27, 2014

Dear Mr. Kumar:

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 cnactment 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 docs 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. Kumar

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 of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

Tejashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K133193

Device Name

RS Orange Nitrile Medical Examination Gloves (Powder Free)

#### Indications for Use (Describe)

A 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Sreekanth Gutala

Digitally signed by Sreekanth Gutala -S

DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.06.20 12:39:56 -04'00'

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