RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)

K100611 · Riverstone Resources Sdn Bhd · LYY · Jul 16, 2010 · General Hospital

Device Facts

• Record ID: K100611
• Device Name: RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
• Applicant: Riverstone Resources Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jul 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Latex Examination gloves powder free is a disposable device intended for medical purpose is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

Device Story

Disposable natural latex examination gloves; 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 physical barrier protection.

Clinical Evidence

Bench testing only. Device performance verified against ASTM D 3578-05 standards for dimensions, physical properties, pinhole freedom, powder-free status, and protein content. Biocompatibility confirmed via Primary Skin Irritation Test and Dermal Sensitization Assay (ASTM-F 720-81).

Technological Characteristics

Natural latex compound; powder-free. Dimensions, physical properties, and protein content meet ASTM D 3578-05. Biocompatibility per 16 CFR Part 1500 and ASTM-F 720-81. Non-sterile.

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.

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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Kro06.11

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Appendix 2

# 510(k) Summary Latex Examination Gloves Powder Free

JUL 1 62010

#### 1.0 Submitter:

Company Name: Riverstone Resources Sdn. Bhd.

Company Address: Lot 55, 56, No. 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 Name of the Device
Trade Name/ Proprietary Name: RS Care Latex Examination Gloves Powder Free

Device Name: Latex Patient Examination gloves

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

Device Class: Class I

Product Code : Latex - LYY

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

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

requirement of ASTM D 3578-05 and FDA 21 CFR 880.6250.

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## 4.0 Description of Device

Latex Examination gloves powder free as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LYY (21CFR 880.6250). It meets all the specifications in ASTM D 3578-05, Standard Specification for Latex Examination Gloves. They are made from natural latex compound and powder free.

## 5.0 Intended use of the Device

Latex Examination gloves powder free is a disposable device intended for medical purpose is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

# 6.0 Summary of the Technological Characteristics of the Devices

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

| Characteristics | Standards | Device Performance |
|-----------------------|-----------------------------------------------------------------------------------------------------------|--------------------|
| Dimension | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from pinholes | ASTM D 3578-05 | Meets |
| Powder-Free | ASTM D 3578-05 | Meets |
| Protein Content | ASTM D 3578-05 | Meets |
| Biocompatibility | Primary Skin Irritation Test<br>Consumer Product Safety<br>Commission, Title 16, Chapter<br>II, Part 1500 | Passes |
| | Dermal Sensitization Assay<br>ASTM-F 720-81(Reapproved<br>2007)EI | Passes |

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## 7.0 Conclusion

It can be concluded that latex examination gloves powder free shall perform according to the glove performance standards references in section 6.0 above and meet ASTM D 3578-05 standard and FDA requirements and the labeling claims for the product.

Prepared by,

---

Chong Chu Mee Technical Manager Date: 22th Feb 2010.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

JUL 1 62010

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

Mr. Chong Chu Mee Technical Manager Riverstone Resources SDN. BHD. Lot 55 & 56, Number 15, Jalan Jasmin 2 Kawasan Perindustrian Bukit 48300 Bukit Beruntung Selangor, Malaysia

Re: K100611

Trade/Device Name: RS Care Latex Medical Examination Gloves Powder Free (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 12, 2010 Received: June 22, 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: CDDH, 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 First 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/CentersQffices/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,

Nh 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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# INDICATIONS FOR USE

Applicant: Riverstone Resources Sdn. Bhd. 510(k) Number (if known): K100611

Device Name: RS Care Latex Medical Examination Gloves Powder Free (Non-Sterile)

## Indications for Use:

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 Prescription 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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: __ K 1006 l/

Section 1A-1