MULTIPLE PRIVATE LABEL

K100162 · Biogreen Yields Sdn.Bhd · LZA · Mar 24, 2010 · General Hospital

Device Facts

• Record ID: K100162
• Device Name: MULTIPLE PRIVATE LABEL
• Applicant: Biogreen Yields Sdn.Bhd
• Product Code: LZA · General Hospital
• Decision Date: Mar 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.

Device Story

Non-sterile, blue, powder-free nitrile examination glove; disposable; worn by healthcare examiners or individuals in over-the-counter settings. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Performance verified against ASTM D6319-05 standards for watertight integrity, dimensions, physical properties (tensile strength/elongation), and powder residue limits. Biocompatibility confirmed via primary dermal irritation and guinea pig sensitization testing.

Clinical Evidence

Bench testing only. Performance data includes FDA 1000ml water leak test (AQL 2.5), physical dimensions, tensile strength (22-32 MPa before aging), ultimate elongation (710-750% before aging), powder content (<2 mg/glove), and moisture content (0.57%). Biocompatibility testing included primary dermal irritation and Guinea Pig Sensitization (Buehler) test.

Technological Characteristics

Material: Nitrile rubber. Form: Powder-free, blue, disposable examination glove. Standards: ASTM D6319-05. Physical properties: Tensile strength >14 MPa (before/after aging), elongation >500% (before aging) and >400% (after aging). Thickness: 0.08-0.09mm (finger), 0.06-0.07mm (palm).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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.

Reference Devices

• ASTM D6319-05 Standard Specification for Nitrile Examination Gloves for Medical Application

Submission Summary (Full Text)

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Ki0016.2

BIOGREEN YIELDS SDN. BHD. Lot 1422, Batu 10 Lekir 32020 SITIAWAN, PERAK, MALAYSIA

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MAR 2 4 2010

# 510(k) SUMMARY

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BIOGREEN YIELDS SON. BHD. LOT 1422, BATU 10 LEKIR 32020 SITIAWAN, PERAK, MALAYSIA

| 510 (K) SUMMARY SHEETS |
|------------------------|
|------------------------|

| 1.0 | |
|-----|--|
|-----|--|

| | SMDA 510 (K) SUMMARY |
|--------------------------|----------------------------------------------------------------------------------------------|
| 2.0 Submitter | BIOGREEN YIELDS SDN. BHD.,<br>Lot 1422, Batu 10 Lekir<br>• 32020 Sitiawan, Perak<br>Malaysia |
| Tel | 605-6792288 |
| Fax | 605-6791188 |
| Name of Contact Person | 1. Mr. Tiong Chiong Kieng<br>2. Mr. Arivalagan |
| Date of Summary Prepared | January 5, 2010 |

#### 3.0 Name of Device

Trade Name: Non-Sterile, Blue Color Powder Free Nitrile Examination Glove

Common Name: Synthetic Rubber Examination Gloves

Classification Name: Patient Examination Glove, Powder Free

### 4.0 Identification of The Legally Marketed Devices

Non Sterile Powder Free Nitrile Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product Specification DC310 06, School Specifications listed under the prove Specification D6319-05, Standard Specification for Nitrile Gloves for Medical Application.

#### 5.0 Description of The Device

Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.

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## BIOGREEN YIELDS SDN. BHD. Lot 1422, Batu 10 Lekir

32020 SITIAWAN, PERAK, MALAYSIA

### 6.0 The Intended Use of Glove

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.

### 7.0 Summary of Performance Data:

Performance data of gloves based on ASTM D6319-05 and FDA 1000ML watertight test.

| Test | FDA 1000ml Water Leak<br>Test | Powder Free Nitrile Examination<br>Gloves |
|-------------------------------------------------------------------|-------------------------------|-------------------------------------------|
| | Multiple Normal | |
| 1. Watertight (1000ml) | GI<br>AQL = 2.5 | Pass |
| Test | ASTM D6319-05 | |
| 2. Length (mm)<br>Size<br>M<br>L<br>XL | Min 230<br>Min 230 | 240 - 248 |
| 3. Palm width (mm)<br>Size<br>M | 95 ± 10 | 95 - 98 |
| 4. Thickness (mm)<br>(Single Layer) | | |
| Finger<br>Palm | Min 0.05<br>Min 0.05 | 0.08 - 0.09<br>0.06 - 0.07 |
| 5. Physical Properties | | |
| Before Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 500 | 22 - 32<br>710 - 750 |
| After Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 400 | 22 - 29<br>630 - 690 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| 7. Moisture Content | Max 2.0% | 0.57% |

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### BIOGREEN YTELDS SDN. BHD. LOT 1422, BATU 10 LEKIR 32020 SITIAWAN, PERAK, MALAYSIA

- 8.0 The performance data of the glove as shown above meet the ASTM D6319-05 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- 9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion

We conclude that the Non-Sterile, Blue Color Powder Free Nitrile Examination Gloves meets:

- . ASTM D6319-05 Standard
- . FDA pinhole requirements
- Are below the maximum Powder Residual Content as specified in ASTM D6319-05

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Image /page/4/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, rendered in blue. The overall design is clean and professional, representing the department's role in public health and welfare.

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

MAY 20 2010

Mr. Tiong Chiong Kieng Director Biogreen Yields Sdn. Bhd Lot 1422 Batu 10 Lekir Sitiawan Perak MALAYSIA 32020

Re: K100162

Trade/Device Name: Non Sterile, Blue Color Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 5, 2010 Received: January 20, 2010

Dear Mr. Kieng:

This letter corrects our substantially equivalent letter of March 24, 2010 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 (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.

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. Kieng

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 yours,

Susan Rusner

Anthony 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

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K100162

### Indications for Use

510(k) Number (if known): K100162

Device Name: Non Sterile, Blue Color Powder Free Nitrile Examination Gloves

Indications For Use:

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

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

Over-The-Counter Use _ 1 (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

510(k) Number: _ |< | 0 0 | 6 2