NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE

K031580 · Green Prospect Sdn Bhd · LZA · Jul 25, 2003 · General Hospital

Device Facts

• Record ID: K031580
• Device Name: NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
• Applicant: Green Prospect Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jul 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Non-sterile, powder-free, blue nitrile examination glove; worn by healthcare personnel to provide a protective barrier against body fluids, waste, and environmental contaminants. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical settings to prevent cross-contamination between patients and healthcare workers. Benefits include reduced risk of infection transmission during examinations.

Clinical Evidence

Bench testing only. Performance data includes watertight testing (1000ml, AQL 2.5), physical dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before/after aging) per ASTM D6319-00a. Biocompatibility testing includes Primary Dermal Irritation and Guinea Pig Sensitization (Buehler) tests. Powder content verified below 2 mg/glove.

Technological Characteristics

Nitrile rubber material; powder-free; blue color. Dimensions: 240 mm minimum length; palm width 73-107 mm depending on size; thickness min 0.08 mm (finger/palm). Physical properties: Tensile strength 23-26 MPa (before aging), 18-24 MPa (after aging); elongation 700-840% (before aging), 660-760% (after aging). Meets ASTM D6319-00a standards.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.

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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KO31580

## GREEN PROSPECT SDN. BHD. (667515-0)

| JUL 2 5 2003 | | APPENDIX-J |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 1.0 | SMDA 510 (K) SUMMARY | |
| 2.0 | Submitter | Green Prospect Sdn Bhd<br>Lot 14803, Kawasan Perindustrian<br>Kg. Acheh, Sitiawan, Lumut<br>Perak Darul Ridzuan<br>MALAYSIA |
| | Tel | 605-6911288 |
| | Fax | 605-6922388 |
| | Name of Contact Person | 1. MS. WONG YOKE CHENG |
| | Date of Summary Prepared | April 23, 2003 |
| 3.0 | Name of Device | |
| | Trade Name: | Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves |
| | Common Name: | Exam Glove |
| | Classification Name: | Patient Examination Glove |
| 4.0 | Identification of The Legally Marketed Devices | |
| | Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of<br>ASTM Standard D6319-00a ³ and FDA requirements. | |
| 5.0 | Description of The Device | |
| | Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of<br>ASTM Standard D6319-00a ³ and FDA Water leak test. | |
| 6.0 | The Intended Use of Glove | |
| | A medical glove is worn on the hand of healthcare and similar personnel to prevent<br>contamination between healthcare personnel and the patient's body, fluids, waste or<br>environment. | |

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## 7.0 Summary of Performance Data:

Performance data of gloves based on ASTM D6319-00a2 and FDA 1000ML watertight test.

| TEST | ASTM D6319-00a3 | POWDER FREE NITRILE EXAM.<br>GLOVES | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------|-----------|
| 1. Watertight (1000ml) | Multiple Normal<br>GI<br>AQL = 2.5 | Pass GI | AQL = 2.5 |
| 2. Length (mm)<br>Size<br>XS<br>S<br>M<br>L<br>XL | Min 220<br>Min 220<br>Min 230<br>Min 230<br>- | 240 mm minimum for all sizes | |
| 3. Palm width (mm)<br>Size<br>XS<br>S<br>M<br>L<br>XL | 70 ± 10<br>80 ± 10<br>95 ± 10<br>111 ± 10<br>- | 73-78<br>83 - 88<br>93 - 98<br>103 - 107 | |
| 4. Thickness (mm)<br>(Single Layer)<br>Finger<br>Palm | Min 0.05<br>Min 0.05 | Min 0.08<br>Min 0.08 | |
| 5. Physical Properties<br>Before Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%)<br>After Aging<br>Tensile Strength (MPa)<br>Ultimate Elongation (%) | Min 14<br>Min 500<br>Min 14<br>Min 400 | 23-26<br>700 - 840<br>18-24<br>660 - 760 | |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove | |

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- The performance data of the glove as shown above meet the ASTM D6319-00a" 8.0 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 concluded that the Multiple Private Labeled Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves, meets:

- ASTM D6319-00a63Standard ・
- FDA pinhole requirements -
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a63

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2003

Green Prospect Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550

Re: K031580

Trade/Device Name: Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove Regulation Number: 21 CFR 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 24, 2003 Received: June 27, 2003

Dear Ms. Tucker:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Tucker

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): 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

SeAWitelson

fer

Susan Runner, DDDS, MA Interim 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 STATEMENT

Green Prospect Sdn Bhd Applicant:

031580 510K Number:

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

Indications for Use:

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Cffluthar

on of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K031580

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use .......................... Per 21 CFR 801.109

OR

Over-The-Counter ...................