POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE

K042805 · Perusahaan Getah Asas Sdn. Bhd. · LZC · Dec 16, 2004 · General Hospital

Device Facts

• Record ID: K042805
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: Dec 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove may provide additional protection in other areas where users are handling certain hazardous chemicals such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Device Story

Disposable blue nitrile patient examination glove; non-sterile. Designed for use by healthcare professionals in clinical settings to prevent cross-contamination between patient and examiner. Provides barrier protection against infectious materials and specific chemotherapy drugs. Permeation testing performed per ASTM F 739 for various chemotherapy agents (e.g., Carmustine, Cisplatin, Cyclophosphamide). Low dermatitis potential verified via Modified Draize Test. Device serves as a protective barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including physical properties, pin-hole freedom, biocompatibility (dermal sensitization, skin irritation, cytotoxicity), and chemotherapy drug permeation testing.

Technological Characteristics

Nitrile material; powder-free; blue color; non-sterile. Complies with ASTM D 6319-00aε,3 (dimensions), ASTM D 412-98 (physical properties), ASTM D 5151-99 (pin-holes), and ASTM D 6124-01 (powder residue). Biocompatibility per ASTM F-720-81, 16 CFR Part 1500, and ISO 10993-5. Chemotherapy resistance per ASTM F 739.

Indications for Use

Indicated for use as a disposable medical glove worn on the hand to provide a barrier against infectious materials, contaminants, and exposure to specific chemotherapy drugs.

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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K042805

Attachment 4

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EC 1 € 2004 ERUSAHAAN GETAH ASAS SDN. BHD. (Company No: 89708-V)

Ammended Copy

## FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information

#### 1.0 Submitter:

Perusahaan Getah Asas Sdn Bhd Lot 1365, Batu 17, Jalan Sungai Sembilang, 45800 Jeram, Selangor Darul Ehsan, Malaysia

| Telephone No .: | [phone] |
|-----------------|----------------|
| Fax No .: | [phone] |

#### 2.0 Contact Person:

| Contact: | Mr Kong Chang TAN |
|----------------|-------------------|
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Name of Device:

Trade Name: Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim)

Common Name: Patient Examination Glove Classification Name: Patient Examination Glove

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

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim), Class I patient examination gloves, Nitrile-80LZC, meets all of the requirements, of ASTM D 6319-00a83 Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 5.0 Description of Device:

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83

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Image /page/1/Picture/0 description: The image shows a logo with the letters "PGA" in white against a black background. The letters are bold and sans-serif. The background is a geometric shape, possibly a hexagon or octagon, with a textured or pixelated appearance. The overall design is simple and high-contrast.

## PERUSAHAAN GETAH ASAS SDN. BHD.

(Company No: 89708-V)

Ammended Copy

#### 6.0 Intended Use of the Device:

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The glove may provide additional protection in other areas where users are handling certain hazardous chemicals such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

#### 7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|-----------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D 6319-00aε,3 | Meets |
| Physical Properties | ASTM D 412-98 | Meets |
| Freedom from pin-holes | ASTM D 5151-99 | Meets |
| Powder Free Residue | ASTM D 6124-01 | Meets |
| Biocompatibility | Dermal Sensitization<br>(as per ASTM F-720-81) | Not a contact skin sensitizer |
| | Primary Skin Irritation Test<br>(as per 16 CFR Part 1500) | Not a primary skin irritant |
| | Cytotoxicity Test<br>(as per ISO 10993-5) | Non cytotoxic |
| Low Dermatitis<br>Potential | Modified Draize Test | Did not induce clinically<br>significant skin irritation nor<br>show any evidence of<br>induced allergic contact<br>dermatitis in human subjects. |

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Image /page/2/Picture/0 description: The image shows a logo with the letters "PGA" in white, set against a dark background. The letters are stylized with a three-dimensional effect, giving them depth and prominence. The logo appears to be part of a larger image, with some dark areas visible in the periphery, suggesting it might be a cropped section of a poster or advertisement.

ERUSAHAAN GETAH ASAS SDN. BHD.

(Company No: 89708-V)

Ammended Copy

| Characteristic | Standards | Device Performance |
|---------------------------------------|------------|--------------------------------------------------------------------------------------|
| Chemotherapy Drugs<br>Permeation Test | ASTM F 739 | Chemotherapy Drug Permeation<br>(average normalized breakthrough time in<br>minutes) |
| | | Carmustine (3.3 mg/mL) 137 |
| | | Cisplatin (1.0 mg/mL) >240 |
| | | Cyclophosphamide (20.0 mg/mL) >240 |
| | | Dacarbazine (DTIC) (10.0 mg/mL) >240 |
| | | Doxorubicin Hydrochloride (2.0 mg/mL) >240 |
| | | 5-Fluorouracil (50.0 mg/mL) >240 |
| | | Etoposide (20.0 mg/mL) >240 |
| | | Paclitaxel (Taxol) (6.0 mg/mL) >240 |
| | | Thio-Tepa (10.0 mg/mL) >240 |

### Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data

The performance test data that support a determination of substantial equivalence are described above.

### Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

Clinical data are not needed for examination gloves.

#### Conclusion 10.0

It can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue It oan of contributed (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) is safe and effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.

labeling claims for the procession in ly equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 € 2004

Mr. KK Leong Ouality Assurance/ Regulatory Affairs Manager Perusahaan Getah Asas Sdn. Bhd. Lot 1365, Batu 17, Jalan Sungai Sembilang, 45800 Jeram, Selangor Darul Ehsan, MALAYSIA

Re: K042805

Trade/Device Name: Powdered Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claims) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: December 2, 2004 Received: December 8, 2004

Dear Mr. Leong:

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 - Mr. Leong

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,

Chiu-Ling, Ph.D.

Chiu Lin, Ph.D. 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

510(k) Number (if known): K042805

Device Name: Powder Free Nitrile Patient Examination Gloves Colour Blue Non-Sterile (with Low dermation Potential and Chemotherapy Drugs Protection Labeling Claims)

Indications For Use: A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ਮ (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)

Qute Mchcin O 12-15-04

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(División Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K042805