POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE

K093500 · Wear Safe (Malaysia) Sdn. Bhd. · LZC · Jan 19, 2010 · General Hospital

Device Facts

• Record ID: K093500
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
• Applicant: Wear Safe (Malaysia) Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: Jan 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile (Chemotherapy Drug Protection Labeling Claim) is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.

Device Story

Disposable nitrile examination gloves; non-sterile; white or blue. Worn on hands by healthcare personnel to provide barrier protection against infectious materials, contaminants, and chemotherapy drugs. Device functions as physical barrier; tested for permeation breakthrough times against specific chemotherapy agents (e.g., Carmustine, Cisplatin, Cyclophosphamide). Used in clinical settings; provides protection to the wearer during patient examination and handling of hazardous drugs.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing including ASTM D6319 (dimensions, physical properties), ASTM D5151 (pin-holes), ASTM D6124 (powder residue), and chemotherapy drug permeation testing.

Technological Characteristics

Synthetic nitrile material; powder-free. Complies with ASTM D6319, ASTM D412, ASTM D5151, and ASTM D6124. Biocompatibility per ASTM F720-81 and 16 CFR Part 1500. Non-sterile.

Indications for Use

Indicated for use as a disposable, non-sterile, synthetic nitrile glove worn on the hand by healthcare personnel to provide a barrier against infectious materials, contaminants, and 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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K093500

V S Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)

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

### 1.0 Submitter:

WEAR SAFE (MALAYSIA) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru, 41050 Klang, Selangor Darul Eshan, Malaysia.

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

#### 2.0 Contact Person:

| Contact: | Mr. SH TAN |
|----------------|---------------------|
| E-mail: | [e-mail] |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

# 3.0 Name of Device:

.

.

.

Trade Name:

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored). Non-Sterile (Chemotherapy Drug Protection Labeling Claim) Patient Examination Glove Common Name: Classification Name: Patient Examination Glove.

### Identification of The Legally Marketed Device: 4:0

The Powder Free Nitrile Examination Gloves, White (non colored) or Blue (colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim), Class I Patient Examination gloves, 80LZC. meets all of the requirements of ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 5.0 Description of Device:

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile (Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D6319.

Lot 13726, Jalan Haji Salleh, Batu 5% Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]

Page 1 of 3

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K093500

# Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)

# 6.0 Intended Use of the Device:

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile (Chemotherapy Drug Protection Labeling Claim) is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.

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

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile (Chemotherapy Drug Protection Labeling Claim) possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Dimensions | ASTM D6319 -<br>00a(2005)e1 | Meets |
| Physical Properties | ASTM D 412 - 06ae1 | Meets |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Biocompatibility | Dermal Sensitization<br>(as per ASTM F720-81)<br><br>Primary Skin Irritation Test<br>(as per 16CFR Part1500) | Not a contact skin sensitizer<br><br>Not a primary skin irritant |

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

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

# 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data are not needed for market cleared examination gloves.

Lot 13726, Jalan Haji Salleh, Batu 5% Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]

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#### 10.0 Conclusion

It can be concluded that the Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored) or, Non Sterile (Chemotherapy Drug Protection Labeling Claim) is safe and effective for use 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.

Consequently, this device is substantially equivalent to current marketed devices. This summary will include any other information reasonably deemed necessary by the FDA.

Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 1 9 2010

Mr. S.H. Tan Regulatory Affairs Department Manager Wear Safe MALAYSIA Sdn. Bhd. Lot PT 13726, Jalan Haji Salleh off Jalan Meru Klang Selangor Darul Ehsan MALAYSIA 41050

Re: K093500

Trade/Device Name: Powder Free Nitrile Examination Gloves, White (non-colored) or Bule (colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim) Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: December 23, 2009 Received: December 29, 2009

Dear Mr. Tan:

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: CDRH 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 Federal Register.

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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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Gunner

Anthony D. Watson, BS, MS, MBA 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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K093500

Wear Safe (Malaysia) Sdn.Blid. (Company No.204396-X)

revised copy

# INDICATIONS FOR USE

Applicant: WEAR SAFE (MALAYSIA) SDN. BHD.

# 510(k) Number (if known): K093500

Device Name: Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim)

Indication For Use: A powder free nitrile examination glove is a disposable device made of synthetic material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.

| Powder Free Nitrile Patient Examination Gloves, White (Non-Colored) Non Sterile (Chemotherapy Drugs | |
|-----------------------------------------------------------------------------------------------------|-------|
| Protection Claim): | |
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes | |
| The following chemotherapy drugs have been tested: | |
| Carmustine (BCNU) (3.3mg/ml) | 71.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (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 (Toposar) (20.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| ThioTepa (10.0 mg/ml) | 72.36 |

Powder Free Nitrile Patient Examination Gloves, Blue (Colored) Non sterile (Chemotherapy Drugs Protection Claim):

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes The following chemotherapy drugs have been tested:

| The following chemotherapy drugs have been tested. | |
|----------------------------------------------------|------|
| Carmustine (BCNU) (3.3mg/ml) | 60.7 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (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 (Toposar) (20.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| ThioTepa (10.0 mg/ml) | 69.0 |

. Lot 13726, Jalan Haji Salleh, Batu 5% Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]

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KD93500

WSM Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)

revised copy

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X AND/OR (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)

Elizabeth P. Clavier Will

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

510(k) Number. K093500

Page 2 of 2

Lot 13726, Jalan Haji Salleh, Batu 5% Off Jalan Meru, 41050 Klang, Selangor Darul Ebsan Malaysia. Tel: [phone], Fax: [phone]