DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K161422 · Wrp Asia Pacific Sdn. Bhd. · LZA · Oct 20, 2016 · General Hospital

Device Facts

• Record ID: K161422
• Device Name: DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable, non-sterile, powder-free blue nitrile patient examination glove. Worn by clinicians to prevent cross-contamination between patient and examiner. Manufactured from synthetic rubber latex with a surface treatment for easy donning. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; ambidextrous design. Provides a barrier against patient fluids and chemotherapy agents, though specific drugs (Carmustine, Thiotepa) have low permeation times requiring caution.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-10 (physical properties), ASTM D6124-06 (powder content), ASTM D5151-06 (watertightness), ASTM D6978-05 (chemotherapy drug permeation), and ISO 10993-10:2010 (biocompatibility/irritation/sensitization).

Technological Characteristics

Material: Synthetic rubber latex (nitrile). Form: Powder-free, blue, finger-textured, ambidextrous. Dimensions: Min 240mm length; 0.07-0.10mm finger thickness. Standards: ASTM D6319-10, ASTM D6978-05, ASTM D6124-06, ASTM D5151-06, ISO 10993-10. Non-sterile. Single-use.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs per ASTM D6978-05.

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.

Predicate Devices

• Dermagrip Powder Free Blue Nitrile Patient Examination Gloves (K141982)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

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

October 20, 2016

WRP Asia Pacific Sdn. Bhd. Sarala Devi Jayaraman Regulatory Affairs Manager Lot 1. Jalan 3. Kaw Perusahaan Bandar Baru Salak Tinggi, Sepang, 43900 MY

Re: K161422

Trade/Device Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 15, 2016 Received: September 21, 2016

Dear Sarala Devi Javaraman:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Ryan -S

for Tina Kiang, Ph.D.

Acting Division Director Division of Anesthesiology, General Hospital, Respiratory Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

### Device Name

Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs

### Indications for Use (Describe)

A 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.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

### Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------------------|---------------|----------------------------------------|
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin Hydrochloride (Adriamycin) | 2.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Cisplatin | 1.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
| Methotrexate | 25mg/ml | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 |

* Please note that the-following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes

| | | | Type of Use (Select one or both, as applicable) | |
|--|--|--|-------------------------------------------------|--|
|--|--|--|-------------------------------------------------|--|

] Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the pata needed and complete and review the collection of information. Send comments regarding this burden estimate or any other spect of this information collection, including suggestions for reducing this burden, to:

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#### 1.0 Submitter:

| Name: | Sarala Devi Jayaraman |
|------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | WRP Asia Pacific Sdn Bhd<br>Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900<br>Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: 17 October 2016

### 2.0 Name of the modified device Identification:

Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs Common Name: Exam Gloves Classification Name: Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC) Patient Examination Gloves (21 CFR 880.6250 product code LZA)

### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed:

| | Predicate |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | WRP Asia Pacific Sdn Bhd |
| Device name | Dermagrip Powder Free Blue Nitrile Patient Examination<br>Gloves, Non-sterile, Tested for use with Chemotherapy<br>Drugs (and various brandnames) |
| 510(k) Number | K141982 |
| MDL | D236305 |
| Regulatory Class | I |
| Product Code | LZC, LZA |

#### 4.0 Description of The Device:

Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile the meets all requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.

The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319-10.

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#### 5.0 Indications of Use:

A 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.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation The following chemicals have been tested with these gloves.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time<br>in Minutes |
|----------------------------------------|---------------|-------------------------------------------|
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin Hydrochloride (Adriamycin) | 2.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Cisplatin | 1.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
| Methotrexate | 25 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |

* Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes

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### Summary of the Technological Characteristics of the Device: 6.0

The Powder Free Blue Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.

Chemotherapy claim is similar to Predicate, which has a glove thickness below 0.10mm and is shorter than 270mm but compliant with the ASTM standards.

## Table 1

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|-------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| | | Predicate | Current |
| Manufacturer(s) | | WRP Asia Pacific<br>Sdn Bhd | WRP Asia Pacific<br>Sdn Bhd |
| 510(k) Number | | K141982 | K161422 |
| Dimensions | ASTM D6319-10 | Min 240mm | Min 240mm |
| Physical Properties | ASTM D6319-10 | Meets | Meets |
| Thickness - Finger | ASTM D6319-10 | 0.07 - 0.10mm | 0.07 - 0.10mm |
| - Palm | | 0.07 - 0.09mm | 0.07 - 0.09mm |
| - Cuff | | 0.06 - 0.08mm | 0.06 - 0.08mm |
| Powder Free | ASTM D6124-06<br>(≤ 2 mg/glove) | Meets | Meets |
| Chemotherapy Drug<br>Permeation Test | ASTM D6978-05 | | |
| Test Chemotherapy Drug | Concentration | | Minimum Breakthrough Detection<br>Time (min) |
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 15.0 | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Doxorubicin Hydrochloride<br>(Adriamycin) | 2.0mg/ml | > 240 | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 | > 240 |
| Cisplatin | 1.0mg/ml | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Methotrexate | 25 mg/ml | - | > 240 |
| Mitomycin C | 0.5 mg/ml | - | > 240 |
| Warning Statement | | * WARNING: Please<br>note that the<br>following drugs<br>have extremely low<br>permeation times:<br>Carmustine (BCNU)<br>: 15 minutes and<br>Thiotepa : 2<br>minutes | * WARNING: Please<br>note that the<br>following drugs have<br>extremely low<br>permeation times:<br>Carmustine (BCNU)<br>: 15 minutes and<br>Thiotepa : 2<br>minutes |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| | | Predicate | Current |
| Biocompatibility | Primary Skin Irritation<br>- | Passes | Passes |
| | ISO 10993-<br>10:2010(E) | Not a primary skin<br>irritant under the<br>conditions of the<br>study. | Not a primary skin<br>irritant under the<br>conditions of the<br>study. |
| | Dermal Sensitization -<br>ISO 10993-<br>10:2010(E) | Passes<br>Not a contact<br>sensitizer under the<br>conditions of the<br>study. | Passes<br>Not a contact<br>sensitizer under the<br>conditions of the<br>study. |
| Watertight (1000ml) | ASTM D5151-06 | Passes | Passes |
| Intended use | - | A patient<br>examination glove<br>is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient<br>and examiner. | A patient<br>examination glove<br>is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient<br>and examiner. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue | Blue |
| Texture | - | Finger textured | Finger textured |
| Size | ASTM D6319-10 | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large |
| Single Use | Medical Glove<br>Guidance Manual -<br>Labeling | Single use | Single use |

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### Substantial Equivalent Based on Assessment of Non-Clinical Performance 7.0 Data

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).

The device and the predicate share the same intended use, same material, same specifications for thickness and length, similar permeation rates for chemotherapy drugs, similar labeling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and water tightness. Thus, the device is substantial equivalent to the predicate.

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

Clinical data was not needed for this device.

#### 9.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K141982.