Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves

K171279 · Top Glove Sdn. Bhd. · KGO · Oct 12, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171279
• Device Name: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
• Applicant: Top Glove Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 12, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient. These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.

Device Story

Sterile surgical gloves (latex and nitrile) designed for use by healthcare professionals during surgical procedures; primary function is barrier protection to prevent cross-contamination between patient and clinician. Nitrile variant specifically tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Gloves are worn on hands; provide physical barrier during clinical/surgical tasks. Benefit includes reduction of infection risk and protection of personnel from hazardous chemotherapy agents.

Clinical Evidence

Bench testing only. Includes permeation testing for chemotherapy drugs (Carmustin, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin, Etoposide, Fluorouracil, Paclitaxel, Thiotepa) per ASTM D6978-05.

Technological Characteristics

Materials: Latex and Nitrile. Form factor: Sterile surgical gloves. Standards: ASTM D6978-05 for chemotherapy drug permeation. Powder-free. Single-use.

Indications for Use

Indicated for use by healthcare professionals during surgery to prevent cross-contamination between personnel and patients. Includes nitrile gloves tested for chemotherapy drug permeation.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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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Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

October 12, 2017

Top Glove SDN BHD Noor Akilah Bt Saidin Deputy General Manager, OA Lot 4968. Jalan Teratai. Batu 6. Off Jalan Meru Klang, 41050 MY

Re: K171279

Trade/Device Name: Sterile Latex Surgical Powder Free Gloves: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Surgeon's Gloves Regulatory Class: Class I Product Code: KGO, LZA, LZC Dated: September 13, 2017 Received: September 13, 2017

Dear Noor Akilah Bt Saidin:

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 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

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

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

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, PhD Acting 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)

K171279

#### Device Name

Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs

#### Indications for Use (Describe)

Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.

These gloves are 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 |
|----------------------------|---------------|----------------------------------------|
| Carmustin (BCNU) | 3.3mg/ml | 8.0 |
| Cisplatin | 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 |
| Fluorouracil | 50.0mg/ml | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | >240 |
| Thiotepa | 10.0mg/ml | 16.2 |

* Please note that the following drugs have extremely low permeation times: Carmustin (BCNU) : 8.0 minutes and Thiotepa : 16.2 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.

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 data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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)

K171279

Device Name Sterile Latex Surgical Powder Free Gloves

Indications for Use (Describe)

Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.

| 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) <span style="text-align:right;">☒</span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

information unless it displays a currently valid OMB number."