Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

K172420 · Wear Safe (Malaysia) Sdn. Bhd. · KGO · Sep 29, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172420
• Device Name: Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
• Applicant: Wear Safe (Malaysia) Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable sterile nitrile surgical glove; synthetic rubber construction. Worn by operating room personnel to provide barrier protection for surgical wounds. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Provides protection for healthcare providers handling hazardous chemotherapy agents. No electronic components or software.

Clinical Evidence

Bench testing only. Performance validated via ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Breakthrough detection times provided for 15 chemotherapy agents.

Technological Characteristics

Material: Synthetic nitrile rubber. Form factor: Sterile, powder-free, white-colored surgical glove. Standards: ASTM D6978-05 (chemotherapy permeation). Sterilization: Not specified. No electronic or software components.

Indications for Use

Indicated for use by operating room personnel as a protective barrier to prevent contamination of surgical wounds. Tested for use with specific chemotherapy drugs.

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)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

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

September 29, 2017

Wear Safe (Malaysia) Sdn. Bhd. Cho Sow Fong Regulatory Affairs Manager Lot 5068 & 5069, Batu 4 ½, Jalan Meru, 41050 Klang, Selangor, Malaysia

Re: K172420

Trade/Device Name: Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: August 9, 2017 Received: August 10, 2017

Dear Cho Sow Fong:

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

{1}------------------------------------------------

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 (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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

#### Device Name

Sterile Powder Free Nitrile Surgical Gloved. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

#### Indications for Use (Describe)

Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|-----------------------------------------|------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 78.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 118.8 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

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.

## K172420

Page 1 of 2

PSC Poblishing Services [phone] EF

{3}------------------------------------------------

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

"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."

## K172420

Page 2 of 2