Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy

K173258 · Pt. Medisafe Technologies · KGO · Apr 20, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173258
• Device Name: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
• Applicant: Pt. Medisafe Technologies
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Apr 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.

Device Story

Polychloroprene powder-free sterile surgical glove; synthetic rubber construction. Worn by operating room personnel to provide barrier protection for surgical wounds. Tested for permeation resistance against various chemotherapy drugs (e.g., Carmustine, ThioTEPA, Cisplatin). Provides physical barrier; prevents contamination between patient and clinician. Used in surgical settings.

Clinical Evidence

Bench testing only. Permeation testing performed for 14 chemotherapy drugs per ASTM standards. Breakthrough detection times reported for Carmustine (37.5 min) and ThioTEPA (58.3 min); others >240 min.

Technological Characteristics

Material: Polychloroprene (synthetic rubber). Form factor: Sterile surgical glove. Powder-free. Tested for chemotherapy drug permeation resistance.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 20, 2018

Pt. Medisafe Technologies Deepak Bang Commercial Director J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar, Kecamatan Tanjung Morawa Medan, Indonesia 20362

Re: K173258

Trade/Device Name: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: March 20, 2018 Received: March 23, 2018

Dear Deepak Bang:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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

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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. 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) K173258

#### Device Name

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use With Chemotherapy Drugs

#### Indications for Use (Describe)

This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.

| Test Chemotherapy Drug and Concentration | Breakthrough Detection Time (Minutes) |
|--------------------------------------------------|---------------------------------------|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20.000 ppm) | >240 min |
| Fluorouracil 50.0 mg/ml (50.000 ppm) | >240 min |
| Ifosfamide 50.0 mg/ml (50.000 ppm) | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min |

Caution: Testing showed an average breakthrough time for Carmustine (3.3 mg/ml): 37.5 minutes and average breakthrough time of ThioTEPA (10.0 mg/ml): 58.3 minutes

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

Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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

"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."