Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr

K170290 · Shen Wei USA, Inc. · LZA · May 24, 2017 · General Hospital

Device Facts

• Record ID: K170290
• Device Name: Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
• Applicant: Shen Wei USA, Inc.
• Product Code: LZA · General Hospital
• Decision Date: May 24, 2017
• 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 purpose that is worn on the examiner's hand to prevent contamination in between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs:

Device Story

Powder-free nitrile examination glove; white outer/black inner color. Designed as disposable barrier protection for medical examiners to prevent cross-contamination between patient and clinician. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; worn on hands. Provides barrier protection during handling of chemotherapy agents; breakthrough times provided for 11 specific drugs to inform clinical safety protocols.

Clinical Evidence

Bench testing only. Device tested for permeation resistance to 11 chemotherapy drugs per ASTM D6978-05. Breakthrough detection times reported for each drug; Carmustine (BCNU) 27.8 minutes; others >240 minutes.

Technological Characteristics

Nitrile material; powder-free; white outer/black inner color. Disposable. Tested per ASTM D6978-05 for chemotherapy drug permeation.

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners to prevent contamination between patient and examiner. Tested for use with 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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

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

May 24, 2017

Shen Wei Usa Inc. Chervl Reep Compliance Manager 33278 Central Ave. Suite 102 Union City, California 94587

Re: K170290

Trade/Device Name: Powder Free Nitrile Exam Glove with pH Coating, White (Outer)-Black (Inner) Color, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 10, 2017 Received: May 10, 2017

Dear Cheryl Reep:

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 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.

# Lori A. Wiggins -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) K 170290

#### Device Name

Powder-Free Nittile Examination Glove with pH coaing, White (Outer)-Black (Inner) Color (Tested For Use With Chemotherapy Drugs)

#### Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination in between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs:

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

| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
|--------------------------------------|----------------------------------------|
| Carmustine (BCNU), 3.3mg/ml | 27.8 |
| Cisplatin, 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan), 20mg/ml | >240 |
| Cyclosporin A, 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10g mg/ml | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| Etoposide (Toposar), 20mg/ml | >240 |
| Fluorouracil 50mg/ml | >240 |
| Paclitaxel (Taxol), 6.0mg/ml | >240 |
| Thiotepa, 10mg/ml | 77.9 |
| Vincristine Sulfate, 1.0mg/ml | >240 |

Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 27.8 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)

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