← Product Code [LZC](/productcode/LZC) · K173766

# PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs (K173766)

_Shen Wei USA, Inc. · LZC · Jul 8, 2018 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K173766

## Device Facts

- **Applicant:** Shen Wei USA, Inc.
- **Product Code:** [LZC](/productcode/LZC.md)
- **Decision Date:** Jul 8, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for 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 chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.

## Device Story

Disposable nitrile examination glove; black-gray color; features pH coating. Used by healthcare professionals in clinical settings to provide barrier protection against contaminants. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Single-use only. Provides protection during patient examinations; prevents cross-contamination between examiner and patient. Warning: Not for use with Carmustine or Thiotepa due to low breakthrough detection times.

## Clinical Evidence

Bench testing only. Permeation testing performed per ASTM D6978-05 (Reapproved 2013) for nine chemotherapy drugs. Breakthrough detection times reported for all tested agents; Carmustine (27.1 min) and Thiotepa (27.4 min) identified as having low permeation times, resulting in a contraindication for use with these specific drugs.

## Technological Characteristics

Nitrile material; powder-free; pH-coated; black-gray color. Single-use, disposable form factor. Tested for chemotherapy drug permeation per ASTM D6978-05 (Reapproved 2013).

## Regulatory 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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July 8, 2018

Shen Wei USA Inc. Cheryl Reep Compliance Director 33278 Central Ave Ste 102 Union City, California 94587

Re: K173766

Trade/Device Name: PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: June 19, 2018 Received: July 3, 2018

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

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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 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 comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

# Elizabeth F. Claverie -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

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

# Indications for Use

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

### K173766

#### Device Name

Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, 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 chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.

| Chemotherapy Drug and Concentration     | Breakthrough Detection Time in Minutes |
|-----------------------------------------|----------------------------------------|
| 1. Carmustine (BCNU), 3.3mg/ml          | 27.1                                   |
| 2. Cisplatin, 1.0mg/ml                  | >240                                   |
| 3. Cyclophosphamide (Cytoxan), 20mg/ml  | >240                                   |
| 4. Dacarbazine (DTIC) 10mg/ml           | >240                                   |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | >240                                   |
| 6. Etoposide (Toposar), 20mg/ml         | >240                                   |
| 7. Fluorouracil 50mg/ml                 | >240                                   |
| 8. Paclitaxel (Taxol), 6.0mg/ml         | >240                                   |
| 9. Thiotepa, 10mg/ml                    | 27.4                                   |

*Please note that Carmustine (BCNU) has low permeation time of 27.1 minutes and Thiotepa has permeation time of 27.4 minutes.

WARNING: Do not use with Carmustine and Thiotepa.

| 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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**Source:** [https://fda.innolitics.com/device/K173766](https://fda.innolitics.com/device/K173766)

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