Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

K162312 · Shen Wei USA, Inc. · LZA · Jul 25, 2017 · General Hospital

Device Facts

• Record ID: K162312
• Device Name: Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
• Applicant: Shen Wei USA, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination glove; coated with Aloe Vera; green color. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Manufactured using online chlorination for donning properties. Available in sizes XS through XXL. Single-use only. Provides a physical barrier; does not function as a chemical barrier. Biodegradable in landfill environments per ASTM D5526-94.

Clinical Evidence

No clinical testing was performed. Bench testing only, including physical properties, dimensions, freedom from pinholes (ASTM D5151-11), and biocompatibility (ISO 10993-10:2010).

Technological Characteristics

Material: Nitrile Butadiene Rubber. Design: Ambidextrous, beaded cuff, green color, Aloe Vera coating. Standards: ASTM D6319-10 (physical/performance), ASTM D5151-11 (pinholes), ASTM D5526-94 (biodegradation). Manufacturing: Online chlorination. Non-sterile. Shelf life: 3 years.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner.

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.

Predicate Devices

• POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA GREEN (K993876)

Submission Summary (Full Text)

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

July 25, 2017

Shen Wei USA Inc. Cheryl Bailey-Kroll Compliance Manager 33278 Central Ave Ste 102 Union City, California 94587

Re: K162312

Trade/Device Name: Biodegradable Powder Free Nitrile Exam Gloves With Aloe Vera. Green Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 20, 2017 Received: July 21, 2017

Dear Cheryl Bailey-Kroll:

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 (reporting of medical device

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related 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 yours,

Tara A. Ryan -S

for Lori Wiggins, MPT, CLT 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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# Indications for Use

510(k) Number (if known)

### K162312

Device Name

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

Indications for Use (Describe)

The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

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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Image /page/3/Picture/0 description: The image shows a logo for Shen Wei USA Inc. The logo features a green hand above the company name, with the words "Shen Wei" in a larger, bolder font than "usa inc." Below the company name, there is a colorful line with the words "PROMOTING YOUR SUCCESS!" in red.

## 510K# K162312 SUMMARY

#### 1.0 Submitter:

| Name: | Shen Wei USA Inc. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 33278 Central Ave. Suite 102<br>Union City, CA. 94587 |
| FDA Est Reg#: | 2939388 |
| Phone No: | 510-429-8692 |
| Fax No: | 510-487-5347 |
| Manufacturers: | |
| Name: | ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD |
| Address: | XIZHANG TOWN<br>ZHANGJIAGANG CITY, CHINA 215614 |
| FDA Est Reg#: | 1000254914 |
| Phone No: | 520-845-0023 |
| Fax No: | 520-845-0311 |
| Name: | ZHENJIANG SUHUI LATEX PRODUCTS CO.LTD. |
| Address: | LIANHE CHUN, YANGZHONG CITY, JIANGSU 212212, CHINA |
| FDA Est Reg#: | 9615498 |
| Name: | NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. |
| Address: | WORKSHOP UNIT 21 & 27, MID. & SML. SZ. ENT. DEVELOPMENT PARK, NINGXIA HIGH TECH DEVELOPMENT ZONE YINCHUAN, NINGXIA, Area II, CHINA |
| FDA Est Reg#: | 3008932202 |

Date 510k Summary was prepared 07/20/17

#### 2.0 Contact Person:

| Name: | Cheryl Reep |
|-----------|----------------------|
| Phone No: | 510-429-8692 |
| Fax No: | 510-487-5347 |
| Email: | [e-mail] |

#### 3.0 Name of the device:

| Trade Name: | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color |
|----------------------|---------------------------------------------------------------------------|
| Device Name: | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient examination glove |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA |

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#### 4.0 Predicate Device Information:

The predicate device is K993876, POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA GREEN, approved on 2/7/2000. Class I Powder Free Nitrile Examination gloves, 80LZA, which meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20.

#### 5.0 Description of the Device:

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The gloves are coated with Aloe Vera, ambidextrous with beaded cuff, green colored, single use disposable devices that comes in six sizes (XS, S, M, L, XL and XXL) supplied in non-sterile state. The qloves are powder free and are manufactured using online chlorination process to avoid sticky surface and obtain good donning properties.

The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.

#### 6.0 Intended Use of the Device:

The Biodegradable Powder Free Nith Aloe Vera, Green Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

- 7.0 Shelf Life or Expiration Data: Glove's shelf life is 3 years.
#### 8.0 Summary of the Technological Characteristics of the Device:

The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standards | Device Performance |
|---------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Dimensions | ASTM D6319-10 | Meets Standard Requirements |
| Physical Properties (Before/After<br>Aging) | ASTM D6319-10 | Meets Standard Requirements |
| Freedom from pinholes | ASTM D6319-10 / ASTM D5151-<br>11 | Meets Standard Requirements |
| Biocompatibility | ISO 10993-10:2010:<br>i. Primary Skin Irritation in<br>Rabbits | Not a skin irritant under the conditions<br>of study. |
| | ii. Dermal Sensitization | Not a contact sensitizer under the<br>conditions of the study. |

#### Discussion of Similarities and Differences 9.0

The table below shows similarities and differences between the proposed new device.

| Characteristics | Predicate Device | Proposed New Device |
|-----------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Name | K993876, Powder Free Nitrile Exam<br>Gloves with Aloe Vera, Green Color | Biodegradable Powder Free Nitrile Exam<br>Gloves with Aloe Vera, Green Color |

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| Device Description/<br>Regulation Number | Patient examination glove / 21 CFR<br>880.6250 | Patient examination glove / 21 CFR 880.6250 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA |
| Intended use | Intended for medical purpose that is<br>worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner. | Intended for medical purpose that is worn on<br>the examiner's hand to prevent contamination<br>between patient and examiner. This device is<br>single use only. |
| Instruction for Use | A disposable device intended for<br>medical purpose that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. This device is not intended<br>to be used as a chemical barrier. | A disposable device intended for medical<br>purpose that is worn on the examiner's hand<br>to prevent contamination between patient and<br>examiner. This device is single use only. |
| Materials | Nitrile | Nitrile |
| Color / Coating | Green / Aloe Vera | Green / Aloe Vera |
| Design | Ambidextrous in different sizes per<br>ASTM 6319-00 dimensions'<br>requirement | SAME |
| Biodegradation Properties | None | Biodegradable, Difference |
| Performance: | | |
| I. Freedom from Holes | Meets ASTM D6319-00 | Meets Standard Requirements |
| II. Dimension | Meets ASTM D6319-00 | Meets Standard Requirements |
| III. Physical Properties | Meets ASTM D6319-00 | Meets Standard Requirements |
| IV. Powder Residue | Meets < 2mg/glove | Meets Standard Requirements < 2mg/glove |
| Single Use | Yes | Yes |
| Biocompatibility Test | i Not a primary skin irritant<br>ii. Not a contact sensitizer | Not a primary skin irritant nor a contact<br>sensitizer under the conditions of study. |

### Summary of Difference and Comparison of Safety and Effectiveness- The subject device differs from the predicate in that:

- The subject device has biodegradation property within landfills tested per ASTM D5526-94 while the predicate device does not have same technological feature. The difference in biodegradation properties does not affect the subject device's safety and effectiveness; subject device met the requirements for Biocompatibility Testing and ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The difference in technological feature does not change the performance or affect the intended use of the device.
- . Biodegradability is not a medical claim and therefore was not reviewed by FDA.
- Summary of Clinical Testing: Not applicable. No clinical testing was performed. 10.0
- 11.0 Conclusion: The conclusion drawn from the non-clinical test demonstrate that the subject device, Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color, is as safe, as effective, and performs as well as the legally marketed device.