WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

K141279 · Wanghui Glove Co., Ltd. · LZA · Dec 3, 2014 · General Hospital

Device Facts

• Record ID: K141279
• Device Name: WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
• Applicant: Wanghui Glove Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Nitrile examination gloves; non-sterile; disposable. Function as physical barrier against body fluids and bloodborne pathogens. Material properties allow for hand conformation and movement during medical procedures. Used in clinical settings by healthcare providers. Protects both patient and examiner from contamination. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Compliance demonstrated via ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residual), and ISO 10993-10 (biocompatibility/skin irritation/sensitization).

Technological Characteristics

Nitrile rubber material. Non-sterile. Powder-free with surface coating agent. Dimensions and physical properties conform to ASTM D6319-10. Freedom from pinholes per ASTM D5151-06 (AQL 2.5). Residual powder <2mg/glove per ASTM D6124-06. Biocompatibility per ISO 10993-10.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn on the examiner's hand or finger to prevent cross-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

• Nitrile Powder Free Patient Examination Gloves, Blue Color (K120970)

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

December 3, 2014

Wanghui Glove Co., Ltd. C/O Mr. Chu Xiaoan Official Correspondent Rm. 1606, Bldg.1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA

Re: K141279 Trade/Device Name: Nitrile Powder Free Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LZA Dated: October 28, 2014 Received: October 30, 2014

### Dear Mr. Xiaoan:

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.

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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-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K141279

Device Name

Nitrile Powder Free Patient Examination Gloves, Blue Color

Indications for Use (Describe)

Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

| 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.

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#### Section 6 510(k) Summary

# 510(K) Summary

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: K141279 ..

### Premarket Notification [510(k)] Summary

#### 1.0 Submitter:

| Submitter's name : | Wanghui Glove Co., Ltd. |
|-------------------------|-----------------------------------------------------------------------------|
| Submitter's address : | Cuizhuang, Pachigang Town, Luannan<br>County, Hebei Province, 063502, China |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86) 315-4430333 |
| Name of contact person: | Zhang Liang |
| Date of preparation : | 2014-10-28 |

#### 2.0 Name of the Device

| Device Name: | Nitrile Powder Free Patient Examination<br>Gloves, Blue Color |
|-------------------------|---------------------------------------------------------------|
| Proprietary/Trade name: | Nitrile Powder Free Patient Examination<br>Gloves, Blue Color |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |

### 3.0 Predicate device

| Device Name: | Nitrile Powder Free Patient Examination Gloves,<br>Blue Color |
|----------------|---------------------------------------------------------------|
| Company name: | Tangshan Zhonghong Pulin Plastic Co.,Ltd. |
| 510(K) Number: | K120970 |

### 4.0 Device Description:

#### 4.1 How the device functions:

Nitrile films form a barrier to body fluids and bloodborne Pathogens

#### 4.2 Scientific concepts that form the basis for the device

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

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#### 4.3 Physical and performance characteristics such as design, materials and physical properties:

Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

## 5.0 Device Intended Use (Indication for use):

Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## 6.0 Summary of the Technological Characteristics of the Device:

The Nitrile Powder Free Patient Examination Gloves, Blue Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard | Device performance |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Dimension | ASTM standard D 6319-10. | Meets |
| Physical Properties | ASTM standard D 6319-10. | Meets |
| Freedom<br>from<br>pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319-10 and<br>D6124-06(Reapproved 2011). | Meets<br><2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits<br>ISO 10993-10: Third Edition<br>2010-08-01.<br>Dermal sensitization in the<br>guinea pig ISO 10993-10: Third<br>Edition 2010-08-01. | Passes<br>Not a Primary Skin<br>Irritation<br>Passes<br>Not a Dermal<br>sensitization |

## 7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

Nitrile Powder Free Patient Examination Gloves, Blue Color, meet requirements per ASTM D6319-10.per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: Third Edition 2010-08-01.

The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

#### Substantial Equivalent Based on Assessment of Clinical Performance Data: 8.0

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

| Features &<br>Description | Predicate Device | Subject Device | Result<br>Comparison |
|---------------------------|-----------------------------------------------|-------------------------|----------------------|
| Company | Tangshan Zhonghong Pulin<br>Plastic Co., Ltd. | Wanghui Glove Co., Ltd. | -- |
| 510(K) Number | K120970 | K141279 | |

#### 9.0 Substantial Equivalence Comparison:

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| Product name | Nitrile Powder Free Patient Examination Gloves, Blue Color | Nitrile Powder Free Patient Examination Gloves, Blue Color | same |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Code | LZA | LZA | same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | same |
| Intend for use | Nitrile Powder Free Patient Examination Gloves, Blue Color 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. | Nitrile Powder Free Patient Examination Gloves, Blue Color 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. | Substantially equivalent |
| Device Description and Specifications | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Substantially equivalent |
| Dimensions --Length | Meets ASTM D6319-10<br>≥230mm min | 230mm min for all sizes | Substantially equivalent |
| Dimensions -- Width | Meets ASTM D6319-10<br>Small 70-90 mm<br>Medium 85-105mm<br>Large 100-120mm<br>Xlarge 110-130 mm | Small 83-86 mm<br>Medium 92-98mm<br>Large 105-109mm<br>X large 113-119 mm | Substantially equivalent |
| Dimensions --Thickness | Meets ASTM D6319-10<br>Finger 0.05mm min.<br>Palm 0.05mm min. | Thickness (mm) min.<br>Finger 0.10 mm min.<br>Palm 0.06 mm min. | Substantially equivalent |
| Physical Properties | Meets ASTM D D6319-10<br>Before aging/after aging<br><br>Elongation ≥500%<br>Tensile Strength≥ 14MPa | Before aging/after aging<br><br>Elongation :520-580%<br>Tensile Strength:22-34 MPa | Substantially equivalent |
| Freedom from Pinholes | Meets<br>• 21 CFR 800.20<br>• ASTM D6319-10<br>• ASTM D 5151-06<br>(Reapproved 2011) | Meets ASTM D5151-06<br>(Reapproved 2011)<br>Holes at Inspection Level I AQL2.5 | Substantially equivalent |
| Residual Powder | Meets ASTM D 6124-06<br>(Reapproved 2011)<br><br>below 2mg of residual powder | Meets ASTM D 6124-06<br>(Reapproved 2011)<br>Results generated values below 2mg of residual powder | Substantially equivalent |
| Materials used to fabricate the devices | Nitrile | Nitrile | Substantially equivalent |
| Dusting or Donning Powder: | PU | PU | Substantially equivalent |
| Dusting or Donning Powder: name | PU | Surface Coating Agent | Substantially equivalent |
| Compare performance | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Substantially equivalent |
| data supporting<br>substantial<br>equivalence | (Reapproved 2011)<br>ASTM D6319-10<br>ASTM D6124-06<br>(Reapproved 2011) | (Reapproved 2011)<br>ASTM D6319-10<br>ASTM D6124-06<br>(Reapproved 2011) | |
| Single Patient<br>Use | Single Patient Use | Single Patient Use | Substantially<br>equivalent |
| Biocompatibility | Under the conditions of this<br>study, the test article was a<br>non-irritant and non-sensitizer.<br><br>SKIN IRRITATION DERMAL<br>and SENSITIZATION<br>STUDIES Meets ISO<br>10993-10:2002/Amd.1:2006 | Under the conditions of this<br>study, the test article was a<br>non-irritant and non-sensitizer.<br><br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION STUDIES<br>Meets ISO 10993-10: Third<br>Edition 2010-08-01. | Substantially<br>equivalent |
| Labeling for the<br>legally marketed<br>device to which<br>substantial<br>equivalence is<br>claimed. | -Powder Free<br>-Patient Examination Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non sterile | -Powder Free<br>-Patient Examination Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>-Blue color<br>- Non sterile | Substantially<br>equivalent |

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#### Substantial Equivalence Comparison: 10.0

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue Color is as safe, as effective, and performs as well as the predicate device, Nitrile Powder Free Patient Examination Gloves, Blue Color, Tangshan Zhonghong Pulin Plastic Co.,Ltd.. K120970.