POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)

K150340 · Hebei Hongsen Plastics Technology Co, Ltd. · LZA · Jun 18, 2015 · General Hospital

Device Facts

• Record ID: K150340
• Device Name: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
• Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable nitrile rubber examination gloves; worn by clinicians to provide barrier protection against cross-contamination between patient and examiner. Available in four colors (White, Cobalt Blue, Black, Ice Blue) and five sizes (XS-XL). Non-sterile; ambidextrous; smooth surface. Used in clinical settings. Provides physical barrier to reduce transmission of contaminants.

Clinical Evidence

Bench testing only. Compliance verified with ASTM D6319-10 (physical properties), ASTM D5151-06 (freedom from holes), ASTM D6124-06 (residual powder), and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Material: Nitrile rubber. Form factor: Ambidextrous, smooth, disposable gloves. Sizes: XS-XL. Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 2859-1, ISO 10993-10. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands 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 Patient Examination Gloves, Blue Color (k131440)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.

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

June 18, 2015

HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD C/O Mr. Ray Wang Beijing Believe Tech. Service Co., LTD 1-202, Build 3, Beijing New World, No. 5 Chaoyang Rd. Chaoyang District, Beijing, 100024 China

Re: K150340

Trade/Device Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: NITRILE Patient Examination Gloves (Power Free) Regulatory Class: I Product Code: LZA Dated: May 14, 2015 Received: May 18, 2015

Dear Mr. Wang:

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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Page 2 - Mr. Wang

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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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)

K150340

Device Name

POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue)

Indications for Use (Describe)

The POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Exhibit #2 510(k) Summary

The assigned 510(k) Number: k150340

- 1. Date of Preparation: 2015/1/27
- 2. Sponsor

### HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD EASTERN INDUSTRIAL ZONE, NANGONG CITY, HEBEI PROVINCE, CHINA

Contact Person: Mr. ShaoZhang Nan Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. Email: [e-mail]
- Proposed Device Identification 4.

Trade Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Device Name: NITRILE Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves

Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for Use:

The POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

- 5. Predicate Device Identification

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510(k) Number: k131440 Product Name: Powder free Patient Examination Gloves, Blue Color Manufacturer: Hebei HongSen Plastics Technology Co., Ltd.

#### Device Description 6.

The proposed device, POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Powder Free Nitrile Patient Examination Gloves are made of Nitrile rubber; available in four different colors (White, Cobalt Blue, Black, and Ice Blue) and five different sizes (XS-XL). The subject device is provided non-sterile and is a barrier.

#### Non-Clinical Test Conclusion 7.

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.

ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

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#### 8. Substantially Equivalent Comparison Conclusion

| ITEM | Proposed Device (k150340)<br>POWDER FREE Nitrile GLOVES (White,<br>Cobalt Blue, Black, Ice Blue) | Predicate Device (k131440)<br>Powder free Patient Examination Gloves,<br>Blue Color | Remark |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | SE |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SE |
| Class | I | I | SE |
| Indication for<br>use | The POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hands to prevent contamination between<br>patient and examiner. | The Titan powder free nitrile patient<br>examination glove, blue color, is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hands or finger to prevent contamination<br>between patient and examiner. It has blue<br>color and is sold as non-sterile. | SE |
| Powdered or<br>Powder free | Powder free | Powder free | SE |
| Design Feature | ambidextrous, smooth | ambidextrous, smooth | SE |
| Labeling<br>Information | Single-use indication, powder free, device<br>name, glove size and quantity, Nitrile<br>Examination Gloves, Non-Sterile | Single-use indication, powder free, device<br>name, glove size and quantity, Nitrile<br>Examination Gloves, Non-Sterile | SE |

Table III-1 General Comparison

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| Proposed Device (k150340)<br>POWDER FREE Nitrile GLOVES<br>(White) | Designation | Size | | | | | Tolerance | | | | Proposed Device (k150340) | Predicate Device (k131440) | |
|-------------------------------------------------------------------------------------|-------------|----------------|----|----|-----|-----|-----------|--------------------|-----------------|------------|---------------------------------------|---------------------------------|------------|
| | Length, mm | XS | S | M | L | XL | min | ITEM | | | POWDER FREE Nitrile GLOVES | Powder free Patient Examination | Remark |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | | | | (White, Cobalt Blue, Black, Ice Blue) | Gloves, Blue Color | |
| | | Thickness, mm: | | | | | | Colorant | | | White, Cobalt Blue, Black, Ice Blue | Blue | Analysis 3 |
| | Finger | 0.12 | | | | | ±0.03 | | | | 15 MPa, min for White; | | |
| | Palm | 0.10 | | | | | ±0.03 | | Before<br>Aging | Tensile | 15 MPa, min for Cobalt Blue; | | SE |
| | Cuff | 0.09 | | | | | ±0.03 | | | Strength | 15 MPa, min for Black; | 15 MPa, min | |
| Proposed Device (k150340)<br>POWDER FREE Nitrile GLOVES<br>(Cobalt Blue, Black) | Designation | Size | | | | | Tolerance | | | | 15 MPa, min for Ice Blue; | | |
| | Length, mm | XS | S | M | L | XL | min | Physical | | | 500 % min for White; | | |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | | | Ultimate | 500 % min for Cobalt Blue; | | SE |
| | | Thickness, mm: | | | | | | | | Elongation | 500 % min for Black; | 500 % min | |
| | Finger | 0.12 | | | | | ±0.03 | | | | 500 % min for Ice Blue; | | |
| | Palm | 0.10 | | | | | ±0.03 | | | | 14 MPa, min for White; | | |
| | Cuff | 0.09 | | | | | ±0.03 | Properties | | Tensile | 14 MPa, min for Cobalt Blue; | | SE |
| Proposed Device (k150340)<br>POWDER FREE Nitrile GLOVES (Ice<br>Blue) | Designation | Size | | | | | Tolerance | | | Strength | 14 MPa, min for Black; | 14 MPa, min | |
| | Length, mm | XS | S | M | L | XL | min | | After | | 14 MPa, min for Ice Blue; | | |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | | Aging | | 500 % min for White; | | |
| | | Thickness, mm: | | | | | | | | Ultimate | 400 % min for Cobalt Blue; | | Analysis 2 |
| | Finger | 0.10 | | | | | ±0.03 | | | Elongation | 400 % min for Black; | 400 % min | |
| | Palm | 0.08 | | | | | ±0.03 | | | | 400 % min for fro Ice Blue; | | |
| | Cuff | 0.06 | | | | | ±0.03 | | | | Comply with ASTM D6319 | Comply with ASTM D6319 | SE |
| Predicate Device (k131440)<br>Powder free Patient Examination<br>Gloves, Blue Color | Designation | Size | | | | | Tolerance | Freedom from Holes | | | | Be free from holes when tested | |
| | Length, mm | XS | S | M | L | XL | min | | | | Be free from holes when tested in | in accordance with ASTM | SE |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | | | | accordance with ASTM D5151 | D5151 | |
| | | Thickness, mm: | | | | | | | | | | Meet the requirements of ASTM | |
| | Finger | 0.12 | | | | | ±0.03 | Powder Content | | | Max. 0.7 mg per glove | 6319 | SE |
| | Palm | 0.10 | | | | | ±0.03 | | | | | | |
| | Cuff | 0.09 | | | | | ±0.03 | | | | | | |
| Remark | | Analysis 1 | | | | | | | | | | | |

Table III -2 Device Dimensions Comparison

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### Analysis 1:

The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319.

Table III -3 Performance Comparison

Analysis 2:

The proposed device has different Ultimate Elongation after aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.

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| ITEM | Proposed Device (k150340)<br>POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice<br>Blue) | Predicate Device (k131440)<br>Powder free Patient Examination<br>Gloves, Blue Color | Remark | |
|--------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------|----|
| Material | Nitrile | Nitrile | SE | |
| Biocompatibility | Irritation | Under the conditions of the study,<br>not an irritant | Comply with ISO 10993-10 | SE |
| | Sensitization | Under conditions of the study, not a<br>sensitizer. | | |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SE | |

Table III-4Safety Comparison

### Analysis 3:

The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-10, the test results showed that the proposed devices (White, Cobalt Blue, Black, Ice Blue) did not induce skin irritation and showed no significant evidence of causing skin sensitization.

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.