POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE

K140418 · Wrp Rubber Products Sdn Bhd · LZA · Sep 3, 2014 · General Hospital

Device Facts

• Record ID: K140418
• Device Name: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
• Applicant: Wrp Rubber Products Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Sep 3, 2014
• 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, ambidextrous patient examination glove; manufactured from synthetic nitrile rubber. Designed for use by healthcare professionals to prevent contamination between patient and examiner. Features finger-textured surface for grip; inner surface treated for ease of donning without powder. Available in multiple sizes (XS-XL). Device functions as a physical barrier; performance verified against ASTM D6319-10 standards for dimensions, physical properties, and thickness, and ASTM D5151-06 for watertightness. Biocompatibility confirmed per ISO 10993-10:2010(E).

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including physical properties (tensile strength, elongation), dimensions, thickness, powder content (ASTM D6124-06), watertightness (ASTM D5151-06), and biocompatibility (ISO 10993-10:2010(E)).

Technological Characteristics

Material: Synthetic nitrile rubber. Standards: ASTM D6319-10 (dimensions, physical properties, thickness), ASTM D6124-06 (powder content), ASTM D5151-06 (watertightness). Biocompatibility: ISO 10993-10:2010(E). Form factor: Ambidextrous, finger-textured, powder-free. Non-sterile.

Indications for Use

Indicated for use as a disposable medical 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

• Dermagrip-N Powder Free Blue Nitrile Examination Gloves (K022904)

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

September 3, 2014

WRP Rubber Products Sdn Bhd Mr. Lim Chin Yit Head of Operations Lot 3, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, Selangor Darul Ehsan MALAYSIA 43900

Re: K140418

Trade/Device Name: Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 10, 2014 Received: July 14, 2014

Dear Mr. Yit:

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. Yit

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,

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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

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## K140418

## 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 on last page.

# 510(k) Number (if known)

K140418

### Device Name

Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile

## 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.

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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### 1.0 Submitter:

| Name: | Mr. Lim Chin Yit |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | WRP Rubber Products Sdn Bhd<br>Lot 3, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,<br>43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |

Date of Summary Prepared: 18 August 2014

#### 2.0 Name of the device:

Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Common Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA)

#### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed:

Dermagrip-N Powder Free Blue Nitrile Examination Gloves 510(k) : K022904 MDL : D036500 Regulatory Class I Product Code : LZA

#### 4.0 Description of The Device:

Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergo surface treatment process to produce a latex. smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

#### 5.0 Intended Use of the Device:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finqer to prevent contamination between patient and examiner.

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# 510(k) SUMMARY

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

The Powder Free Blue Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Predicate | Current |
| Dimensions | ASTM D6319-10 | Meets | Meets<br>Length min 230mm<br>Width min 95±10 |
| Physical Properties | ASTM D6319-10 | Meets | Meets<br><br><b>Before Aging</b><br>Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>Min 500%<br><br><b>After Aging</b><br>Tensile Strength<br>min 14 MPa<br>Ultimate Elongation<br>Min 400% |
| Thickness | ASTM D6319-10 | Meets | Meets<br>Finger min 0.05mm<br>Palm min 0.05mm |
| Powder Free | ASTM D6124-06 | Meets<br>≤ 2 mg/glove | Meets<br>≤ 2 mg/glove |
| Biocompatibility | Primary Skin<br>Irritation -<br>ISO 10993-10:2010(E) &<br>Consumer<br>Product Safety<br>Commission,<br>Tittle 16,<br>Chapter II, Part<br>1500 | Under the<br>conditions of<br>the study, not<br>an irritant | Under the conditions<br>of the study, not an<br>irritant. |
| | Dermal<br>Sensitization -<br>ISO 10993-10:2010(E) &<br>Consumer<br>Product Safety<br>Commission,<br>Tittle 16,<br>Chapter II, Part<br>1500.3(c)(4) | Under the<br>conditions of<br>the study, not<br>a sensitizer. | Under the conditions<br>of the study, not a<br>sensitizer. |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| | | Predicate | Current |
| Watertight (1000ml) | ASTM D5151-06 | Passes | Passes<br>AQL 2.5 |
| Intended use | - | The powder<br>free blue<br>Nitrile<br>examination<br>glove, non-<br>sterile is a<br>disposable<br>device and is<br>made of<br>synthetic<br>rubber<br>intended for<br>medical<br>purposes that<br>is worn on the<br>examiner's<br>hand or finger<br>to prevent<br>contamination<br>between<br>patient and<br>examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue | Blue |
| Texture | - | Finger<br>textured | Finger textured |
| Size | Medical Glove<br>Guidance Manual<br>- Labeling | Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single use | Single use |
| Manufacturer(s) | - | WRP Asia<br>Pacific Sdn<br>Bhd | WRP Rubber Products<br>Sdn Bhd |

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# 510(k) SUMMARY

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for thickness. The current device is thinner than the predicate device, however it meets the ASTM standards.

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

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).

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

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

#### 9.0 Conclusion

Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is as safe and as effective and substantially equivalent to the predicate device.