Powder Free Nitrile Examination Gloves (Blue)

K162113 · Nam Viet Glove Joint Stock Company · LZA · Nov 7, 2016 · General Hospital

Device Facts

• Record ID: K162113
• Device Name: Powder Free Nitrile Examination Gloves (Blue)
• Applicant: Nam Viet Glove Joint Stock Company
• Product Code: LZA · General Hospital
• Decision Date: Nov 7, 2016
• 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 hands or fingers to prevent contamination between patient and examiner.

Device Story

Disposable nitrile synthetic latex examination glove; ambidextrous; non-sterile; blue color. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Device functions as a physical barrier; no active components or software. Performance verified against ASTM D6319-10 standards for dimensions, physical properties (tensile strength, elongation), and thickness. Biocompatibility confirmed via ISO 10993-10 testing (non-irritant, non-sensitizer). Freedom from pinholes verified per ASTM D5151-06 (AQL 2.5). Powder residual levels meet ASTM D6124-06.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including physical property testing (tensile strength, elongation), biocompatibility (irritation and sensitization), freedom from pinholes (AQL 2.5), and residual powder testing, all performed in accordance with FDA-recognized consensus standards.

Technological Characteristics

Material: Nitrile synthetic latex. Form factor: Ambidextrous, blue, powder-free. Standards: ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residual), ISO 10993-10 (biocompatibility). Non-sterile. No energy source or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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

• RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) (K100603)

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.

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

November 7, 2016

Nam Viet Glove Joint Stock Company Ooi Loon Seng OA Manager Hamlet 7, Phuoc Binh Commune Long Thanh District Ho Chi Minh Dong Nai Province, VN 815300

Re: K162113

Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 26, 2016 Received: October 3, 2016

Dear Ooi Loon Seng:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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.

# Michael J. Ryan -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)

### K162113 .

### Device Name

Powder Free Nitrile Examination Gloves (Blue)

### Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

J Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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# 510(k) SUMMARY 510(k) Number: K162113

#### 1.0 Submitter :

Nam Viet Glove Joint Stock Company, Hamlet 7, Phuoc Binh Commune, Long Thanh District 815300, Dong Nai Province, Vietnam.

| Phone No. : | [phone] |
|------------------|----------------------|
| Fax No. : | [phone] |
| Contact Person : | Ooi Loon Seng (Mdm) |
| Email : | [e-mail] |

Date of Preparation : 01 November 2016

#### 2.0 Name of the Device

Powder Free Nitrile Examination Gloves (Blue)

| Common Name | : | Nitrile Patient Exam Gloves |
|---------------------|---|---------------------------------------------|
| Classification Name | : | Patient Examination Gloves (21 CFR 880.6250 |
| Product Code | : | Nitrile — LZA |

#### 3.0 Identification of The Legally Marketed Devices That Equivalency is Claimed:

Predicate Device :

RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) Company : Riverstone Resources Sdn. Bhd. 510(K) : K100603 Requlatory Class I Product Code : LZA

#### 4.0 Description of the Device:

The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 5.0 Intended Use of the Device

The Powder Free Nitrile Examination Glove (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

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

The Powder Free Nitrile Examination Gloves (Blue) are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to

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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)

> physical characteristics, design, product features, and intended use. Both gloves are made with nitrile latex and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.

| CHARACTERISTICS | STANDARDS &<br>ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D6319-10:<br>Length:<br>Size XS & S - min. 220mm<br>Size M & L - min. 230mm | Meets ASTM D6319-10 Standard<br>requirements<br>Minimal Value for Length: 240mm |
| | Width - min. 95 $\pm$ 10mm | Minimal Value for Width: 93mm |
| Physical Properties | ASTM D6319-10:<br>Tensile Strength:<br>Before Aging: 14 MPa<br>After Aging: 14 MPa<br>Ultimate Elongation:<br>Before Aging: min. 500% | Meets ASTM D6319-10 Standard<br>requirements<br>Tensile Strength:<br>Before Aging: Minimal Value:<br>16.20 MPa<br>After Accelerated Aging:<br>Minimal Value: 16.16 MPa<br>Ultimate Elongation:<br>Before Aging Minimal Value: |
| | After Aging: min. 400% | 661%<br>After Aging Minimal Value: 630% |
| Thickness | ASTM D6319-10:<br>Min. 0.05mm | Meets ASTM D6319-10 Standard<br>requirements<br>Palm – Minimal Value: 0.06mm<br>Finger – Minimal Value: 0.13mm |
| Biocompatibility | ISO 10993-10: 2010<br>Biological evaluation of<br>medical devices - Part 10:<br>Tests for irritation and skin<br>sensitization | Pass (Under the conditions of the<br>study, the test article is a non-<br>irritant) |
| Biocompatibility | ISO 10993-10: 2010<br>Biological evaluation of<br>medical devices - Part 10:<br>Tests for irritation and skin<br>sensitization | Pass (Under the conditions of the<br>study, the test article is a non-<br>sensitizer) |
| Freedom from Pinholes | 21 CFR 800.20; ASTM<br>D5151-06<br>AQL 2.5 | Meets 21 CFR 800.20 and ASTM<br>D5151-06 Standard requirements<br>Passes AQL 2.5 |
| Powder Residual | ASTM D6124-06:<br>$\leq$ 2 mg / glove | Meets ASTM D6124-06 Standard<br>requirements<br>Minimal Value: 0.68 mg |

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

The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL.

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

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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)

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

#### 9.0 Substantial Equivalence Comparison

The Powder Free Nitrile Examination Gloves (Blue) is substantially equivalent to the predicate device with respect to intended use, product features and the technological characteristics. The substantial equivalence comparison is presented in the table below:

| Characteristic and<br>parameters | Riverstone Resources Sdn.<br>Bhd. K100603<br>RS Safe Blue Nitrile Medical<br>Examination Gloves Powder<br>Free (Non-Sterile)<br>(Predicate) | Powder Free Nitrile<br>Examination Gloves (Blue)<br>(Proposed) – K162113 | Substantial<br>Equivalence<br>(SE) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | Same |
| Intended use | Intended for medical purposes<br>that is worn on the examiner's<br>hands or fingers to prevent<br>contamination between patient<br>and examiner. | Intended for medical purposes<br>that is worn on the examiner's<br>hands or fingers to prevent<br>contamination between patient<br>and examiner. | Same |
| Indications for Use<br>Statement | A powder free patient<br>examination gloves is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | Same |
| Device Material | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Same |
| Color | Blue | Blue | Same |
| Additives | No flavor additive | No flavor additive | Same |
| Instruction For Use<br>on Labeling | Single Use Only | Single Use Only | Same |
| Construction | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Acceptance Criteria | ASTM D6319-10 | ASTM D6319-10 | Same |

## Device Tolerances & Specifications :

| | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
|------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------|
| Dimensions | Overall Length:<br>Size XS & S - min. 220mm<br>Size M & L - min. 230mm | Overall Length:<br>Size XS & S - min. 220mm<br>Size M & L - min. 230mm | |
| | Width (± 10mm)<br>Size XS - 70mm<br>Size S - 80mm<br>Size M - 95mm<br>Size L - 110mm<br>Size XL - 120mm | Width (± 10mm)<br>Size XS - 70mm<br>Size S - 80mm<br>Size M - 95mm<br>Size L - 110mm<br>Size XL - 120mm | |
| | Thickness at Finger - min.<br>0.05mm | Thickness at Finger - min.<br>0.05mm | |

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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)

| | Thickness at Palm - min.<br>0.05mm | Thickness at Palm - min.<br>0.05mm | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------|
| | Meets ASTM D6319-10 : | Meets ASTM D6319-10 : | |
| Physical Properties | <b>Before Aging</b><br>Tensile Strength – min. 14.0<br>MPa<br>Ultimate Elongation - min.<br>500% | <b>Before Aging</b><br>Tensile Strength – min. 14.0 MPa<br>Ultimate Elongation - min. 500% | |
| | <b>After Aging</b><br>Tensile Strength - min. 14.0<br>MPa<br>Ultimate Elongation - min.<br>400% | <b>After Aging</b><br>Tensile Strength – min. 14.0 MPa<br>Ultimate Elongation - min. 400% | |
| Biocompatibility Test<br>a. Irritation Tests<br>b. Skin<br>Sensitization<br>Tests | Under the conditions of the<br>study, the test article is a non-<br>irritant and non-sensitizer. | Under the conditions of the<br>study, the test article is a non-<br>irritant and non-sensitizer. | Same |
| Residual Powder<br>test | Meets ASTM D6124-06:<br><2 mg / glove | Meets ASTM D6124-06 | Same |
| Freedom from Holes | Meets ASTM D5151-06<br>AQL 2.5 | Meets ASTM D5151-06<br>AQL 2.5 | Same |

#### 10.0 Conclusion

The Powder Free Nitrile Examination Gloves (Blue) meet all of the requirements of FDA-recognized consensus standards; ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10: 2010 and meet our labeling claims and pinhole acceptable quality level (AQL) as shown above.

There are no significant differences between the two products and are identical in terms of intended use, materials and performance.

The conclusion drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.