Powder Free Nitrile (Black) Examination Gloves

K151528 · Gallant Quality Sdn. Bhd. · LZA · Oct 9, 2015 · General Hospital

Device Facts

• Record ID: K151528
• Device Name: Powder Free Nitrile (Black) Examination Gloves
• Applicant: Gallant Quality Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 9, 2015
• 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; worn on hands/fingers by healthcare examiners; prevents cross-contamination between patient and examiner. Device is non-sterile; ambidextrous; powder-free. Performance verified against ASTM D6319-10 standards for dimensions, tensile strength, and elongation. Biocompatibility confirmed via ISO 10993-10:2010 testing (non-irritant, non-sensitizer).

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and adherence to consensus standards (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010).

Technological Characteristics

Material: Nitrile synthetic latex. Form factor: Ambidextrous, powder-free, non-sterile. Standards: ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residual), ISO 10993-10:2010 (biocompatibility).

Indications for Use

Indicated for use as a disposable medical device 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

• Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) (K123116)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.

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

October 9, 2015

Gallant Quality SDN. BHD. Ms. Sumathi Saravana Sami Assistant QA Manager Lot 1874. Jalan Kampung Dew 34700 Taiping, Perak MALAYSIA

Re: K151528

Trade/Device Name: Powder Free Nitrile (Black) Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Regulatory Class: I Product Code: LZA Dated: September 3, 2015 Received: September 9, 2015

Dear Ms. Sumathi Saravana Sami:

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 Radiologic Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K151528

### Device Name

Powder Free Nitrile (Black) Examination Gloves

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)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY K151528

#### 1.0 Submitter :

| Name | : Gallant Quality Sdn. Bhd. |
|-----------|---------------------------------------------------------------------|
| Address | : Lot 1874, Jalan Kampung Dew,<br>34700 Taiping, Perak,<br>Malaysia |
| Phone No. | : 605-847 2777 |
| Fax No . | : 605-847 9108 |

Contact Person : Sumathi Saravana Sami (Ms) : [e-mail] Email 28 September 2015 Date of Preparation:

#### 2.0 Name of the Device

Powder Free Nitrile (Black) Examination Gloves

| Common Name | Nitrile 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:

Primary Predicate:

Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) Company: Worldmed Manufacturing Sdn. Bhd. 510(k): K123116 Regulatory Class I Product Code: LZA

#### 4.0 Description of the Device:

The Powder Free Nitrile (Black) Examination Gloves 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 (Black) Examination Gloves 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 (Black) Examination Gloves are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves

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are made with nitrile and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D6319-10:<br>Length - min. 230mm<br>Width - min. 95 ± 10mm | Meets ASTM D6319-10<br>Standard requirements<br>Minimal value for Length:<br>242 mm<br>Minimal value for Width: 94mm |
| Physical Properties | ASTM D6319-10:<br>Tensile Strength:<br>Before Aging: 14 MPa<br>After Aging: 14 MPA | Meets ASTM D6319-10<br>Standard requirements<br>Tensile Strength:<br>Before Aging: Minimal Value:<br>24.74 MPa<br>After Accelerated Aging:<br>Minimal Value: 31.67 MPa |
| | Ultimate Elongation:<br>Before Aging: min. 500%<br>After Aging: min. 400% | Ultimate Elongation:<br>Before Aging Minimal Value:<br>528%<br>After Aging Minimal Value:<br>439% |
| Thickness | ASTM D6319-10<br>Min 0.05mm | Meets standard requirements<br>Standard requirements<br>Palm - min. 0.09mm<br>Finger - min. 0.13mm |
| Biocompatibility | ISO 10993-10:2010<br>Biological evaluation of<br>medical devices – Part 10:<br>Tests for irritation and skin<br>sensitization | Under the condition of the<br>Study - Not an irritant |
| | ISO 10993-10:2010<br>Biological evaluation of<br>medical devices – Part 10:<br>Tests for irritation and skin<br>sensitization | Under the condition of the<br>Study - Not a sensitizer |
| Freedom from Pinholes | 21 CFR 800.20; ASTM<br>D5151-06<br>AQL 2.5 | Meets 21 CFR 800.20 and<br>ASTM D5151 – 06 Standard<br>Requirements<br>Passes AQL 2.5 |
| Powder Residual | ASTM D6124-06:<br>$\le$ 2 mg/ glove | Meets ASTM D6124-06<br>Standard requirements<br>Minimal Value: 0.32 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 meets 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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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 (Black) Examination Gloves 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<br>and<br>parameters | Worldmed<br>Manufacturing Sdn.<br>Bhd. K123116<br>(Predicate) | Powder Free Nitrile<br>(Black) Examination<br>Gloves<br>(Proposed) | Substantial<br>Equivalence<br>(SE) |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | SE |
| Intended use | Intended for medical<br>purposes that is worn on<br>the examiner's hands or<br>fingers to prevent<br>contamination between<br>patient and examiner. | Intended for medical<br>purposes that is worn on<br>the examiner's hands or<br>fingers to prevent<br>contamination between<br>patient and examiner. | SE |
| Indications for<br>Use Statement | The nitrile examination<br>glove is a disposable<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner | The Powder Free Nitrile<br>(Black) Examination<br>Gloves is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands or fingers to<br>prevent contamination<br>between patient and<br>examiner. | SE |
| Device Material | Nitrile Synthetic Latex | Nitrile Synthetic Latex | SE |
| Color | Black | Black | SE |
| Additives | No flavor additive | No flavor additive | SE |
| Instruction for<br>Use on Labeling | Single Use Only | Single Use Only | SE |
| Construction | Ambidextrous | Ambidextrous | SE |
| Sterility | Non-sterile | Non-sterile | SE |
| Acceptance<br>Criteria | ASTM D6319-10 | ASTM D6319-10 | SE |
| Device Tolerance & Specifications: | | | |
| Dimensions | Meets ASTM D 6319-10 | Meets ASTM D 6319-10<br>Overall Length – min. 230<br>mm<br><br>Width(±10mm)<br>Size XS – 70mm<br>Size S - 80mm<br>Size M - 95mm<br>Size L - 110mm | SE |
| | | Size XL-120mm | |
| | Thickness at Finger - min. 0.05mm<br>Thickness at Palm - min. 0.05mm | Thickness at Finger - min. 0.05mm<br>Thickness at Palm - min. 0.05mm | |
| Physical<br>Properties | Meets ASTM D6319-10: | Meets ASTM D6319-10: | SE |
| | <b>Before Aging</b><br>Tensile strength - min.<br>14.0 MPa<br>Ultimate Elongation - min. 500% | <b>Before Aging</b><br>Tensile strength - min.<br>14.0 MPa<br>Ultimate Elongation - min. 500% | |
| | <b>After Aging</b><br>Tensile Strength - min<br>14.0 MPa<br>Ultimate Elongation - min. 400% | <b>After Aging</b><br>Tensile Strength - min<br>14.0 MPa<br>Ultimate Elongation - min. 400% | |
| Biocompatibility<br>Test<br>a. Irritation<br>Tests<br>b. Skin<br>Sensitization<br>Tests | Under the conditions of the study, not an irritant and contact non-sensitizer. | Under the conditions of the study, not an irritant and contact non-sensitizer. | SE |
| Residual<br>Powder Test | Meets ASTM D6124-06:<br>$\le$ 2 mg/ glove | Meets ASTM D6124-06:<br>$\le$ 2 mg/ glove | SE |
| Freedom from | Meets ASTM D5151-06 | Meets ASTM D5151-06 | SE |

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#### 10.0 Conclusion

The Powder Free Nitrile (Black) Examination Gloves meet all of the requirements of FDArecognized 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 and as effective and performs as well as the legally marketed device.

Based on the comparison of intended use, design, device materials, performance and specification, the Powder Free Nitrile (Black) Examination Gloves are substantially equivalent to the predicate device.