mCare Powder-free Blue Nitrile Examination Gloves

K172930 · Mercator Medical (Thailand), Ltd. · LZA · Apr 13, 2018 · General Hospital

Device Facts

• Record ID: K172930
• Device Name: mCare Powder-free Blue Nitrile Examination Gloves
• Applicant: Mercator Medical (Thailand), Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

mCare® Powder-free Nitrile Blue Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn by healthcare examiners; prevents cross-contamination between patient and examiner. Manufactured from acrylonitrile-butadiene copolymer; blue color; powder-free; finger-textured. Used in clinical settings; non-sterile. Provides physical barrier protection; performance verified against ASTM D6319-10 standards for dimensions, physical properties (tensile strength, elongation), thickness, and watertightness (AQL 2.5).

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, specifically adherence to ASTM D6319-10 standards for physical properties, dimensions, thickness, and watertightness, as well as biocompatibility testing (ISO 10993-10:2010 for skin irritation and sensitization).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Standards: ASTM D6319-10 (dimensions, physical properties, thickness, material), ASTM D6319-06 (powder-free, watertightness). Biocompatibility: ISO 10993-10:2010. Form factor: Blue, powder-free, finger-textured, disposable, non-sterile. Sizes: XS to XL.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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

• MEDTEXX Blue Color Powder Free Nitrile Rubber Examination Gloves (K022548)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 13, 2018

Mercator Medical (Thailand) LTD. Dariusz Krezymon Managing Director 88/2 Moo 12 Tambon Kampaengphet Amphur Rattaphum, Thailand

Re: K172930

Trade/Device Name: mCare Powder-free Nitrile Blue Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: March 16, 2018 Received: March 23, 2018

Dear Dariusz Krezymon:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

### Geeta K. Pamidimukkala -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 | |
| | Form Approved: OMB No. 0910-0120 |
| <i>Indications for Use</i> | Expiration Date: 06/30/2020<br>See PRA Statement below. |

| 510(k) Number (if known) | K172930 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | mCare® Powder Free Nitrile Blue Examination Glove |
| Indications for Use (Describe) | mCare® Powder Free Nitrile Blue Examination Glove are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. |

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

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VI ນາວພາບຸລະນຸປ

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### 510(k) SUMMARY

### K172930

### Powder Free Nitrile Blue Examination Gloves

#### 1.0 Submitter :

| Name : | Dariusz Jan Krezymon (Mr.) |
|----------------|-------------------------------------------------------------------------------------------------------------------|
| Address : | Mercator Medical (Thailand) LTD.<br>88/8 Moo 12, Tambon Kampaengphet Amphur Rattaphum<br>Songkhla 90180. Thailand |
| Phone Number : | [phone] |
| Fax Number : | [phone] |
| Date: | April 11, 2018 |

#### 2.0 Name of Device :

mCare® Powder-free Nitrile Blue Examination Gloves Common Name: Nitrile Blue Powder Free Examination Gloves Classification Name : Patient Examination Gloves

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

MEDTEXX Blue Color Powder Free Nitrile Rubber Examination Gloves, 510(k): K022548 Regulatory Class I Product Code : LZA

#### 4.0 Description of The Device :

mCare® Powder-free Nitrile Blue Examination Gloves are substantially equivalent to the Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250).

They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion.

These gloves are blue in color and are powder free.

#### Intended Use of the Device : 5.0

mCare® Powder-free Nitrile Blue Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

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

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

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Predicate | Current |
| 510(k) Number | | K022548 | K172930 |
| Name of Device | | Blue Powder Free<br>Nitrile Patient<br>Examination Glove | mCare® Powder-free<br>Nitrile Blue<br>Examination Gloves |
| Dimensions | ASTM D6319-10 | Length min 230 mm.<br>Width min 95 ± 10 | Length min 230 mm.<br>Width min 95 ± 10 |
| Physical Properties | ASTM D6319-10 | <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 % | <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 | Finger min 0.05 mm.<br>Palm min 0.05 mm. | Finger min 0.05 mm.<br>Palm min 0.05 mm. |
| Powder Free | ASTM D6319-06 | ≤ 2 mg/glove | ≤ 2 mg/glove |
| Biocompatibility | Primary Skin Irritation -<br>ISO 10993-10:2010 (E)<br>& Consumer Product<br>Safety Commission,<br>Tittle 16, Chapter II, Part<br>1500 | Under the conditions<br>of the study, not an<br>irritant | Under the conditions<br>of the study, not an<br>irritant |
| | Dermal Sensitization -<br>ISO 10993-10:2010 (E)<br>& Consumer Product<br>Safety Commission,<br>Tittle 16, Chapter II, Part<br>1500.3(c) (4) | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions<br>of the study, not a<br>sensitizer |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| | | Predicate | Current |
| Watertight (1000 ml.) | ASTM D6319-06 | AQL 2.5 | AQL 2.5 |
| Intended use | | 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<br>between 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 to<br>prevent contamination<br>between patient and<br>examiner. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue | Blue |
| Texture | - | Finger texture | Finger texture |
| Size | Medical Glove Guidance<br>Manual<br>-Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large |
| Single Use | Medical Glove Guidance<br>Manual<br>-Labeling | Single Use | Single Use |
| Manufacturer(s) | - | LATEXX<br>Manufacturing | Mercator Medical<br>(Thailand) LTD. |
| Conclusion | | | Similar |

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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods its 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

mCare® Powder-free Nitrile Blue Examination Gloves performs according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards. Consequently, the device is as safe and as effective and performs as well as or better than the predicate device.