K Number

Device Name

mCare Powder-free Blue Nitrile Examination Gloves

Manufacturer

Mercator Medical (Thailand) LTD.

Date Cleared

2018-04-13

(200 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

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.

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K022548

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary contains no mention of AI or ML.

Therapeutic

No.
Explanation: The device is a disposable examination glove intended to prevent contamination, not to treat or cure any medical condition.

Diagnostic

No
This device is an examination glove, used to prevent contamination between the patient and examiner, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device is a physical examination glove, not a software application. The description clearly states it is a disposable device worn on the hand and made from acrylonitrile-butadiene copolymer dispersion.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The description focuses on the material and specifications for examination gloves, which are physical barriers.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K022548

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: 06/30/2020
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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)	Page 1 of 1
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VI ນາວພາບຸລະນຸປ

510(k) SUMMARY

K172930

Powder Free Nitrile Blue Examination Gloves

1.0 Submitter :

Name :	Dariusz Jan Krezymon (Mr.)
Address :	Mercator Medical (Thailand) LTD.
88/8 Moo 12, Tambon Kampaengphet Amphur Rattaphum
Songkhla 90180. Thailand
Phone Number :	+66 74 584 222
Fax Number :	+66 74 584 223
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).

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.

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
Nitrile Patient
Examination Glove	mCare® Powder-free
Nitrile Blue
Examination Gloves
Dimensions	ASTM D6319-10	Length min 230 mm.
Width min 95 ± 10	Length min 230 mm.
Width min 95 ± 10
Physical Properties	ASTM D6319-10	Before Aging
Tensile Strength
min 14 MPa
Ultimate Elongation
Min 500 %

After Aging
Tensile Strength
min 14 MPa
Ultimate Elongation
Min 400 % | Before Aging
Tensile Strength
min 14 MPa
Ultimate Elongation
Min 500 %

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.

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.