(200 days)
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.
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.
This document describes the premarket notification (510(k)) for the mCare® Powder-free Nitrile Blue Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, as clinical performance data is not required for this type of device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text includes a table (on page 4 and 5) that compares the characteristics, standards, and device performance of the mCare® Powder-free Nitrile Blue Examination Gloves ("Current") against a predicate device ("Predicate") and relevant ASTM standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE (Current Device - K172930) |
|---|---|---|
| Dimensions | ASTM D6319-10 | Length min 230 mm.Width min 95 ± 10 |
| Physical Properties | ASTM D6319-10 | Before AgingTensile Strength min 14 MPaUltimate Elongation Min 500 %After AgingTensile Strength min 14 MPaUltimate Elongation Min 400 % |
| Thickness | ASTM D6319-10 | Finger min 0.05 mm.Palm min 0.05 mm. |
| Powder Free | ASTM D6319-06 | ≤ 2 mg/glove |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Under the conditions of the study, not an irritant |
| Dermal Sensitization - ISO 10993-10:2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c) (4) | Under the conditions of the study, not a sensitizer | |
| Watertight (1000 ml.) | ASTM D6319-06 | AQL 2.5 |
| Intended use | - | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. |
| Material | ASTM D6319-10 | Nitrile |
| Color | - | Blue |
| Texture | - | Finger texture |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test (e.g., for physical properties, watertightness, biocompatibility). It references ASTM standards, which would dictate the sampling plans. The data provenance is associated with Mercator Medical (Thailand) LTD., located in Thailand, suggesting the tests were conducted or overseen by them. The studies are for a new device seeking clearance, so they are inherently prospective from the device's perspective given the timeframe of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This type of information (number and qualifications of experts) is not relevant or typically included for the testing of examination gloves. The "ground truth" for these tests are objective measurements against established engineering standards (ASTM and ISO).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where there's subjective interpretation by multiple human readers (e.g., radiologists reviewing images). For the performance testing of examination gloves, the tests involve objective measurements against predefined standards. Therefore, an adjudication method is not applicable and not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is completely irrelevant for this device. This device is an examination glove, not an AI-powered diagnostic tool, and it does not involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also not applicable. The device is a physical examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria listed in the table is based on established engineering and material science standards, specifically:
- ASTM D6319-10 (for dimensions, physical properties, thickness, material)
- ASTM D6319-06 (for powder-free and watertightness)
- ISO 10993-10:2010 (E) and Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (for biocompatibility - primary skin irritation and dermal sensitization)
- Medical Glove Guidance Manual - Labeling (for size and single use)
These standards define the acceptable range or threshold for each characteristic based on scientific and industry consensus regarding what constitutes a safe and effective examination glove.
8. The sample size for the training set
There is no "training set" in the context of an examination glove's performance testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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 (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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Form Approved: OMB No. 0910-0120 | |
| Indications for Use | Expiration Date: 06/30/2020See 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) |
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| FORM FDA 3881 (7/17) | Page 1 of 1 |
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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.88/8 Moo 12, Tambon Kampaengphet Amphur RattaphumSongkhla 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).
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 FreeNitrile PatientExamination Glove | mCare® Powder-freeNitrile BlueExamination 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 AgingTensile Strengthmin 14 MPaUltimate ElongationMin 500 %After AgingTensile Strengthmin 14 MPaUltimate ElongationMin 400 % | Before AgingTensile Strengthmin 14 MPaUltimate ElongationMin 500 %After AgingTensile Strengthmin 14 MPaUltimate ElongationMin 400 % |
| Thickness | ASTM D6319-10 | Finger min 0.05 mm.Palm min 0.05 mm. | Finger min 0.05 mm.Palm min 0.05 mm. |
| Powder Free | ASTM D6319-06 | ≤ 2 mg/glove | ≤ 2 mg/glove |
| Biocompatibility | Primary Skin Irritation -ISO 10993-10:2010 (E)& Consumer ProductSafety Commission,Tittle 16, Chapter II, Part1500 | Under the conditionsof the study, not anirritant | Under the conditionsof the study, not anirritant |
| Dermal Sensitization -ISO 10993-10:2010 (E)& Consumer ProductSafety Commission,Tittle 16, Chapter II, Part1500.3(c) (4) | Under the conditionsof the study, not asensitizer | Under the conditionsof the study, not asensitizer | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| Predicate | Current | ||
| Watertight (1000 ml.) | ASTM D6319-06 | AQL 2.5 | AQL 2.5 |
| Intended use | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. | |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue | Blue |
| Texture | - | Finger texture | Finger texture |
| Size | Medical Glove GuidanceManual-Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large |
| Single Use | Medical Glove GuidanceManual-Labeling | Single Use | Single Use |
| Manufacturer(s) | - | LATEXXManufacturing | Mercator Medical(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.
§ 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.