(178 days)
Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color have Finger Texture, Ambidextrous, single-use, and are powderfree. The product is non-sterile.
The provided document K222813 describes the acceptance criteria and the study that proves the Ecoglove Nitrile Examination Gloves meet these criteria.
Here's the detailed breakdown:
1. A table of acceptance criteria and the reported device performance:
| SI No. | Tests | Proposed Device Actual Data | Acceptance Criteria |
|---|---|---|---|
| 1. | Dimension: Length, Width and Thickness (ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application) | Length: S: 243 mm, M: 242.30 mm, L: 243.30 mm, XL: 243.07 mm Width: S: 84.92 mm, M: 95.30 mm, L: 110.53 mm, XL: 120.62 mm Thickness: Palm S: 0.086 mm, M: 0.086 mm, L: 0.085 mm, XL: 0.085 mm Finger S: 0.115 mm, M: 0.110 mm, L: 0.115 mm, XL: 0.115 mm | Length: S: 220mm min (M, L, XL not explicitly listed but implied to be similar to predicate of 230mm min) Width: S: 80 mm±10, M: 95 mm ±10, L: 110 mm ±10, XL: 120 mm ±10 Thickness: Palm: 0.05 mm min, Finger: 0.05 mm min |
| 2. | Physical property: Tensile strength and Ultimate Elongation (ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application) | Tensile strength (Before aging): S: 17.44 MPa, M: 17.60 MPa, L: 16.75 MPa, XL: 16.03 MPa Tensile strength (After aging): S: 16.52 MPa, M: 16.79 MPa, L: 15.48 MPa, XL: 15.07 MPa Ultimate elongation (Before aging): S: 519%, M: 521%, L: 565%, XL: 550% Ultimate elongation (After aging): S: 511%, M: 511%, L: 510%, XL: 514% | Tensile strength: 14 MPa Min for all sizes (Before and After aging) Ultimate elongation: 500% Min for all sizes (Before aging), 400% Min for all sizes (After aging) |
| 3. | Detection of Holes in Medical Gloves (ASTM D6319-19 / ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves) | AQL 2.5 (for all sizes) | AQL 2.5 |
| 4. | Powder-Free Residue (ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves) | S: 0.02 Mg/glove, M: 0.01 Mg/glove, L: 0.01 Mg/glove, XL: 0.01 Mg/glove | ≤ 2 mg/Glove Max |
| Biocompatibility Tests: | |||
| 1. | In Vitro Cytotoxicity | Fail | Non-cytotoxic |
| 2. | Skin Sensitization | Pass | Non-sensitizer |
| 3. | Skin Irritation | Pass | Non-irritant |
| 4. | Acute Systemic Toxicity | Pass | Nontoxic |
Note: For the "In Vitro Cytotoxicity" test, the proposed device failed the initial acceptance criteria of being "Non-cytotoxic". However, the document includes a note (Note1 in Table 1) stating: "Additional testing was performed to determine if this was a systemic toxicity concern." This implies that while the initial in vitro result was
considered "Fail" against the direct "Non-cytotoxic" criterion, further investigation might have clarified that it does not pose a systemic toxicity concern.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each performance test (dimension, physical properties, hole detection, powder residue, and biocompatibility). However, it implies that the tests were conducted according to established ASTM standards (D6319-19, D5151-19, D6124-06) and ISO standards (10993-5:2009, 10993-10:2021, 10993-23:2021, 10993-11:2017). These standards typically specify sampling plans and test methodologies.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are non-clinical performance and biocompatibility tests, which are typically conducted in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a "Nitrile Examination Glove," which is a physical product subject to objective performance testing against established standards, not a diagnostic or AI-driven device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, like medical imaging or clinical trials. The tests performed for this device are objective laboratory tests.
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:
This information is not applicable. This device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests relies on industry standards (ASTM and ISO) which define acceptable limits for physical properties, barrier integrity, and chemical residue. For biocompatibility, the ground truth is defined by the criteria established in the ISO 10993 series of standards.
8. The sample size for the training set:
This information is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established:
This information is not applicable due to the reasons stated in point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 16, 2023
Ecoglove Medical Manufacturing Company Limited % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, Illinois 60504
Re: K222813
Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 13, 2023 Received: February 22, 2023
Dear Manoj Zacharias:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Allan Gu
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K22813
Device Name
Nitrile Examination Gloves
Indications for Use (Describe)
Nitrile Examination Gloves is a disposable device intended for medical purpose that is 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)
X 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."
{3}------------------------------------------------
510(k) SUMMARY (K222813)
[AS REQUIRED BY 21CFR807.92]
SUBMITTER DETAILS I.
| 510(k) Owner's Name | : | ECOGLOVE MEDICAL MANUFACTURING COMPANY LIMITED |
|---|---|---|
| Address | : | A part of land plot No. 679, map No. 41, N4 Street, Bau Bang Hamlet, Lai Uyen Town, Bau Bang District, Binh Duong Province, Vietnam |
| Telephone | : | 02743599000 |
| Contact person | : | NGUYEN ANH TU |
| Designation | : | President |
| Contact Email | : | info@ecoglove.com |
| Correspondent Contact Details(US Agent Information) | : | Mr. Manoj Zacharias,Liberty Management Group Limited,75 Executive Drive Suite 114, Aurora, Illinois, 60504, US |
| Phone: +1 (630) 270 2921Fax: (815) 986-2632Email: manoj@libertymanagement.us | ||
| Date of Summary Prepared | : | 03-15-2023 |
II. DEVICE DETAILS
| Device Name | : | Nitrile Examination Gloves |
|---|---|---|
| Device Classification Name | : | Non-powdered patient examination glove |
| Regulation Number | : | 21 CFR 880.6250 |
| Class | : | I |
| Product Code | : | LZA |
III. PREDICATE DEVICE DETAILS
| Predicate Device Name | : ATM® Glove Powder free Nitrile Examination gloves |
|---|---|
| 510(k) Number | : K213016 |
| Regulation Number | : 21 CFR 880.6250 |
| Class | : I |
| Product Code | : LZA |
{4}------------------------------------------------
IV. DEVICE DESCRIPTION
Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color have Finger Texture, Ambidextrous, single-use, and are powderfree. The product is non-sterile.
V. INDICATIONS FOR USE
Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| SI.No | Features compared | Proposed Device | Predicate Device | Result |
|---|---|---|---|---|
| General Information | ||||
| 1. | 510(k) Number | K222813 | K213016 | - |
| 2. | Manufacturer | ECOGLOVE Medical ManufacturingCompany Limited | PHU DUC HUY Production TradingServices Corporation | - |
| 3. | Classification | I | I | - |
| 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| 5. | Product Code | LZA | LZA | Same |
| 6. | Indication For Use | Nitrile Examination Gloves is adisposable device intended formedical purpose that is worn onthe examiner's hand to preventcontamination between patientand examiner. | ATM® Glove Powder free NitrileExamination gloves are intendedfor medical purposes that is wornon the examiner's hands toprevent contamination betweenpatient and examiner. | Same |
| 7. | Material | Nitrile | Nitrile | Same |
| 8. | Color | Blue | Blue | Same |
| 9. | Texture | Finger Texture | Finger texture | Same |
| 10. | Ambidextrous | Yes | Yes | Same |
| 11. | Size | S, M, L, XL | S, M, L, XL | Same |
| 12. | OTC Use | Yes | Yes | Same |
| 13. | Reusability | Single use | Single use | Same |
| 14. | Sterility | Non- sterile | Non- sterile | Same |
| 15. | Dimensions | Length Min 230 mmWidth Min 95±10 mm (formedium size) | Length Min 230 mmWidth Min 95±10 mm (formedium size) | Same |
Table 1: General Comparison
{5}------------------------------------------------
| Sl.No | Features compared | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|---|
| 16. | Thickness | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same | |
| 17. | Physical Properties | Before AgingTensile Strength min 14 MPaUltimate Elongation Min 500%After AgingTensile Strength min 14 MPaUltimate Elongation Min 400% | Before AgingTensile Strength min 14 MPaUltimate Elongation Min 500%After AgingTensile Strength min 14 MPaUltimate Elongation Min 400% | Same | |
| 18. | Detection of Holes | Passes AQL 2.5 | Passes AQL 2.5 | Same | |
| 19. | Powder Free Residue | ≤2 mg/glove | ≤2 mg/glove | Same | |
| 20. | Biocompatibility Study | In vitro Cytotoxicity | Under the conditions of the study, cytotoxic. | Under the conditions of the study non- cytotoxic to L-929 cells. | DifferentRefer Note1 |
| Skin Sensitization | Under the condition of the study not a sensitizer | Under the condition of the study not a sensitizer | Same | ||
| Skin Irritation | Under the condition of the study not an irritant | Under the condition of the study not an irritant | Same | ||
| Acute systemic toxicity | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of the study, the device extracts do not pose a systemic toxicity concern | Same |
| Note1: Additional testing was performed to determine if this was a systemic toxicity concern. | ||||
|---|---|---|---|---|
| -- | -- | -- | ----------------------------------------------------------------------------------------------- | -- |
There are no significant differences between the two products and are similar in terms of intended use, materials, design, and manufacturing methods. Both devices met the performance standards.
VII. PERFORMANCE DATA
A. Non-Clinical Data
Performance Tests ਜ
Nitrile Examination Gloves are subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual
- . Dimension.
- Physical property .
- . Barrier property tests
-
Detection of Holes in Medical Gloves
-
- . Powder-Free Residue
{6}------------------------------------------------
| SINo. | Tests | Proposed Device actual Data | Acceptance Criteria | ||||
|---|---|---|---|---|---|---|---|
| Size | Length | Width | Size | Length | Width | ||
| 1. | DimensionLength, Width andThicknessASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication | S | 243 mm | 84.92 mm | S | 220mm min | 80 mm±10 |
| M | 242.30 mm | 95.30 mm | M | 95 mm ±10 | |||
| L | 243.30 mm | 110.53 mm | L | 230mm min | 110 mm ±10 | ||
| XL | 243.07 mm | 120.62 mm | XL | 120 mm ±10 | |||
| Thickness | Thickness | ||||||
| Size | Palm | Finger | Size | Palm | Finger | ||
| S | 0.086 mm | 0.115 mm | S | ||||
| M | 0.086 mm | 0.110 mm | M | 0.05 mm min | 0.05 mm min | ||
| L | 0.085 mm | 0.115 mm | L | ||||
| XL | 0.085 mm | 0.115 mm | XL | ||||
| Tensile strength | Tensile strength | ||||||
| Size | Before aging | After aging | Size | Before aging | After aging | ||
| 2. | Physical propertyTensile strengthand UltimateElongationASTM D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication | S | 17.44 MPa | 16.52 MPa | S | ||
| M | 17.60 MPa | 16.79 MPa | M | 14 MPa Min for allsizes | 14 MPa Min for allsizes | ||
| L | 16.75 MPa | 15.48 MPa | L | ||||
| XL | 16.03 MPa | 15.07 MPa | XL | ||||
| Ultimate elongation | Ultimate elongation | ||||||
| Size | Before aging | After aging | Size | Before aging | After aging | ||
| S | 519% | 511% | S | ||||
| M | 521% | 511% | M | 500% Min for allsizes | 400%Min for allsizes | ||
| L | 565% | 510% | L | ||||
| XL | 550% | 514% | XL | ||||
| 3. | Detection of Holesin Medical GlovesASTM D6319-19/ASTM D5151-19Standard TestMethod forDetection of Holesin Medical Gloves | Size | AQL 2.5 | Size | AQL 2.5 | ||
| S | S | ||||||
| M | M | ||||||
| L | L | ||||||
| XL | XL | ||||||
| 4. | Powder-FreeResidueASTM D6124-06(Reapproved 2017)Standard TestMethod for ResidualPowder on MedicalGloves | Size | Residual powder content | Size | Residual powder content | ||
| S | 0.02 Mg/glove | S | |||||
| M | 0.01 Mg/glove | M | ≤ 2 mg/Glove Max | ||||
| L | 0.01 Mg/glove | L | |||||
| XL | 0.01 Mg/glove | XL |
Table 2: Performance Testing Summary
{7}------------------------------------------------
2 Biocompatibility Tests
The Biocompatibility Tests performed are:
- . In vitro Cytotoxicity
- . Skin Sensitization
- Skin Irritation ●
- Acute Systemic Toxicity ●
Table 3: Biocompatibility Test Summary
| SLno | Title of Test | Purpose ofTest | ReferenceSource | AcceptanceCriteria | Result |
|---|---|---|---|---|---|
| 1 | In Vitro Cytotoxicity | To ensure thedevice isbiocompatible | ISO 10993-5:2009 | Non-cytotoxic | Fail |
| 2 | Skin Sensitization | ISO 10993-10:2021 | Non-sensitizer | Pass | |
| 3 | Skin Irritation | ISO 10993-23:2021 | Non-irritant | Pass | |
| 4 | Acute Systemic Toxicity | ISO 10993-11:2017 | Nontoxic | Pass |
3 Sterilization
A sterilization study was not conducted as Nitrile Examination Gloves is provided non-sterile.
C Clinical Test Data
The clinical study was not conducted as clinical data is not needed for Nitrile Examination Gloves.
VII. CONCLUSION
The conclusions drawn from the non-clinical tests demonstrate that the subject device, Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K213016.
§ 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.