(178 days)
Not Found
No
The device description and performance studies focus on the physical and barrier properties of examination gloves, with no mention of AI or ML technology.
No
Explanation: The device is an examination glove intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device, Nitrile Examination Gloves, is described as a disposable device worn on the hand to prevent contamination. Its intended use and performance studies focus on physical and barrier properties, not on diagnosing any condition or disease.
No
The device description clearly states it is a physical product (gloves) made from acrylonitrile-butadiene copolymer dispersion, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties and materials of the gloves, not on any diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
- Regulatory Classification: The device is classified as Class I with product code LZA (21CFR 880.6250), which is for "Gloves, Examination, Patient." This classification is for general medical devices, not specifically for IVDs.
- Performance Studies: The performance studies focus on physical properties, barrier function, and biocompatibility, which are relevant to a barrier device, not an IVD.
IVD devices are designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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)
Non-Clinical Data: Performance Tests of Dimension, Physical Property, Barrier Property (Detection of Holes), and Powder-Free Residue were conducted following ASTM D6319-19 and ASTM D5151-19. Biocompatibility Tests performed were In vitro Cytotoxicity, Skin Sensitization, Skin Irritation, and Acute Systemic Toxicity following ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, and ISO 10993-11:2017. The In Vitro Cytotoxicity test resulted in "Fail" but noted as non-cytotoxic to L-929 cells. Other biocompatibility tests passed. Sterilization study was not conducted as the device is non-sterile. No clinical study was conducted as clinical data is not needed.
The key results showed that the proposed device performed similarly to the predicate device in terms of all physical properties, barrier properties, and most biocompatibility aspects, meeting the specified acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Dimension: Length Min 230 mm (220mm min for S), Width Min 95±10 mm (80-120mm ±10 for different sizes). Actual data provided.
- Thickness: Palm min 0.05 mm, Finger min 0.05 mm. Actual data provided.
- Tensile Strength: Before Aging min 14 MPa, After Aging min 14 MPa. Actual data provided.
- Ultimate Elongation: Before Aging Min 500%, After Aging Min 400%. Actual data provided.
- Detection of Holes: Passes AQL 2.5.
- Powder-Free Residue: ≤2 mg/glove. Actual data provided (0.01-0.02 Mg/glove).
Biocompatibility:
- In Vitro Cytotoxicity: Acceptance Criteria: Non-cytotoxic, Result: Fail (Note: Under the conditions of the study non-cytotoxic to L-929 cells.)
- Skin Sensitization: Acceptance Criteria: Non-sensitizer, Result: Pass
- Skin Irritation: Acceptance Criteria: Non-irritant, Result: Pass
- Acute Systemic Toxicity: Acceptance Criteria: Nontoxic, Result: Pass
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.
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
§ 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.
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)
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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 2921 | ||
| Fax: (815) 986-2632 | ||
| Email: 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 Manufacturing | ||
| Company Limited | PHU DUC HUY Production Trading | |||
| Services 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 a | ||
| disposable device intended for | ||||
| medical purpose that is worn on | ||||
| the examiner's hand to prevent | ||||
| contamination between patient | ||||
| and examiner. | ATM® Glove Powder free Nitrile | |||
| Examination gloves are intended | ||||
| for medical purposes that is worn | ||||
| on the examiner's hands to | ||||
| prevent contamination between | ||||
| patient 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 mm | ||
| Width Min 95±10 mm (for | ||||
| medium size) | Length Min 230 mm | |||
| Width Min 95±10 mm (for | ||||
| medium size) | Same |
Table 1: General Comparison
5
| Sl.
| No | Features compared | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|---|
| 16. | Thickness | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Palm min 0.05 mm | ||||
| Finger min 0.05 mm | Same | ||||
| 17. | Physical Properties | 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% | |||||
| After Aging | |||||
| Tensile Strength min 14 MPa | |||||
| Ultimate 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. | Different |
| Refer 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
| SI
| No. | Tests | Proposed Device actual Data | Acceptance Criteria | ||||
|---|---|---|---|---|---|---|---|
| Size | Length | Width | Size | Length | Width | ||
| 1. | Dimension | ||||||
| Length, Width and | |||||||
| Thickness | |||||||
| ASTM D6319-19 | |||||||
| Standard | |||||||
| Specification for | |||||||
| Nitrile Examination | |||||||
| Gloves for Medical | |||||||
| Application | 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 property | ||||||
| Tensile strength | |||||||
| and Ultimate | |||||||
| Elongation | |||||||
| ASTM D6319-19 | |||||||
| Standard | |||||||
| Specification for | |||||||
| Nitrile Examination | |||||||
| Gloves for Medical | |||||||
| Application | S | 17.44 MPa | 16.52 MPa | S | |||
| M | 17.60 MPa | 16.79 MPa | M | 14 MPa Min for all | |||
| sizes | 14 MPa Min for all | ||||||
| sizes | |||||||
| 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 all | |||
| sizes | 400%Min for all | ||||||
| sizes | |||||||
| L | 565% | 510% | L | ||||
| XL | 550% | 514% | XL | ||||
| 3. | Detection of Holes | ||||||
| in Medical Gloves | |||||||
| ASTM D6319-19 | |||||||
| /ASTM D5151-19 | |||||||
| Standard Test | |||||||
| Method for | |||||||
| Detection of Holes | |||||||
| in Medical Gloves | Size | AQL 2.5 | Size | AQL 2.5 | |||
| S | S | ||||||
| M | M | ||||||
| L | L | ||||||
| XL | XL | ||||||
| 4. | Powder-Free | ||||||
| Residue | |||||||
| ASTM D6124-06 | |||||||
| (Reapproved 2017) | |||||||
| Standard Test | |||||||
| Method for Residual | |||||||
| Powder on Medical | |||||||
| Gloves | 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
| SL
no | Title of Test | Purpose of
Test | Reference
Source | Acceptance
Criteria | Result |
|----------|-------------------------|---------------------------------------------|---------------------|------------------------|--------|
| 1 | In Vitro Cytotoxicity | To ensure the
device is
biocompatible | 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.