(108 days)
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Premarket Notification for LYDUS Nitrile Examination Gloves, Powder Free. It aims to demonstrate that this device is substantially equivalent to a predicate device already legally marketed. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to show the new device performs as safely and effectively as the predicate device, adhering to relevant standards.
Here's the information extracted from the provided text, formatted to address your questions. Please note that this document does not pertain to AI/ML medical devices, so many of your questions related to multi-reader multi-case studies, expert adjudication, or training/test sets for algorithms are not applicable and will be marked as such.
Device Performance Study Details
The study focuses on demonstrating the substantial equivalence of the LYDUS Nitrile Examination Gloves, Powder Free to a legally marketed predicate device (K192333, "Blue Nitrile Examination Gloves Powder Free"). This is achieved through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Device: LYDUS Nitrile Examination Gloves, Powder Free
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Physical Dimensions (ASMT D6319-19) | To determine the width, length, and thickness of the gloves. | Width: 91 mm (Mean) (for medium size)Length: 241 mm (Mean) (for medium size)Thickness: Finger - 0.13 mm (Mean), Palm - 0.09 mm (Mean) | Passed (Specific measurements not detailed in "Result" column, but stated as "Passed") |
| Physical Requirements (ASMT D6319-19) | To determine the tensile strength and ultimate elongation before and after acceleration aging. | Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 601 (Mean)After Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 571 (Mean) | Passed (Specific measurements not detailed in "Result" column, but stated as "Passed") |
| Freedom from Holes (ASTM D6319-19 / ASTM D5151-11) | To determine the holes in the gloves (water tight - 1000 ml). | AQL 2.5 | Passed |
| Residual Powder (ASMT D6319-19 / ASTM D6124-11) | To determine the residual powder in the gloves. | < 2.0 mg/glove | 0.80 mg/glove (Meets criteria) |
| Skin Irritation (ISO 10993-10) | To determine the potential of the material to produce skin irritation in rabbits. | Under the condition of study not an irritant. | Under the condition of study not an irritant. |
| Skin Sensitization (ISO 10993-10) | To determine the skin sensitization potential of the material in guinea pigs. | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| In Vitro Cytotoxicity (ISO 10993-5) | To evaluate the in vitro cytotoxic potential of the test item (inner and outer surface) extracts in L-929 mouse fibroblasts cells using elution method. | Under the conditions of study non-cytotoxic. | Exhibit cytotoxic reactivity at 100% extract concentration (Grade 4 with neat extract). Non-cytotoxic reactivity at 50%, 25%, 12.5% and 6.25% extract concentration. (While 100% showed reactivity, lower concentrations were non-cytotoxic, which, according to the comparison table on page 6, is considered "Similar" to the predicate, implying acceptability). |
| Acute Systemic Toxicity (ISO 10993-11:2017) | The test item was evaluated for acute systemic toxicity in Swiss Albino Mice. | Under the conditions of the study no systemic toxicity. | Under the conditions of the study no systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical dimensions or holes). However, the tests are conducted according to the referenced ASTM and ISO standards, which would stipulate appropriate sample sizes for product quality control.
- Data Provenance: The manufacturer is Nathan Trading Co., Ltd. located in Thailand. The testing was non-clinical laboratory testing, performed to international standards. It is retrospective in the sense that it's a verification of product attributes, not a clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a non-clinical performance test for a medical device (gloves), not an AI/ML diagnostic device requiring expert interpretation of medical images. The "ground truth" is defined by the established physical, chemical, and biological performance standards (ASTM and ISO).
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is non-clinical product testing against defined standards, not a diagnostic task requiring human adjudication of ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for AI/ML diagnostic tools that impact human reader performance. It is not applicable to the performance testing of medical gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This document describes the performance of a physical medical device (gloves), not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by well-defined, internationally recognized consensus standards for medical gloves:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-11 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-11 Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device; there is no "training set" in the context of machine learning. The manufacturing process of the gloves functions as the "training" (i.e., production under controlled conditions to meet specifications).
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" for glove manufacturing is adherence to material specifications and manufacturing protocols designed to produce a product meeting the performance standards mentioned in point 7.
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February 22, 2021
Nathan Trading Co., Ltd % Abdel Halim, PharmD, MSc, PhD, DABCC President Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831
Re: K203191
Trade/Device Name: LYDUS Nitrile Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA
Dear Abdel Halim:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 12, 2021. Specifically, FDA is updating this SE Letter as an administrative correct an incorrect contact name and an incorrect 510(k) number and contact name in the header.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ryan Ortega, OHT4: Office of Surgical and Infection Control Devices, 240-402-2303, Ryan.Ortega@fda.hhs.gov.
Sincerely,
Ryan Ortega -S
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
February 12, 2021
Nathan Trading Co., Ltd % Abdel B. Halim, PharmD, MSc, PhD, DABCC Responsible Third-Party Official Global Quality and Regulatory Services 10 Scenic Way Monroe, NJ 08831
Re: K203191
Trade/Device Name: LYDUS Nitrile Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: January 26, 2021 Received: January 28, 2021
Dear Rafael Aguila:
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.
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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) 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 (OS) 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.
Ryan Ortega -S
For CAPT. Elizabeth Claverie, M.S. 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
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Indications for Use
510(k) Number (if known)
Device Name
LYDUS Nitrile Examination Gloves, Powder Free
Indications for Use (Describe)
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers 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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Image /page/4/Picture/0 description: The image is a circular logo for Nathan Trading Company Limited, or NTC. The logo has a green border with the word "NATHAN" at the top and "TRADING COMPANY LIMITED" at the bottom. There are two stars on either side of the word "NATHAN". In the center of the logo is the acronym "NTC" in bold, black letters.
NATHAN TRADING CO., LTD 58 Moo 12 Palan Sub-District, Nathan District, Ubon Ratchathani 34170 Thailand E-mail: csaiyasak@nathantrad.comTel.: +66818789953 Web: www.nathantrad.com
510(K) Summary K203191
LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE
Preparation Date: February 9, 2021
1. SUBMITTER
Company Name: Nathan Trading Co., Ltd. Company Address: 58 Moo 12 Palan Sub-District, Nathan District, Ubon Ratchathani 34170 Thailand
Contact Person: Prof. Dr. Chansamone Saiyasak Telephone Number: +66-81-878-9953 Email: csaiyasak@nathantrad.com
2. NAME OF THE DEVICE
Trade Name / Proprietary Name: LYDUS Nitrile Examination Gloves, Powder Free Device Name: LYDUS Nitrile Examination Gloves, Powder Free Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA
3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Predicate Device: K192333 Device Name: Blue Nitrile Examination Gloves Powder Free Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital
4. DEVICE DESCRIPTION
The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
5. INTENDED USE OF THE DEVICE
L YDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
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6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES
| DEVICE PERFORMANCE | |||||
|---|---|---|---|---|---|
| CHARACTERISTICS | PREDICATE | SUBJECT | REMARKS | ||
| 510(k) Number | K192333 | K203191 | - | ||
| Device Name | Blue NitrileExamination GlovesPowder Free | Nitrile ExaminationGloves, Powder Free | - | ||
| Product Code | LZA | LZA | Same | ||
| Intended Use | JR MEDIC Blue NitrileExamination GlovesPowder Free isdisposable devicesintended for medicalpurpose that are wornon the examiner'shand or fingers toprevent contaminationbetween patient andexaminer. The device isfor over the-counter use. | LYDUS NitrileExamination Gloves,Powder Free is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor fingers to preventcontamination betweenpatient and examiner. | Same | ||
| Materials of Use(ASTMD6910/D6910M-19) | Nitrile compound | Nitrile compound | Same | ||
| Color | Blue | Blue | Same | ||
| Texture | Finger Textured | Finger Textured | Same | ||
| Size(ASTM D6319-19) | Small, Medium, Large,Extra Large | Small, Medium, Large,Extra Large | Same | ||
| Sterilization | Non-sterile | Non-sterile | Same | ||
| Usage | Single usage | Single usage | Same | ||
| Dimensions(ASTM D6319-19) | Length Min. 230 minWidth Min 95+/-10 mm(for medium size) | Length Min. 230 minWidth Min 95+/-10 mm(for medium size) | Same | ||
| Physical Properties(ASTM D6319-19) | Before AgingTensile StrengthMin 14 MpaUltimate ElongationMin 500% | Before AgingTensile StrengthMin 14 MpaUltimate ElongationMin 500% | Same | ||
| After AgingTensile StrengthMin 14 MpaUltimate ElongationMin 400% | After AgingTensile StrengthMin 14 MpaUltimate ElongationMin 400% | ||||
| Thickness(ASTM D6319-19) | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same | ||
| Powder Free(ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same | ||
| Freedom from Holes(Water Tight -1000 ml) -ASTM D6319-19 (CrossReference D5151) | Passed | Passed | Same | ||
| Biocompatibility -SKIN SENSITIZATION -ISO 10993-10: 2010 (E) | Under the conditions ofstudy not an irritant | Under the conditions ofstudy not an irritant | Same | ||
| Biocompatibility -SKIN IRRITATION - ISO10993-10: 2010 (E) | Under the conditions ofthe study not a sensitizer | Under the conditions ofthe study not asensitizer | Same | ||
| Biocompatibility -IN VITROCYTOTOXICITY - ISO10993-5: 2009(E) | Under the conditions ofthe cytotoxicity study,additional acutesystemic toxicity testingresults showed nosystemic toxicityconcern. | Exhibit cytotoxicreactivity at 100%extract concentration(Grade 4 with neatextract).Non-cytotoxicreactivity at 50%, 25%,12.5% and 6.25%extract concentration. | Similar | ||
| Biocompatibility -ACUTE SYSTEMICTOXICITY - ISO 10993-11: 2017(E) | Under the conditions ofthe study no systemictoxicity | No systemic toxicityunder the experimentalconditions employed | Similar | ||
| Manufacturer(s) | JR Engineering &Medical Technologies(M) SDN.BHD.,Malaysia | Nathan Trading Co.,Ltd., Thailand |
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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. Both devices meet the ASTM standard D6319-19.
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7. NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalDimensions Test | To determine thewidth, length, andthickness of thegloves | Width:91 mm (Mean)(for medium size)Length:241 mm (Mean)(for medium size)Thickness: Finger -0.13 mm (Mean) Palm -0.09 mm (Mean) | Passed |
| ASMT D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication - PhysicalRequirements Test | To determine thetensile strengthand ultimateelongation beforeand afteracceleration aging | Before Acceleration Aging: TensileStrength (MPa): 34 (Mean) UltimateElongation (%): 601 (Mean)After Acceleration Aging:Tensile Strength (MPa): 34 (Mean)Ultimate Elongation (%): 571 | Passed |
| ASTM D6319-19(ASTM D5151-11)Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in thegloves | (Mean)AQL 2.5 | Passed |
| ASMT D6319-19(ASTM D6124-11)Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powderin the gloves | < 2.0 mg/glove | 0.80mg/glove |
BIO-COMPATIBILITY DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO 10993-10 Biological evaluationof medical devices - Part 10: Testsfor skin irritation and skinsensitization | To determine the potential of thematerial under test to produceskin irritation in rabbits | Under thecondition ofstudy not anirritant | Under the condition ofstudy not an irritant |
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| ISO 10993-10 Biological evaluationof medical devices - Part 10: Testsfor skin irritation and skinsensitization | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inguinea pigs. | Under theconditions of thestudy not asensitizer. | Under the conditions ofthe study not asensitizer. |
|---|---|---|---|
| ISO 10993-5 Biological evaluationof medical devices - Part 5: Testsfor in vitro cytotoxicity | To evaluate the in vitro cytotoxicpotential of the test item (bothinner and outer surface) Extractsin L-929 mouse fibroblasts cellsusing elution method | Under theconditions ofstudy noncytotoxic | Exhibit cytotoxicreactivity at 100%extract concentration(Grade 4 with neatextract).Non-cytotoxicreactivity at 50%, 25%,12.5% and 6.25%extract concentration. |
| ISO 10993-11:2017 Biologicalevaluation of medical devices-Part 11: Tests for acute systemictoxicity | The test item was evaluated foracute systemic toxicity in SwissAlbino Mice | Under theconditions of thestudy no systemictoxicity | Under the conditions ofthe study no systemictoxicity |
8. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the LYDUS Nitrile Examination Gloves, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192333
§ 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.