(139 days)
ELAZ Nitrile Powder Free Examination Glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ELAZ Nitrile Powder Free Examination Glove is non-sterile, single use only, disposable, powder free examination glove. The glove is made of Acrylonitrile-butadiene rubber. The glove is designed to meets the specification of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the performance testing for the ELAZ Nitrile Powder Free Examination Glove, a Class I medical device. The information provided is for a traditional 510(k) submission, confirming substantial equivalence to a predicate device.
It's important to note that this is a medical glove, not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study designs for AI/software-based medical devices (like MRMC studies, expert ground truth adjudication, training/test set provenance for AI, etc.) are not applicable here. The performance evaluation focuses on physical properties, biocompatibility, and compliance with established ASTM and ISO standards for examination gloves.
Here's a breakdown of the provided information, framed within the context of a medical glove substantial equivalence submission:
1. Table of Acceptance Criteria and Reported Device Performance
The full table from the document (page 6-7) is replicated here, summarizing the acceptance criteria and the test results for the ELAZ Nitrile Powder Free Examination Glove.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19: Physical Dimensions Test (mm) | |||
| Length (mm) | S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230 | S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230 (All Pass) | |
| Width (mm) | S: 80±10, M: 95±10, L: 110±10, XL: 120±10 | S: 87-89, M: 99-101, L: 110-113, XL: 112-115 (All Pass) | |
| Finger Thickness (mm) | ≥ 0.05 | S ≥ 0.16, M ≥ 0.15, L ≥ 0.15, XL ≥ 0.13 (All Pass) | |
| Palm Thickness (mm) | ≥ 0.05 | S ≥ 0.11, M ≥ 0.11, L ≥ 0.11, XL ≥ 0.10 (All Pass) | |
| ASTM D5151-19 | Testing for Freedom from holes | AQL 2.5 | Gloves pass AQL 2.5 |
| ASTM D6124-17 | Determine the powder residue for powder free gloves | < 2 mg/glove | Average 0.43 mg/glove |
| ASTM D412, ASTM D573 | Testing for Physical property characteristics | Before Aging: Tensile strength ≥14 MPa, Ultimate Elongation ≥500% After Aging: Tensile strength ≥14 MPa, Ultimate Elongation ≥400% | Before Aging: Tensile strength ≥21 MPa, Ultimate Elongation ≥502% After Aging: Tensile strength ≥18 MPa, Ultimate Elongation ≥465% (All Pass) |
| ISO 10993-5 | Tests for In vitro cytotoxicity | Under the conditions of the study non-cytotoxic. | Under conditions of the study, it was considered "non-cytotoxic" at 25%, 12.5%, and 6.25% and demonstrate cytotoxicity at the 50% and 100% of the test item extract. (Meets non-cytotoxic criteria at relevant concentrations) |
| ISO 10993-10 | Evaluate the endpoint of irritant for biocompatibility | Under the conditions of the study, not an irritant. | Under the conditions of the study, not an irritant. |
| ISO 10993-10 | Evaluate the endpoint of sensitization for biocompatibility | Under the conditions of the study, not a sensitizer. | Under the conditions of the study, not a sensitizer. |
| ISO 10993-11 | Tests for systemic toxicity | Under the conditions of the 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 |
Regarding the other questions, which are highly relevant for AI/software medical devices but not for this traditional glove submission:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- For physical and performance tests, sample sizes are typically determined by the specific ASTM standard (e.g., AQL levels for freedom from holes, number of samples for tensile strength). These are standardized industry practices, not "data provenance" in the sense of patient data.
- The biocompatibility tests would involve animal models (for in vivo tests like irritation, sensitization, systemic toxicity) or cell cultures (for in vitro cytotoxicity). The document does not specify the exact sample sizes for each test, but they would follow the requirements of the respective ISO standards. This is not "patient data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for medical gloves is established by objective physical measurements and standardized biological tests according to the protocols defined in ASTM and ISO standards. There are no "experts" establishing ground truth in the sense of clinical image review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This applies to clinical interpretation studies, typically for AI/software devices.
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
- Not applicable. This relates to AI/software performance in diagnostic tasks and human-in-the-loop studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the performance of an AI algorithm. The device is a physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for medical gloves is defined by the validated and universally accepted specifications and test methods outlined in the ASTM and ISO standards (e.g., a hole is detected if water leaks, tensile strength is measured by a machine, biological response is quantified by established cytotoxicity assays). It is not clinical ground truth from patient outcomes or expert consensus.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of a physical medical device. Manufacturing processes are continually monitored for quality control, but this isn't machine learning training data.
9. How the ground truth for the training set was established
- Not applicable.
In summary, this document presents a standard premarket notification for a Class I medical glove. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are entirely based on established engineering and biomedical testing standards (ASTM and ISO), not on clinical or AI performance metrics. The device successfully met all specified acceptance criteria derived from these standards, demonstrating its substantial equivalence to legally marketed predicate devices.
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April 3, 2022
Protect Gloves Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd. 1435 Kanchanapisek Rd., Bang Khae Nuea Bangkok, Bang Khae 10160 Thailand
Re: K213604
Trade/Device Name: ELAZ Nitrile Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 21, 2022 Received: March 24, 2022
Dear Paweena U-Thainual:
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
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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,
Clarence W. Murray, III, PhD 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
Enclosure
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Indications for Use
510(k) Number (if known) K213604
Device Name
ELAZ Nitrile Powder Free Examination Glove
Indications for Use (Describe)
ELAZ Nitrile Powder Free Examination Glove is 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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K213604
510(k) Summary
| 1. | General Information | |
|---|---|---|
| Applicant/Submitter: | Protect Gloves Company Limited | |
| Address: | 60/138 Moo 3 Mabyangporn Pluakdang | |
| Rayong, 21140 THAILAND | ||
| Tel: +66-2-384-3049 | ||
| Email: nathaphon@me.com | ||
| Contact Person: | Paweena U-Thainual, PhD | |
| Address: | MDR Solutions, Co., Ltd. | |
| 1435 Kanchanapisek Rd., Bang Khae Nuea | ||
| Bang Khae, Bangkok 10160 THAILAND | ||
| Email: paweena@mdrsolutions.co.th | ||
| Preparation Date: | November 8, 2021 | |
2. Device Name and Code
| Device Trade Name: | ELAZ Nitrile Powder Free Examination Glove |
|---|---|
| Common Name: | Nitrile Patient Examination Glove |
| Classification Name: | Non-Powdered Patient Examination Glove |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 882.6250 |
| Classification: | I |
| Review Panel: | General Hospital |
Predicate Device 3.
Provided below is the legally marketed predicate device.
Table 1 Primary Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Tangshan LanhaiMedical Supplies Co.,Ltd. | Disposable NitrileExamination Gloves (Powderfree, Purple-Blue, Blue) | K210898 |
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4. Device Description
ELAZ Nitrile Powder Free Examination Glove is non-sterile, single use only, disposable, powder free examination glove. The glove is made of Acrylonitrile-butadiene rubber. The glove is designed to meets the specification of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Indications / Intended Use 5.
ELAZ Nitrile Powder Free Examination Glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Technological Characteristics Comparison: 6.
ELAZ Nitrile Powder Free Examination Glove is compared to the legally marketed predicate device.
| Proposed Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Manufacturer | Protect Gloves Co., Ltd. | Tangshan Lanhai Medical Supplies Co., Ltd. | N/A |
| Trade Name | ELAZ Nitrile Powder Free Examination Glove | Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) | N/A |
| 510(k) Number | K213604 | K210898 | N/A |
| Classification | Class I | Class I | YES |
| Product Code | LZA | LZA | YES |
| Regulation Number | 880.6250 | 880.6250 | YES |
| Intended Use/ Indications For use | ELAZ Nitrile Powder Free Examination Glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner | The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | YES |
| Powdered Free | Yes | Yes | Yes |
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| Device Dimensions Comparison | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Size | S, M, L, XL | XS, S, M, L, XL | YES* | ||||||||
| Color | Blue | Purple-Blue, Blue | YES | ||||||||
| Sterility | Non-Sterile | Non-Sterile | YES | ||||||||
| S | M | L | XL | XS | S | M | L | XL | YES | ||
| Length (mm) | ≥ 220 | ≥ 230 | ≥ 230 | ≥ 230 | ≥ 220 | ≥ 220 | ≥ 230 | ≥ 230 | ≥ 230 | ||
| Width (mm) | S | M | L | XL | XS | S | M | L | XL | YES | |
| 80±10 | 95±10 | 110±10 | 120±10 | 70±10 | 80±10 | 95±10 | 110±10 | 120±10 | |||
| FingerThickness(mm) | ≥ 0.05 | ≥ 0.05 | YES | ||||||||
| PalmThickness(mm) | ≥ 0.05 | ≥ 0.05 | YES | ||||||||
| Performance and Physical Comparison | |||||||||||
| Before Aging | After Aging | Before Aging | After Aging | ||||||||
| TensileStrength(MPa) | ≥ 14 | ≥ 14 | ≥ 14 | ≥ 14 | YES | ||||||
| UltimateElongation(%) | Before Aging | After Aging | Before Aging | After Aging | YES | ||||||
| ≥ 500 | ≥ 400 | ≥ 500 | ≥ 400 | ||||||||
| Single Use | Yes | Yes | YES | ||||||||
| Be free from holes when tested in | Be free from holes when tested in | ||||||||||
| Freedomfrom hole | accordance with ASTM D5151AQL 2.5 | accordance with ASTM D5151AQL 2.5 | YES | ||||||||
| PowderContent | Powder residue ≤ 2.0 mg | Powder residue ≤ 2.0 mg | YES | ||||||||
| Comply withASTM D6319 | Yes | Yes | YES | ||||||||
| MaterialUsed | Nitrile | Nitrile | YES | ||||||||
| Shelf life | 3 years | N/A | N/A | ||||||||
| Safety Comparison - Biocompatibility Test | |||||||||||
| Irritation | Under the conditions of the study,not an irritant | Under the conditions of the study, notan irritant | YES | ||||||||
| Sensitization | Under conditions of the study, not asensitizer | Under conditions of the study, not asensitizer | YES | ||||||||
| Cytotoxicity | Under conditions of the study, itwas considered as "non-cytotoxic"at 25%, 12.5%, and 6.25% anddemonstrate cytotoxicity at the 50%and 100% of the test item extract. | N/A | N/A | ||||||||
| AcuteSystemicToxicity | Under the conditions of the study,there was no evidence of systemictoxicity from the extract | YES |
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- When compared to the same size, the dimensions, and physical design are identical.
Performance Data 7.
Non-clinical tests:
Bench tests were conducted according to the FDA-recognized consensus standard, to verify that the proposed device met all design specifications. The proposed device complies with the following standards:
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical । Application.
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. -
- -ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves.
Biocompatibility tests were conducted according to the FDA-recognized consensus standard, to verify the safety of the device.
- ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for In vitro cytotoxicity.
- ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization.
- -ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | PhysicalDimensionsTest (mm) | Length (mm) | Length (mm) |
| S ≥ 220 | S ≥ 220 | ||
| M ≥ 230 | M ≥ 230 | ||
| L ≥ 230 | L ≥ 230 | ||
| XL ≥ 230 | XL ≥ 230 | ||
| Width (mm) | Width (mm) | ||
| S: 80±10 | S: 87-89 | ||
| M: 95±10 | M: 99-101 | ||
| L: 110±10 | L: 110-113 | ||
| XL: 120±10 | XL: 112-115 | ||
| Finger Thickness (mm) | Finger Thickness (mm) | ||
| ≥0.05 | S ≥ 0.16 | ||
| M ≥ 0.15 | |||
| L ≥ 0.15 | |||
| XL ≥ 0.13 | |||
| Palm Thickness (mm) | Palm Thickness (mm) | ||
| >0.05 | S > 0.11 |
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| M ≥ 0.11L ≥ 0.11XL ≥ 0.10 | |||
|---|---|---|---|
| ASTM D5151-19 | Testing for Freedomfrom holes | AQL 2.5 | Gloves pass AQL 2.5 |
| ASTM D6124-17 | Determine thepowder residue forpowder free gloves | < 2 mg/glove | Average 0.43 mg/glove |
| ASTM D412ASTM D573 | Testing for Physicalpropertycharacteristics | Before AgingTensile strength ≥14 MPaUltimate Elongation≥500%After AgingTensile strength ≥14 MPaUltimate Elongation≥400% | Before AgingTensile strength ≥21 MPaUltimate Elongation≥502%After AgingTensile strength ≥18 MPaUltimate Elongation≥465% |
| ISO 10993-5 | Tests for In vitrocytotoxicity | Under the conditions ofthe study non-cytotoxic. | Under conditions of thestudy, it was considered"non-cytotoxic" at 25%,12.5%, and 6.25% anddemonstrate cytotoxicityat the 50% and 100% ofthe test item extract. |
| ISO 10993-10 | Evaluate theendpoint ofirritant forbiocompatibility | Under the conditions ofthe study, not an irritant. | Under the conditions ofthe study, not an irritant. |
| ISO 10993-10 | Evaluate theendpoint ofsensitization forbiocompatibility | Under the conditions ofthe study, not a sensitizer. | Under the conditions ofthe study, not a sensitizer. |
| ISO 10993-11 | Tests for systemictoxicity | Under the conditions ofthe study, the deviceextracts do not pose asystemic toxicityconcern | Under the conditions ofthe study, the deviceextracts do not pose asystemic toxicityconcern |
Conclusions 8.
The conclusions drawn from the non-clinical tests demonstrate that the subject device, ELAZ Nitrile Powder Free Examination Glove, is as safe, as effective, and performs as well as or better than the legally marketed 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.