(139 days)
Not Found
No
The device is a disposable examination glove, and the description focuses on material properties, physical performance, and biocompatibility testing, with no mention of AI or ML.
No.
The device's intended use is to prevent contamination, which is a protective measure rather than a therapeutic one (treating or alleviating a disease/condition).
No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner. Its description and performance studies focus on physical properties and biocompatibility, not on diagnosing medical conditions.
No
The device is a physical examination glove made of nitrile rubber, not a software application. The description focuses on material properties, physical dimensions, and biocompatibility testing, which are characteristic of a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and material of the glove, designed for protection and examination, not for analyzing samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing any kind of diagnostic result.
- Performance Studies: The performance studies described are related to the physical integrity, safety, and biocompatibility of the glove, not its ability to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not perform any of those functions.
N/A
Intended Use / Indications for Use
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.
Product codes
LZA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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 tests were conducted according to FDA-recognized consensus 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 FDA-recognized consensus standards:
- 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.
Key results from the tests include:
- Physical Dimensions Test (ASTM D6319-19): Met length and width specifications for sizes S, M, L, XL. Finger thickness for S, M, L, XL ranged from ≥ 0.13 to ≥ 0.16 mm (acceptance ≥ 0.05 mm). Palm thickness for S, M, L, XL ranged from ≥ 0.10 to > 0.11 mm (acceptance > 0.05 mm).
- Freedom from holes (ASTM D5151-19): Gloves passed AQL 2.5.
- Powder Content (ASTM D6124-17): Average powder residue was 0.43 mg/glove (acceptance
§ 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
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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
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,
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 Lanhai | ||
| Medical Supplies Co., | ||
| Ltd. | Disposable Nitrile | |
| Examination Gloves (Powder | ||
| free, 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 |
Page 2 of 5
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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 | |||
| Finger | |||||||||||
| Thickness | |||||||||||
| (mm) | ≥ 0.05 | ≥ 0.05 | YES | ||||||||
| Palm | |||||||||||
| Thickness | |||||||||||
| (mm) | ≥ 0.05 | ≥ 0.05 | YES | ||||||||
| Performance and Physical Comparison | |||||||||||
| Before Aging | After Aging | Before Aging | After Aging | ||||||||
| Tensile | |||||||||||
| Strength | |||||||||||
| (MPa) | ≥ 14 | ≥ 14 | ≥ 14 | ≥ 14 | YES | ||||||
| Ultimate | |||||||||||
| Elongation | |||||||||||
| (%) | 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 | ||||||||||
| Freedom | |||||||||||
| from hole | accordance with ASTM D5151 | ||||||||||
| AQL 2.5 | accordance with ASTM D5151 | ||||||||||
| AQL 2.5 | YES | ||||||||||
| Powder | |||||||||||
| Content | Powder residue ≤ 2.0 mg | Powder residue ≤ 2.0 mg | YES | ||||||||
| Comply with | |||||||||||
| ASTM D6319 | Yes | Yes | YES | ||||||||
| Material | |||||||||||
| Used | 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, not | ||||||||||
| an irritant | YES | ||||||||||
| Sensitization | Under conditions of the study, not a | ||||||||||
| sensitizer | Under conditions of the study, not a | ||||||||||
| sensitizer | YES | ||||||||||
| Cytotoxicity | Under conditions of the study, it | ||||||||||
| was considered as "non-cytotoxic" | |||||||||||
| at 25%, 12.5%, and 6.25% and | |||||||||||
| demonstrate cytotoxicity at the 50% | |||||||||||
| and 100% of the test item extract. | N/A | N/A | |||||||||
| Acute | |||||||||||
| Systemic | |||||||||||
| Toxicity | Under the conditions of the study, | ||||||||||
| there was no evidence of systemic | |||||||||||
| toxicity from the extract | YES |
6
- 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.
| Test
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | Physical | ||
| Dimensions | |||
| Test (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 |
7
| | | | M ≥ 0.11
L ≥ 0.11
XL ≥ 0.10 |
|------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |