Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary contains no mention of AI or ML.

Therapeutic

No.
The device (examination gloves) is intended to prevent contamination between the patient and the examiner, which is a barrier function, not a therapeutic action to treat or cure a disease or medical condition.

Diagnostic

No

Explanation: The device is an examination glove, used to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical product (nitrile gloves) and not software. The description focuses on material properties and physical performance tests.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical properties and materials of the glove, consistent with a medical device used for protection.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Regulatory Classification: The device is classified as Class I with product code LZA (21CFR 880.6250), which is for "Glove, Examination, Patient." This classification is for medical gloves, not IVD devices.

In summary, the purpose and characteristics of this device clearly align with a medical glove used for barrier protection, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

EONS Nitrile Examination Gloves Powder Free 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

EONS Nitrile Examination Gloves Powder Free 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 having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Performance Tests:

Dimension: Length, Width, and Thickness (ASTM D6319-19, ASTM D3767-03). All sizes (S, M, L, XL) passed.
Physical property: Tensile strength and Ultimate Elongation (ASTM D6319-19, ASTM D412-16). All sizes passed for both before and after aging.
Barrier property tests: Detection of Holes in Medical Gloves (ASTM D6319-19, ASTM D5151-06). Passed for all sizes with AQL 2.5.
Powder Free Residue: Residual Powder on Medical Gloves (ASTM D6124-06). Passed for all sizes with content

Regulation Number and Section

§ 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.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 19, 2022

Eons Gloves (Thailand) Co., Ltd % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive Suite 114 Aurora, Illinois 60504

Re: K213286

Trade/Device Name: Eons 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 Dated: January 24, 2022 Received: January 31, 2022

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

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213286

Device Name

EONS Nitrile Examination Gloves Powder Free

Indications for Use (Describe)

EONS Nitrile Examination Gloves Powder Free 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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Image /page/3/Picture/0 description: The image shows a logo for EONS GLOVES. The logo is in the shape of a silver shield with a blue ribbon across the middle. The words "EONS GLOVES" are written in white on the blue ribbon. There is a plus sign in the center of the shield above the ribbon.

EONS GLOVES (THAILAND) CO., LTD

486/14 Moo 9 Nai Klong bang Pla Kot, Phra Samut Chedi District, Samut Prakan Province 10290 Thailand Email: eonsglovesthailand@gmail.com Tel: 02-464-0842 HP: +6681-934-3579 www.eonsgloves.com

510(k) SUMMARY (K213286)

[AS REQUIRED BY 21CFR807.92]

SUBMITTER I.

510(k) Owner's Name	:	EONS GLOVES (THAILAND) CO., LTD
Address	:	486/14 Moo 9 Nai Klong Bang Pla Kot, Phra, Samut Chedi
SamutPrakan,10290Thailand
Telephone	:	+66 958638585
Contact person	:	Ms. Gliaophan Supharkarn
Designation	:	Vice President
Contact Number	:	+66 958638585
Contact Email	:	toutah.13@gmail.com
Date of Summary Prepared	:	24.01.2022

II. DEVICE

Device Name	:	EONS Nitrile Examination Gloves Powder Free
Device Common Name	:	Nitrile Examination Gloves Powder Free
Device Classification name	:	Non-powdered patient examination glove
Regulation Number	:	21 CFR 880.6250
Class	:	I
Product Code	:	LZA

III. PREDICATE DEVICE

Predicate Device Name	: JR MEDIC Blue Nitrile Examination Gloves Powder Free
510(k) Number	: K192333
Regulation Number	: 21 CFR 880.6250
Class	: I
Product Code	: LZA

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IV. DEVICE DESCRIPTION

EONS Nitrile Examination Gloves Powder Free 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 having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

V. INTENDED USE

EONS Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose 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	K213286	K192333	-
2.	Manufacturer	EONS GLOVES (Thailand) CO.,
LTD	JR Engineering & Medical
Technologies (M) SDN.BHD	-
3.	Classification	I	I	Same
4.	Regulation number	21 CFR 880.6250	21 CFR 880.6250	Same
5.	Product Code	LZA	LZA	Same
6.	Indication For Use	EONS Nitrile Examination Gloves
Powder Free is a disposable device
intended for medical purpose that
is worn on the examiner's hand to
prevent contamination between
patient and examiner.	JR MEDIC Blue Nitrile
Examination Gloves Powder Free
is disposable devices intended for
medical purpose that are worn on
the examiner's hand 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	Data Not available	-
11.	Size	S, M, L, XL	XS, S, M, L, XL	Similar1
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 m
Width Min 95±10
Mm (for medium size)	Length Min 230 m
Width Min 95±10
Mm (for medium size)	Same
16.	Thickness	Palm min 0.05 mm
Finger min 0.05 mm	Palm min 0.05 mm
Finger min 0.05 mm	Same

Table 1: General Comparison

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| Sl.

No	Features compared	Proposed Device	Predicate Device	Result
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 1.5	Similar²
19.	Powder Free Residue	≤2 mg/glove	≤2 mg/glove	Same
20.	Biocompatibility Study	In vitro Cytotoxicity	Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern	Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern	Same
		Skin Sensitization	Under the conditions of the study not a sensitizer	Under the conditions of the study not a sensitizer	Same
		Skin Irritation	Under the condition of study not an irritant	Under the condition of study not an irritant	Same
		Acute systemic toxicity	Under the condition of study, the device extracts do not pose a systemic toxicity.	Under the condition of study, the device extracts do not pose a systemic toxicity.	Same
		Material mediated pyrogenicity	Under the conditions of the study, the device demonstrate a non-pyrogenic response.	Under the conditions of the study, the device did not demonstrate a material mediated Pyrogenicity response.	Same

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices met the performance standards.

VII. PERFORMANCE DATA

A. Non- Clinical Data

Performance Tests

EONS Nitrile Examination Gloves Powder Free is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use:

· Dimension
Physical property
· Barrier property tests
- Detection of Holes in Medical Gloves
Powder Free Residue

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| | Tests | Proposed Device
Actual Data | | Acceptance Criteria | | Result | | |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------|---------------------|-----------------------------------|-------------|------|------|
| | | Size | Length
Width | Size | Length
Width | | | |
| 1. | Dimension
Length, Width and Thickness
ASTM D6319-19
ASTM D3767-03 | S | 243.69 mm
83.84 mm | S | 80±10 mm | Pass | | |
| | | M | 243.30 mm
94.15 mm | M | 230 mm
95±10 mm | | | |
| | | L | 242.84 mm
109.07 mm | L | min
110±10 mm | | | |
| | | XL | 242.15 mm
114.53 mm | XL | 120±10 mm | | | |
| | ASTM D3767-03
(Reapproved 2014)
Standard Specification for Nitrile
Examination Gloves for Medical
Application | Thickness | | | | | | |
| | | Size | Palm
Finger | Size | Palm
Finger | | | |
| | | S | 0.08 mm
0.12 mm | S | | | | |
| | | M | 0.12 mm
0.08 mm | M | 0.05 mm
0.05 mm | | | |
| | | L | 0.08 mm
0.10 mm | L | min
min | | | |
| | | XL | 0.09 mm
0.16 mm | XL | | | | |
| | Tensile Strength | | | | | | | |
| | | Size | Before
Aging
After
Aging | Size | Before
Aging
After
Aging | | | |
| | Physical property
Tensile strength and Ultimate
Elongation
ASTM D6319-19
ASTM D412-16
Standard Specification for Nitrile
Examination Gloves for Medical
Application | S | 31.26 MPa
23.51 MPa | S | | Pass | | |
| 2. | | M | 23.61 MPa
24.33 MPa | M | 14 MPa
14 MPa | | | |
| | | L | 20.55 MPa
21.6 MPa | L | min
min | | | |
| | | XL | 19.9 MPa
19.9 MPa | XL | | | | |
| | | Ultimate Elongation | | | | | | |
| | | Size | Before
Aging
After
Aging | Size | Before
Aging
After
Aging | | | |
| | | S | 799.76 %
815.61 % | S | | | | |
| | | M | 885.53 %
738.76 % | M | 500%
400% | | | |
| | | L | 849.69 %
708 % | L | min
min | | | |
| | | XL | 555.30 %
444.15 % | XL | | | | |
| 3. | Barrier property tests
Detection of Holes in Medical
Gloves
ASTM D6319-19
ASTM D5151-06
(Reapproved 2015)
Standard Test Method for
Detection of Holes in Medical
Gloves | S | AQL 2.5 | | S | AQL 1.5 | | Pass |
| | | 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 | | | | Pass | |
| | | S | 0.6 mg/glove | | S | ≤2 mg/glove | | |
| | | M | 0.7 mg/glove | | M | | | |
| | | L | 0.4 mg/glove | | L | | | |
| | | XL | 0.7 mg/glove | | XL | | | |

Table 2: Performance Testing Summary

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B. Biocompatibility

The materials used in the EONS Nitrile Examination Gloves Powder Free are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual:

· In Vitro Cytotoxicity
. Skin Sensitization
. Skin Irritation
· Acute Systemic Toxicity
· Material-Mediated Pyrogenicity

These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices -Part 1, Evaluation and Testing within a Risk Management Process.

| SI.

No	Test Performed	Standard	Proposed Device
1.	In vitro Cytotoxicity	ISO 10993-5:2009	Under the conditions of the study, the
device is cytotoxic. Additional testing
was performed to determine if this was
a systemic toxicity concern	Pass
2.	Skin Sensitization	ISO 10993-10:2010	Under the conditions of the study not a
sensitizer	Pass
3.	Skin Irritation	ISO 10993-10:2010	Under the condition of study not an
irritant	Pass
4.	Acute Systemic Toxicity	ISO 10993-11:2017	Under the condition of study, the device
extracts do not pose a systemic toxicity
concern	Pass
5.	Material-Mediated
Pyrogenicity	ISO 10993-11:2017(E)	Under the conditions of the study, the
device demonstrate a non-pyrogenic
response.	Pass

Table 3: Biocompatibility Test Summary

C. Clinical Test Data

Clinical study was not conducted, as clinical data is not needed for EONS Nitrile Examination Gloves Powder Free.

VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrate that the subject device, EONS Nitrile Examination Gloves Powder Free are as safe, as effective and perform as well as or better than legally marketed predicated device in K192333.