Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical product (examination gloves) and the description and testing focus on material properties and physical performance, with no mention of software, algorithms, or data processing.

Therapeutic

No
The device, Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner, serving as a barrier, not to treat or mitigate a disease or condition.

Diagnostic

No
The device is described as examination gloves used to prevent contamination, not to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (nitrile examination gloves) and the performance studies focus on physical properties and material standards, not software functionality.

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 to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as examination gloves, which are a physical barrier.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on the physical properties of the gloves (strength, elongation, freedom of holes, etc.), which are relevant to their barrier function, not diagnostic accuracy.
No Mention of IVD-related terms: There are no terms like "assay," "reagent," "analyzer," "sample," or other terms typically associated with IVD devices.

In summary, the device is a medical device intended for barrier protection, not for performing in vitro diagnostic tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — 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 or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner / 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)

Test results below demonstrated that the proposed device complies with the following specification and guidance:

ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Guidance for Industry and FDA Staff Medical Glove Guidance Manual (Document issued on January 22, 2008)

The following standards were followed to carry out the testing:

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.
ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers -Tension
ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM D573 - 04 Standard Test Method for Rubber—Deterioration in an Air Oven

Summary of Non-Clinical Performance Data:

Test Method	Purpose	Acceptance Criteria	Result
ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application	To determine the length of the gloves	Length >= 230 mm for all sizes	Pass
ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application	To determine the width of the gloves	Size S – 85 +/- 5 mm Size M – 95 +/- 5 mm Size L – 105 +/- 5 mm Size XL – 115 +/- 5 mm	Pass
ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application	To determine the thickness of the gloves	Finger >= 0.05 mm Palm >= 0.05 mm for all sizes	Pass
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.	To determine the holes in the gloves	Accept: 5 out of 125 pieces sample size	Pass
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.	To determine the residual powder in the gloves	= 14 MPa After aging >= 14 MPa	Before aging, Average: 24.83 MPa Median: 24.90 MPaAfter aging, Average: 26.23 MPa Median: 25.95 MPa
	To determine the physical properties – Ultimate Elongation	Ultimate Elongation: Before aging >= 500 % After aging >= 400 %	Before aging, Average: 509.23 % Median: 500 %After aging, Average: 436.92 % Median: 440 %

Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicated device, K172642, Orange Non Sterile Powder Free Nitrile Examination Gloves.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172642

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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 and 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.

September 2, 2021

Great Eco Glove Sdn. Bhd. Soh Li QA/OC Manager Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya, Selangor 45600 Malaysia

Re: K210868

Trade/Device Name: Nitrile Examination Gloves Powder Free (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 6, 2021 Received: August 6, 2021

Dear Soh Li:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 mediation-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,

Liqun Zhao -S

For Clarence W. Murray, III, 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) K210868

Device Name

Nitrile Examination Gloves Powder Free (Blue)

Indications for Use (Describe)

Disposable device intended for medical purpose that is worn on the examiner's hand or finger 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 the logo for GREAT ECO GLOVE SDN BHD (970327-V). The logo consists of a stylized globe on the left, with the company name in red and green text to the right of the globe. The company registration number is in parentheses after the company name.

1.0 510(k) Summary – K210868

1.1 Submitter:
Name:	Great Eco Glove Sdn. Bhd.
Address:	Lot 1675, Jalan Makmur, Batu 28, Ijok,
	45600, Bestari Jaya, Selangor, Malaysia.
Contact:	+603-3279 2199 / +603-3279 3633
1.2 Contact Person:
Name:	Dr. Neoh Vee Heng (Executive Chairman)
Email:	drneoh.geg@gmail.com
Name:	Mr. Ian Neoh Puay Guan (Assistant General Manager)
Email:	iannpg.geg@gmail.com
Name:	Ms. Shahnaz Sakinah Binti Shaiful Bahri (QA/QC Executive)
Email:	qaqc.geg@gmail.com
Date of summary prepared:	23rd December 2020
1.3 Name of Device:
Trade Name:	Nitrile Examination Gloves Powder Free (Blue)
Common Name:	Patient Examination Glove
Classification Name:	Patient Examination Glove
Classification Regulation:	21 CFR 880.6250

Device Class: l Product Code: LZA Classification Panel: General Hospital

Legally Marketed Predicate Device: 1.4

	Predicate Device
Manufacturer	Central Medicare Sdn. Bhd.
Trade Name	Orange Non Sterile Powder Free
Nitrile Examination Gloves
510 (k) Number	K172642
Product Code	LZA
Classification
Regulation	21 CFR 880.6250
Device Class	I

4

Image /page/4/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD. The logo features a stylized globe on the left, with the company name in red and green text to the right of the globe. The registration number (970327-V) is in smaller text to the right of the company name.

Device Description: 1.5

Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — Standard Specification for Nitrile Examination Gloves for Medical Application.

1.6 Intended Use:

Nitrile Examination Gloves Powder Free (Blue) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Technological Characteristics: 1.7

Nitrile Examination Gloves Powder Free (Blue) have either similar or the same technological characteristics as compared to the legally marketed predicated device, K172642, Orange Non Sterile Powder Free Nitrile Examination Gloves:

| Characteristics | Standards | Proposed Device:
K210868 | Predicate Device:
K172642 | Comparison |
|------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | General | | |
| Manufacturer | N/A | Great Eco Glove Sdn.
Bhd. | Central Medicare Sdn.
Bhd. | N/A |
| Trade Name | N/A | Nitrile Examination
Gloves Powder Free
(Blue) | Orange Non Sterile
Powder Free Nitrile
Examination Gloves | Different |
| Product Code | N/A | LZA | LZA | Same |
| Classification
Regulation | N/A | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device Class | N/A | I | I | Same |
| Indication
for
use | N/A | Nitrile Examination
Gloves Powder Free
(Blue) is a disposable
device intended for
medical purpose that
is worn on the
examiner's hand or
finger to prevent
contamination
between examiner
and patient. | Orange Non Sterile
Powder Free Nitrile
Examination Gloves is
a disposable device
intended for medical
purposes that is worn
on the examiner's
hands to prevent
contamination
between patient and
examiner. | Same |
| Material
Composition | ASTM D6319-10
(2015) | Synthetic nitrile
rubber | Synthetic nitrile
rubber | Similar |
| Color | N/A | Blue | Orange | Different |
| Design | N/A | Non-sterile
Single use
Powder free | Non-sterile
Single use
Powder free | Same |
| | | Ambidextrous | Ambidextrous | |
| | | Beaded cuff | Beaded cuff | |
| Labeling | N/A | Meet FDA's
recommendations | Meet FDA's
recommendations | Similar |
| | | Performance | | |
| | | Length ≥ 230 mm | Length ≥ 230 mm | Similar |
| | | Palm Width: | Palm Width: | Similar |
| | ASTM D6319-10
(2015) | Size S - 85 ± 5 mm | Size S - 80 ± 10 mm | |
| | | Size M - 95 ± 5 mm | Size M - 95 ± 10 mm | |
| Dimension | | Size L - 105 ± 5 mm
Size XL - 115 ± 5 mm | Size L - 110 ± 10 mm
Size XL - 120 ± 10 mm | |
| | | Thickness:
Finger ≥ 0.05 mm
Palm ≥ 0.05 mm | Thickness:
Finger ≥ 0.05 mm
Palm ≥ 0.05 mm | Similar |
| | | Tensile Strength:
Before aging ≥ 15
MPa
After aging ≥ 14 MPa | Tensile Strength:
Before aging ≥ 15
MPa
After aging ≥ 14 MPa | Similar |
| | ASTM D6319-10
(2015) | Ultimate Elongation:
Before aging ≥ 500 %
After aging ≥ 400 % | Ultimate Elongation:
Before aging ≥ 500 %
After aging ≥ 400 % | Similar |
| Physical
Properties | | | | |
| | | | | |
| | ASTM D6319-10
(2015)
ASTM D5151-19 | Passes or exceeds
ASTM D6319-10
(2015) and ASTM
D5151-19
requirements of AQL
2.5 / Inspection level
G1 | Passes or exceeds
ASTM D6319-10
(2015) and ASTM
D5151-19
requirements of AQL
2.5 / Inspection level
G1 | Similar |
| Freedom of
Holes | | | | |
| | | | | |
| Powder
Content | ASTM D6319-10
(2015)
ASTM D6124-06
(2011) | ≤ 2 mg/glove | ≤ 2 mg/glove | Similar |
| Biocompatibility | ISO 10993-
10:2010 | Primary Skin Irritation:
Under conditions of
the study not an
irritant | Primary Skin
Irritation: Under
conditions of the
study not an irritant | Similar |
| | | | | |
| | | Dermal Sensitization:
Under conditions of
the study not a
sensitizer | Dermal Sensitization:
Under conditions of
the study not a
sensitizer | |

5

GREAT ECO GLOVE SDN BHD (970327-V)

6

Image /page/6/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD. The logo features a green and blue globe graphic on the left. To the right of the graphic is the company name in red and green text, with the registration number (970327-V) in parentheses.

Summary of Non-Clinical Performance Data: 1.8

Test results below demonstrated that the proposed device complies with the following specification and guidance:

ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. -
-Guidance for Industry and FDA Staff Medical Glove Guidance Manual (Document issued on January 22, 2008)

The following standards were followed to carry out the testing:

-ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
-ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.
ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
-ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers -Tension -
ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves -
-ASTM D573 - 04 Standard Test Method for Rubber—Deterioration in an Air Oven

7

GREAT ECO GLOVE SDN BHD (970327-V)

Non-clinical Testing Summary

Test Method	Purpose	Acceptance Criteria
ASTM D6319-10
(Reapproved 2015)
Standard Specification
for Nitrile Examination
Gloves for Medical
Application	To determine
the length of the
gloves	Length ≥ 230 mm for all
sizes	Pass
ASTM D6319-10
(Reapproved 2015)
Standard Specification
for Nitrile Examination
Gloves for Medical
Application	To determine
the width of the
gloves	Size S – 85 ± 5 mm
Size M – 95 ± 5 mm
Size L – 105 ± 5 mm
Size XL – 115 ± 5 mm	Pass
ASTM D6319-10
(Reapproved 2015)
Standard Specification
for Nitrile Examination
Gloves for Medical
Application	To determine
the thickness of
the gloves	Finger ≥ 0.05 mm
Palm ≥ 0.05 mm for all
sizes	Pass
ASTM D5151-19
Standard Test Method
for Detection of Holes in
Medical Gloves.	To determine
the holes in the
gloves	Accept: 5 out of 125
pieces sample size	Pass
ASTM D6124-06
(Reapproved 2017),
Standard Test Method
for Residual Powder on
Medical Gloves.	To determine
the residual
powder in the
gloves	≤ 2 mg/glove	Pass (0.70 mg/glove)

| ASTM
D6319-10
(Reapproved 2015)
Standard Specification
for Nitrile Examination
Gloves for Medical
Application | To determine
the physical
properties -
Tensile strength | Tensile Strength:
Before aging ≥ 14 MPa
After aging ≥ 14 MPa | Before aging,
Average: 24.83 MPa
Median: 24.90 MPa

After aging,
Average: 26.23 MPa
Median: 25.95 MPa |
|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | To determine
the physical
properties –
Ultimate
Elongation | Ultimate Elongation:
Before aging ≥ 500 %
After aging ≥ 400 % | Before aging,
Average: 509.23 %
Median: 500 %

After aging,
Average: 436.92 %
Median: 440 % |

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Image /page/8/Picture/0 description: The image shows the logo for Great Eco Glove SDN BHD. The logo features a stylized globe graphic on the left. The text "GREAT ECO GLOVE SDN BHD" is in red and green, followed by the registration number "(970327-V)" in black.

1.9 Summary of Clinical Performance Data:

Clinical data is not necessary for Class I Patient Examination Glove 510(k) Submissions.

1.10 Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicated device, K172642, Orange Non Sterile Powder Free Nitrile Examination Gloves.