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, ML, or any related technologies.

Therapeutic

No
The gloves are intended to prevent contamination and are for examination purposes, not for treating a condition or disease.

Diagnostic

No
Explanation: The device is described as an examination glove intended to prevent contamination between a patient and examiner. It does not perform any diagnostic function such as identifying a disease or condition.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of Nitrile, clearly described as a disposable device worn on the hand. It is a hardware product, not software.

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 clearly states the device is "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The description confirms it's a "patient examination glove," which is a physical barrier device.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.

IVD devices are designed to perform tests on samples from the human body to provide information for the diagnosis, treatment, or prevention of disease. This glove does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ComfortPro Blue Nitrile Examination Gloves Powder free is 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

ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.

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)

The device underwent non-clinical performance testing for physical properties (length, width, thickness, tensile strength, ultimate elongation, powder residue, water tight) and biocompatibility (Primary Skin Irritation, Dermal Sensitization, In vitro cytotoxicity, Acute Systemic Toxicity Test). All physical properties met the acceptance criteria as per ASTM D 6319-19 and ASTM D 5151-19, and ASTM D 6124-06. Biocompatibility tests met the acceptance criteria as per ISO 10993-10:2010(E), ISO10993-5:2009(E), and ISO 10993-11:2017(E).

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K202384

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

December 10, 2021

Thai Rubber Industry Company Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, Illinois 60504

Re: K212850

Trade/Device Name: ComfortPro Blue 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: August 13, 2021 Received: September 7, 2021

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

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) K212850

Device Name

ComfortPro Blue Nitrile Examination Gloves Powder free

Indications for Use (Describe)

ComfortPro Blue Nitrile Examination Gloves Powder free 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):

	Commercial
	Residential

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K212850 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)

A. APPLICANT INFORMATION

510(K) Owner's Name	THAI RUBBER INDUSTRY COMPANY LIMITED
Address	738 MOO 5, MANAM KOO,
PLUAKDAENG
RAYONG 21140 THAILAND
Phone	+66-098-2520209
Fax	-
E-mail	vanida@thairubberindustry.com
Contact Person	Ms. Supawadee Phoungthong
Designation	Managing Director
Contact Number	+66-098-2520209
Contact Email	vanida@thairubberindustry.com
Date Submitted	December 9, 2021

B. DEVICE IDENTIFICATION

| Name of the device | ComfortPro Blue Nitrile Examination Gloves
Powder Free |
|-----------------------------------|-----------------------------------------------------------|
| Product proprietary or trade name | ComfortPro |
| Common or usual name | Nitrile Examination Gloves |
| Classification name | Polymer Patient Examination Glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

C. PREDICATE DEVICE

Predicate Device	Hi-Care Thai Gloves Co. Ltd.
510(k) Number	K202384
Regulatory Class	Class 1
Product code	LZA

D. DESCRIPTION OF THE DEVICE:

ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.

E. INDICATION FOR USE OF THE DEVICE:

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

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510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)

F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE			REMARKS
		PREDICATE	SUBJECT
510(K) Number		K202384	K212850
Name of device	--	Palm Care Blue Nitrile	ComfortPro Blue Nitrile
		Examination Gloves	Examination Gloves		----
		Powder free	Powder Free
Dimensions- Length	ASTMD 6319-19	Length Min 230 mm	Length > 230 mm		Similar
			Size	Average
			X-Small	250
			Small	241
			Medium	245
			Large	242
			X- Large	242
Dimensions- Width	ASTMD 6319-19	Width Min 95+/-10mm	Width Min 95+/-10mm		Similar
		(for medium size)	(for medium size)
			Size	Average
			X-Small	80
			Small	82
			Medium	93
			Large	103
			X- Large	110
Physical Properties-	ASTMD 6319-19	Before Ageing	Before Ageing
Tensile Strength		Tensile Strength	Tensile Strength >
		min 14 Mpa
After Ageing	14 Mpa
Size	Average
		Tensile Strength			Similar
		min 14 Mpa	X-Small	27.2
			Small
Medium	23.2
				24
			Large	26.2
			X- Large	27.4
				After Ageing
			Tensile Strength >
			14 Mpa
			Size	Average
			X-Small
Small	24.2
23.8
			Medium	27.6
			Large	27.6
			X- Large	27.9
Physical Properties-	ASTMD 6319-19	Before Ageing			Similar
Ultimate Elongation		Ultimate Elongation	Before Ageing
Ultimate Elongation >
500%
		> 500%
			X-Small	620
			Small	290
			Medium	570
			Large	570
			X- Large	રરા



CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		REMARKS
		PREDICATE	SUBJECT
	ASTMD 6319-19	After Ageing
Ultimate
Elongation >400%	After Ageing
Ultimate Elongation > 400%
X-Small 600
Small 560
Medium 540
Large 540
X- Large 550	Similar
Thickness	ASTMD 6319-19	Palm min 0.05 mm
Finger min 0.05 mm	Palm > 0.05 mm Finger > 0.05 mm
Size Palm (Actual value) mm Finger (Actual value) mm
X-Small 0.101 0.121
Small 0.081 0.097
Medium 0.091 0.108
Large 0.092 0.108
X- Large 0.091 0.111	Similar
Powder Residue	ASTMD 6319-19	Before Ageing
Tensile Strength 14
Mpa Min for all
sizes
After Ageing
Tensile Strength
14Mpa Min for all
sizes	Size	Before ageing	After ageing
			X-Small	27.2 Mpa	24.2 Mpa
			Small	23.2 Mpa	23.8 Mpa
			Medium	24 Mpa	27.6 Mpa
			Large	26.2 Mpa	27.6 Mpa
			X Large	27.4 Mpa	27.9 Mpa
	To Determine the
physical properties-
Ultimate Elongation	Before Ageing
Ultimate
Elongation
500% Min for all
sizes
After Ageing
Ultimate
Elongation 400%
Min for all sizes	Size	Before ageing	After ageing
			X-Small	620%	600%
			Small	590%	560%
			Medium	570%	540%
			Large	570%	540%
			X Large	550%	550%
ASTMD 5151-19
Standard Test
Method for
Detection of
Holes in Medical
Gloves	To determine the
holes in the gloves	AQL 2.5	Gloves Passes AQL 2.5
ASTM D6124-06
(Reapproved

Standard
Test Method for
Residual Powder
on Medical
Gloves | To determine the
residual powder in
the gloves | ≤2 Mg/Glove | 0.49 mg/glove | | |

BIOCOMPATIBILITY DATA

| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------|
| ISO 10993-10:2010( E)
Biological Evaluation Of
Medical Devices - Part 10:
Tests For Irritation And Skin
Sensitization.
Test done for irritation. | To evaluate the test item,
for skin irritation test in
New Zealand White
rabbits. | Under the condition
of study not an
irritant | Under the condition of
study, not an irritant |

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510(K) SUMMARY AS REQUIRED BY: 21CFR8807.92(C)

| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993 10:2010(E)
Biological Evaluation of
Medical Devices - Part 10:
Tests for Irritation and Skin
Sensitization.
Test done for skin sensitization | To evaluate the test item,
for the Skin Sensitization
in Guinea pigs by
maximization test. | Under the conditions
of the study, not a
sensitizer | Under the conditions of the
study, not a sensitizer |
| ISO10993-5:2009(E)
Biological evaluation of
medical devices - part 5, tests
for In vitro cytotoxicity. | To evaluate the test item,
for its ability to induce
cytotoxicity using L-929
mouse fibroblast cells by
Elution Method. | Under the conditions
of the study, non-
cytotoxic | Under the conditions of the
study cytotoxic for 100% test
item extract and non-
cytotoxic at 50%, 25%,
12.5% and 6.25% test item
extracts. Moreover, under the
conditions of the study, non
acute systemic toxic. |
| ISO 10993-11:2017(E)
Biological evaluation of
medical devices - part 11, tests
for systemic toxicity. | To evaluate the test item,
for Acute Systemic
Toxicity in Swiss Albino
Mice. | Under the conditions
of study, the device
extracts do not pose
a systemic toxicity
concern | Under the condition of
study, the device extracts
did not reveal any
systemic toxicity. |

The performance test data of the non-clinical tests demonstrates that the subject device meet the acceptance criteria and the specifications found in the standards and test methodology.

The performance test data of the non-clinical tests meet following standards:

ASTMD 6319-19 Standard Specification for Nitrile examination gloves for medical Application.

ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves

ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

ISO 10993-5:2009 (E) Biological evaluation of medical devices - part 5, tests for In vitro cytotoxicity.

ISO 10993-11:2017(E) biological evaluation of medical devices - part 11, tests for systemic toxicity.

H. COMPARISON BASED ON ASSESSMENT OF CLINICAL PERFORMANCE DATA

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

I. CONCLUSION

The conclusions drawn from the non-clinical tests demonstrate that the subject device in 510(K) submission, ComfortPro Blue Nitrile Examination Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384.