Black Nitrile Powder Free Patient Examination Glove, Non Sterile by Onetexx SDN BHD

A 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.

Device Description

Nitrile Powder Free Patient Examination Glove, Black Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: "Black Nitrile Powder Free Patient Examination Glove, Non Sterile". This document focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial for novel device performance.

Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment for a diagnostic algorithm (which is typical for AI/ML device submissions) is not applicable to this specific registration. This document describes the physical and chemical properties of a medical glove.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing performed to show equivalence with existing standards for examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

Characteristic	Standard	Acceptance Criteria	Reported Device Performance (Current Black Nitrile Glove)	Status
Physical Properties (ASTM D412)			Before Aging	After Aging
Tensile Strength	ASTM D412	Min 14.0 MPa	32.35 Mpa	36.10 Mpa
Ultimate Elongation	ASTM D412	Min 500%	568%	551%
Dimension (ASTM D3767)
Length	ASTM D3767	Min 240 mm	249 mm	N/A
Width	ASTM D3767	95 ± 10 mm	98.0 mm	N/A
Thickness - Finger	ASTM D3767	Min 0.05 mm	0.10 mm	N/A
Thickness - Palm	ASTM D3767	Min 0.05 mm	0.07 mm	N/A
Watertight (ASTM D5151)
AQL for Holes	ASTM D5151	AQL: 1.5, Acceptance No. 10 (for specified sample size)	0 pieces found with leaks (within acceptance criteria)	Pass
Residual Powder (ASTM D6124)
Powder Amount	ASTM D6124	Less than 2 mg per glove	0.24 mg/glove	N/A
Biocompatibility
Primary Skin Irritation	ISO 10993-10:2010 (E) & CPSCC Title 16, Ch. II, Part 1500	Passes (no irritant response)	Negligible	N/A
Dermal Sensitization	ISO 10993-10:2010 (E) & CPSCC Title 16, Ch. II, Part 1500.3 (c)(4)	Passes (no sensitization effect)	No skin sensitization effect	N/A
Cytotoxicity - MEM Elution	ISO 10993-5:2009 (E)	Passes	Cytotoxic effect observed, but Acute Systemic Toxicity tested	N/A
Acute Systemic Toxicity	ISO 10993-11:2017 (E)	Not applicable (for predicate)	No systemic toxicity induced	N/A

Further Requested Information (Not Applicable or Not Provided for this Device Type):

The following points are specifically relevant for AI/ML-powered diagnostic or decision support devices, which is not what this FDA submission is for. This document is for a physical medical glove. Therefore, the requested information below is not present in the provided text.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a physical medical glove. The non-clinical tests involved sampling of gloves for physical and chemical property testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. Ground truth for physical properties is established through standardized laboratory testing protocols, not expert consensus on diagnostic images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" is defined by the technical specifications and testing methods in the ASTM and ISO standards (e.g., a hole is a hole if water leaks, tensile strength is measured by a specific test).
The sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
How the ground truth for the training set was established: Not applicable.

Conclusion from document:

The provided document describes the non-clinical testing of a "Black Nitrile Powder Free Patient Examination Glove, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942). The tests show that the glove meets or exceeds the requirements of relevant ASTM and ISO standards for physical properties, dimensions, watertight integrity, residual powder, and biocompatibility, thus clearing it for market. No clinical studies or AI/ML algorithm evaluations were part of this 510(k) submission.

Summary

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October 31, 2021

Onetexx SDN BHD Wava Truscott Consultant 189 Burkemeade Ct. Roswell, Georgia 30075

Re: K210588

Trade/Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 25, 2021 Received: September 29, 2021

Dear Wava Truscott:

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.

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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 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.

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) K210588

Device Name BLACK NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE

Indications for Use (Describe)

A 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.

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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1.0 Submitter:

Name:	Freddy Low
Address:	Onetexx Sdn BhdNo: 73-86, Jalan Logam 5, Perindustrian Kamunting 3,Kamunting Raya Industrial Estate, 34600 Kamunting, PerakDarul Ridzuan, Malaysia.
Phone No.:	+60 5 8070 666
Fax No.:	+60 5 8070 666

Date of Summary Prepared: 20th February 2021

2.0 Identification of the subject device:

Trade Name	: Black Nitrile Powder Free Patient Examination Glove, Non-Sterile
Common Name	: Patient Examination Gloves
Classification Name	: Patient Examination Gloves
Device Classification	: 1
Regulation Number	: 21 CFR 880.6250
Product Code	: LZA.

3.0 Predicate Device:

K190942

Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co. Ltd.

4.0 Description of The Device:

Nitrile Powder Free Patient Examination Glove, Black Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.

5.0 Indication for use:

A patient examination qlove is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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6.0 Summary of the Technological Characteristics of the Device:

The Black Nitrile Powder Free Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.

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Table 1

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		COMPARISON ANALYSIS
		PREDICATEBLACK	CURRENTBLACK
510(k) Number	-	K190942
Manufacturer(s)	-	Ever Growth EnterpriseCorporation	Onetexx Sdn Bhd	Same
Material	ASTM D6319	Nitrile	Nitrile	Same
Color	-	Black	Black	Same
Physical Properties	ASTM D6319
Before AgingTensile Strength:Ultimate Elongation:		14Mpa, min500% min	32.35Mpa568%	Different butwithin the ASTMstandard
After AgingTensile Strength:Ultimate Elongation:		14Mpa, min400% min	36.10Mpa551%	Different butwithin the ASTMstandard
Thickness:- Finger- Palm	ASTM D6319	0.05mm min0.05mm min	0.10mm0.07mm	Different butwithin the ASTMstandard
Powder Free	ASTM D6124	< 2mg per glove	0.24 mg/glove	Different butwithin the ASTMstandard
	CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCEPREDICATEBLACK	CURRENTBLACK	COMPARISON ANALYSIS
		Primary Skin Irritation- ISO 10993-10:2010(E) & ConsumerProduct SafetyCommission Title 16.Chapter II, Part 1500	Passes	The test material did not causean irritant response. ThePrimary Irritant ResponseCategory is deemed 'Negligible'	Similar
		Dermal Sensitization-ISO 10993-10: 2010(E) & ConsumerProduct SafetyCommission, Title 16,Chapter II, Part1500.3 (c) (4)	Passes	The test material did notproduce a skin sensitizationeffect in the guinea pigs.	Similar
	Biocompatibility	Cytotoxicity - MEMElution, ISO 10993-5:2009 (E)	Passes	The test materialdemonstrated a cytotoxiceffect under the condition ofthis study. Additional test i.e.Acute Systemic Toxicity wastested.	Different - butadditional test ofAcute SystemicToxicity isconducted.
CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		COMPARISON ANALYSIS
		PREDICATEBLACK	CURRENTBLACK
Biocompatibility	Acute Systemic Toxicity, ISO 10993-11:2017 (E)	Not Applicable	The test item did not induce any systemic toxicity.	Different.
Watertight (1000ml)	ASTM D5151:2019	In accordance with ASTM D6319-10 and ASTM D5151-06 (reapproved 2011), G-1, AQL 2.5	Gloves passed AQL 1.5	Different, but within the ASTM standard.
Intended use	-	The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.	A patient examination glove is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.	Same
Size	Medical Glove Guidance Manual - Labeling	X SmallSmallMediumLargeX Large	Extra SmallSmallMediumLargeExtra Large	Same
Single use	Medical Glove Guidance Manual - Labeling	Yes	Single Use	Same

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There are no significant differences between the two products and are identical in terms of intended use, materials design, physical properties, thickness and biocompatibility test.

7.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

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TestMethod	Standard	Purpose of Testing	Acceptance Criteria		Results		Status
			Before aging	After aging	Before aging	After aging
PhysicalProperties	ASTM D412(Standard TestMethod forVulcanized Rubberand ThermoplasticElastomers-Tension)	To evaluate thetensile (tension)properties of glove.	Tensilestrength	Min 14.0 MPa	Min 14.0 MPa	32.35Mpa	36.10Mpa	Pass
			Ultimateelongation	Min 500%	Min 400%	568%	551%	Pass

TestMethod	Standard	Purpose ofTesting	Acceptance Criteria		Results		Status
Dimension	ASTM D3767Standard Practice forRubber—Measurement ofDimensions	To measure thelength, width andthickness ofglove	Length	Min 240 mm	Length	249mm	Pass
			Width	$95 \pm 10$ mm	Width	98.0mm	Pass
			Thickness	Finger – min 0.05mmPalm - min 0.05mm	Thickness	0.10mm0.07mm	Pass

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TestMethod	Standard	Purpose ofTesting	Acceptance Criteria	Results	Status
Watertight	ASTM D5151(Standard TestMethod forDetection of Holesin Medical Gloves)	To detect holesthat leak waterand therebycompromise theusefulness of theglove.	Sample size: 500 pcsInspection level: G1AQL: 1.5, Acceptance No. 10	The batch size for thissampling is 150,001 to500,000. Hence,according to the singlesampling plan GI, thesample to be drawn isunder code Mequivalent to 315pieces with accept 10and reject 11 to beaccepted under AQL1.5. During the test, 0piece was found withleaks. Hence it fallswithin the acceptancecriteria.	Pass

TestMethod	Standard	Purpose ofTesting	Acceptance Criteria	Results	Status
ResidualPowder	ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves)	To determine theamount ofresidual powderand non-powdersolids found ongloves.	Less than 2 mg per glove	Sample size : 5 pcsRequirement : <2mg/gloveResult :0.24mg/glove	Pass

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8.0 Summary of Clinical Testing:

No clinical study is included in this submission.

9.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject Black Nitrile Powder Free Patient Examination Glove, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K190942.

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.