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

Device Description

Dainam JSC., Powder Free Gloves are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile- butadiene copolymer dispersion. These gloves are blue in color and are powder free, non-sterile, single use and disposable and available in size XS-extra small, S-small, M-medium, L-Large, XL- Extra-large.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for a medical device (Powder Free Nitrile Examination Glove). It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical testing results.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test Method (Standard)	Purpose	Acceptance Criteria	Reported Device Performance (Result)
ASTM D6319-2019	Determine glove length	Min 230 mm for all sizes	X-Small: +/-240 mm, Small: +/-240 mm, Medium: +/-240 mm, Large: +/-240 mm, X-Large: +/-240 mm (All meet or exceed 230 mm)
ASTM D6319-2019	Determine glove width	X-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10mm, X-Large: 120+/-10 mm	X-Small: 70+/-10 mm, Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm (All meet criteria)
ASTM D6319-2019	Determine glove thickness	Palm 0.05 mm min, Finger 0.05 mm min for all sizes	X-Small Palm: 0.07mm Finger: 0.10mm, Small Palm: 0.07mm Finger: 0.9mm, Medium Palm: 0.07mm Finger: 0.9mm, Large Palm: 0.07mm Finger: 0.8mm, X-Large Palm: 0.07mm Finger: 0.7mm (All meet or exceed criteria)
ASTM D6319-2019	Determine physical properties - Tensile strength (Before Aging)	Before Ageing Tensile Strength 14Mpa Min for all sizes	X-Small: 27Mpa, Small: 26Mpa, Medium: 25Mpa, Large: 33Mpa, X-Large: 32Mpa (All meet or exceed 14 Mpa)
ASTM D6319-2019	Determine physical properties - Tensile strength (After Aging)	After Ageing Tensile Strength 14Mpa Min for all sizes	X-Small: 25Mpa, Small: 26Mpa, Medium: 27Mpa, Large: 36Mpa, X-Large: 33Mpa (All meet or exceed 14 Mpa)
ASTM D6319-2019	Determine physical properties - Ultimate Elongation (Before Aging)	Before Ageing Ultimate Elongation 500% Min for all sizes	X-Small: 520%, Small: 567%, Medium: 553%, Large: 568%, X-Large: 539% (All meet or exceed 500%)
ASTM D6319-2019	Determine physical properties - Ultimate Elongation (After Aging)	After Ageing Ultimate Elongation 400% Min for all sizes	X-Small: 509%, Small: 545%, Medium: 538%, Large: 560%, X-Large: 570% (All meet or exceed 400%)
ASTM D5151-2019	Determine holes in the gloves	AQL 2.5	Gloves Passes AQL 2.5
ASTM D6124-06 (Reapproved 2017)	Determine residual powder in the gloves	2 Mg/Glove Max	X-small: 0.3mg/glove, Small: 1.4mg/glove, Medium: 2 mg/glove, Large: 0.5 mg/glove, X-Large: 0.7mg/glove (All meet or are below 2 Mg/Glove)
ISO 10993-10 (Irritation)	Determine potential for dermal irritation in Rabbits	Under the condition of study not an irritant	Under the condition of study not an irritant
ISO 10993-10 (Sensitization)	Determine skin sensitization potential in Guinea Pig	Under the conditions of the study not a sensitizer	Under the conditions of the study not a sensitizer
ISO 10993-5:2009 (In vitro cytotoxicity)	Evaluate in vitro cytotoxic potential	Under the conditions of study non cytotoxic	Under the conditions of the study cytotoxic (This is an interesting result, as it states "cytotoxic" where the acceptance criteria states "non cytotoxic". This typically requires additional justification or risk assessment for FDA clearance.)
ISO 10993-11:2017 (Acute systemic toxicity)	Determine acute systemic toxicity potential in mice	Under the conditions of study, the device extracts do not pose a systemic toxicity concern	Under the conditions of study the device extracts do not pose a systemic toxicity concern
ISO 10993-11:2017 (Material Mediated Pyrogenicity)	Determine pyrogenic potential in Rabbits	Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response	Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists test methods (e.g., ASTM D6319-2019, ISO 10993 series) but does not specify the sample sizes used for each test for the subject device. It also does not specify the data provenance in terms of country of origin or whether the tests were retrospective or prospective. It only indicates that "Non-clinical tests were conducted to verify that the proposed device complies with the following standards".

3. 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)

This product is a medical examination glove, which is a physical device, not an AI or diagnostic imaging product. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the way it's described (e.g., radiologists for medical images) does not apply to this type of device. Performance is measured against established material and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The concept of an "adjudication method" (like 2+1 or 3+1 consensus) is relevant for studies involving human interpretation of data, particularly in diagnostics or AI algorithm validation. Since this document pertains to the physical and biocompatibility testing of a medical glove, this method is not applicable and not mentioned.

5. 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

This is a physical medical device (examination glove), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Again, this is a physical medical device. The concept of "standalone algorithm performance" does not apply. The tests performed are on the physical and chemical properties of the glove itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, "ground truth" is defined by the established ASTM and ISO standards for physical properties (like length, width, thickness, tensile strength, elongation, watertightness, powder residue) and biocompatibility (irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity). These standards themselves represent a consensus on what constitutes acceptable performance for such a device.

8. The sample size for the training set

This is a physical medical device, not an AI algorithm. Therefore, the concept of a "training set" for machine learning does not apply and no training set was used.

9. How the ground truth for the training set was established

As there is no training set for this type of device, this question is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

September 24, 2022

Dainam Glove Joint Stock Company % Jenny Nguyen Office Manager Bayneto LLC 13480 Veterans Memorial Drive, Suite F Houston, Texas 77014

Re: K212751

Trade/Device Name: Powder Free Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA Dated: August 16, 2022 Received: August 18, 2022

Dear Jenny Nguyen:

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.

{1}------------------------------------------------

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,

Bifeng Qian, M.D., 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212751

Device Name Powder Free Nitrile Examination Glove

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

PSC Publishing Services (301) 443-6740 EF

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

510(k) Summary - K212751

Submitted by:	Dai Nam JSC.1765A Thu Dau MotHiep An Ward, Thu Dau Mot, Vietnam.
Contact Person:	Damon NguyenDirector of U.S. Marketdqn1967@gmail.com
Telephone Number:	832-458-4388
Date submitted:	September 20, 2022
Trade/Device Name:	Powder Free Nitrile Examination Glove
Regulation Number:	21 CFR 880.6250
Regulation Name:	Non-powdered Patient Examination Glove
Regulatory Class:	Class I
Product Code:	LZA

Identification of the legally marketed device:

Predicate Device Name:	Powder Free Black Nitrile Examination Glove
Predicate 510(K) Number:	K201428
Manufacturer's Name:	VIETGLOVE CORPORATION

5.1 Product Description

5.2 Intended Use/Indications for Use

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

{4}------------------------------------------------

Product	K201428	K212751	Results
	(Predicate)	(Subject)
Design and SizeAvailability	S,M,L	XS,S,M,L,XL	Similar
Materials	Nitrile (Acrylonitrilebutadiene)	Nitrile (Acrylonitrilebutadiene)	Same
Intendeduse/Indicationfor Use	Non-Powdered PatientExamination Glove aredisposable gloves usedduring medicalexaminations andprocedures to helpprevent cross-contamination betweencaregivers and patients	Blue NitrileExamination GlovesPowder Free aredisposable devicesintended for medicalpurpose that are wornon the examiner's handto preventcontamination betweenpatient and examiner.	Similar
Color	Black	Blue	...
Product Code	LZA	LZA	Same
Classification	Class 1	Class 1	Same
510(K) Number	K201428	K212751	...

5.3 Comparison of Technological Characteristics

Characteristics	Standards	Device Performance		Comparison
		Predicate	Subject
510(K) Number		K201428	K212751	---
Name of device		Powder Free BlackNitrile ExaminationGlove	Powder Free NitrileExamination Glove	---
Dimensions	ASTM D6319-2019	Length Min 242 mWidth Min 95+/-10mm (for medium size)	Length Min 230 mmWidth Min 95+/-10mm (for medium size)	Similar
Characteristics	Standards	Device Performance		Comparison
		Predicate	Subject
PhysicalProperties	ASTM D6319-2019	Before AgingTensile Strength min14 Mpa UltimateElongation Min500%After Aging TensileStrength min 14 MpaUltimate ElongationMin 508%	Before AgingTensile Strength min14 MpaUltimate ElongationMin 500%After Aging TensileStrength min 14 MpaUltimate ElongationMin 505%	Similar
	Thickness	ASTM D6319-2019	Palm min 0.06 mm Fingermin 0.11 mm	Palm min 0.06 mmFinger min 0.09 mm
Powder Residue	ASTM D6319-2019	S: 0.43mg/gloveM: 0.31 mg/gloveL: 0.47 mg/glove	XS: 0.3mg/gloveS: 1.4mg/gloveM: 2.0 mg/gloveL: 0.5 mg/gloveXL: 0.7mg/glove	Similar
Biocompatibility	Primary Skin Irritation-ISO 10993-10:2010(E)	Under the condition ofstudy not an irritant	Under the conditionof study not an irritant	Same
	Dermal Sensitization-ISO 10993-10:2010(E)	Under the conditions of thestudy not a sensitizer	Under the conditionsof the study not asensitizer	Same
	In vitro cytotoxicityISO10993-5:2009(E)	Under the conditions of thestudy, cytotoxic	Under the conditions ofthe study cytotoxic	Same
	Acute Systemic ToxicityTest ISO 10993-11:2017(E)	Under the conditionsof study the device extractsdo not pose a systemictoxicity concern	Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern	Same
	Material MediatedPyrogenicityISO10993-11:2017(E) / USP41<151>	N/A	Under the conditions ofthe study the deviceextract did not show amaterial mediatedpyrogenicity response.	Different
Watertight (1000ml)	ASTM D5151-2019	Passes AQL-2.5	Passes AQL-2.5	Similar
Material	ASTM D6319-2019	Nitrile	Nitrile	Same
Color	-	Black	Blue	Different
Texture	-	Finger Texture	Finger texture	Same
Size	ASTMD6319-2019	Small, Medium, Large	Extra Small, Small,Medium, Large, ExtraLarge	Similar
Sterility	-	Non-sterile	Non-sterile	Same
Characteristics Standards		Device Performance		Comparison
		Predicate	Subject
Single Use	Medical GloveGuidance Manual	Single Use	Single Use	Same
Manufacturer(s)	-	VietgloveCorporation	DaiNam Glove JSC	------

{5}------------------------------------------------

{6}------------------------------------------------

5.4 Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device complies with the following standards:

1. ISO 10993-10:2009 MTT Method MEM with 10%FBS extract: In Vitro Cytotoxicity Test of NITRILE EXAM GLOVES.
1. ISO 10993-10:2010 Guinea Pig Maximization Test 0.9% sodium Chloride Injection Extract: Sensitization Test of NITRILE EXAM GLOVES.
1. ISO 10993-10:2010 0.9% sodium Chloride Injection Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
1. ISO 10993-10:2010 Guinea Pig Maximization Test Sesame Oil Extract: Sensitization Test of NITRILE EXAM GLOVES.
1. ISO 10993-10:2010 Sesame Oil Extract: Skin Irritation Test of NITRILE EXAM GLOVES.
1. ISO 10993-11:2017 Intravenous 0.9% Sodium Chloride Injection Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES.
1. ISO 10993-11:2017 Intravenous Sesame Oil Extract: Acute Systemic Toxicity Test of NITRILE EXAM GLOVES
1. ISO 10993-11:2017 0.9% Sodium Chloride Injection Extract Rabbit: Pyrogen Test of NITRILE EXAM GLOVES
1. ASTM D6319-19, Standard Specification for Gloves for Medical Application.

Test Method	Purpose	Acceptance Criteria	Result
ASTM D6319-2019 StandardSpecification for Gloves for MedicalApplication	To determine thelength of the gloves	Min 230 mm for all sizes	X-Small: +/-240 mmSmall: +/-240 mmMedium: +/-240 mmLarge: +/-240 mmX-Large: +/-240 mm
ASTM D6319-2019 StandardSpecification for Gloves forMedical Application	To determine thewidth of the gloves	X-Small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10mmLarge: 110+/-10mm X-Large: 120+/-10 mm	X-Small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10mmLarge: 110+/-10 mmX-Large: 120+/-10 mm
ASTM D6319-2019 StandardSpecification for Gloves for MedicalApplication	To determine theThickness of thegloves	Palm 0.05 mm minFinger 0.05 mm min for allsizes	Size Palm Finger X-Small 0.07mm 0.10mm Small 0.07mm 0.9mm Medium 0.07mm 0.9mm Large 0.07mm 0.8mm X-Large 0.07mm 0.7mm

{7}------------------------------------------------

Test Method	Purpose	Acceptance Criteria	Size	Result
ASTM D6319-2019 StandardSpecification for Gloves forMedical Application	To Determine thephysical properties-Tensile strength	Before Ageing TensileStrength 14Mpa Min forall sizesAfter Ageing TensileStrength 14Mpa Min forall sizes	X-SmallSmallMediumLargeX-Large	Beforeageing27Mpa26Mpa25Mpa33Mpa32Mpa	Afterageing25Mpa26Mpa27Mpa36Mpa33Mpa
	To Determine thephysical properties-Ultimate Elongation	Before AgeingUltimate Elongation500% Min for allsizesAfter AgeingUltimateElongation 400%Min for all sizes	X-SmallSmallMediumLargeX-Large	Beforeageing520%567%553%568%539%	Afterageing509%545%538%560%570%

Test Method	Purpose	AcceptanceCriteria	Result
ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves	To determine theholes in the gloves	AQL 2.5	Gloves Passes AQL 2.5
ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves	To determine theresidual powder inthe gloves	2 Mg/Glove Max	SizeX-small 0.3mg/gloveSmall 1.4mg/gloveMedium 2 mg/gloveLarge 0.5 mg/gloveX-Large 0.7mg/glove

5.5 BIOCOMPATIBILITY DATA

{8}------------------------------------------------

Test Method	Purpose	AcceptanceCriteria	Result
ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done forirritation.	To determine the potential ofthe glove under test toproduce dermal irritation inRabbits	Under the conditionof study not an irritant	Under the condition ofstudy not an irritant
ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done Skinsensitization.	To determine the skinsensitization potential ofthe glove in Guinea Pig.	Under the conditionsof the study not asensitizer	Under the conditions ofthe study not asensitizer
ISO 10993-5:2009 biologicalevaluation of medical devices -part 5, tests for in vitrocytotoxicity.	To evaluate the in vitrocytotoxic potential of the testitem in L-929 mousefibroblasts cells using elutionmethod.	Under the conditionsof study non cytotoxic	Under the conditions ofthe study cytotoxic.
ISO 10993-11:2017 biologicalevaluation of medical devices -part 11, tests for systemictoxicity.	To determine the acutesystemic toxicity potential ofthe test item extracts in mice.	Under the conditionsof study, the deviceextracts do not posea systemic toxicityconcern	Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern
Material Mediated PyrogenicityISO 10993- 11:2017	To determine the pyrogenicpotential of the test itemextract following intravenousinjection in Rabbits.	Under the conditionsof the study, thedevice did notdemonstrate amaterial mediatedpyrogenicity response.	Under the conditions ofthe study, the device didnot demonstrate amaterial mediatedpyrogenicity response.

5.6 Summary of Clinical Testing

Not applicable - Clinical data is not needed for the subject gloves.

5.7 Conclusion

The conclusions drawn from the non-clinical test demonstrate that the subject device is as safe as effective and performs as well as or better than the legally marketed predicated device.

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.