Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

AI/ML Overview

The provided text describes the acceptance criteria and the study results for the "Disposable Medical Rubber Examination Gloves" (K221374) device.

Here's the breakdown of the requested information:

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

Category	Test Item	Acceptance Criteria	Reported Device Performance
Biocompatibility	Acute Systemic Toxicity Test	ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.	The test article has no potential acute systemic toxicity on ICR mice in the extraction method.
	Skin Irritation Test	ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation.	Under the experimental conditions, the test article has no skin irritation on rabbits.
	Skin Sensitization Test	ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.	Under the experimental conditions, the test article has no potential skin sensitization on guinea pigs in the method.
Physical Properties	Physical Dimensions Test	The gloves shall comply with the dimension requirements prescribed in ASTM D3578-19 Table 2. (Inspection Level: S-2, AQL: 4.0) (Specific dimensions for Length, Width, and Thickness are detailed in the "Characteristics" table earlier, but the acceptance criteria generally refer to this ASTM standard and AQL levels)	The subject device comply with the dimension requirements prescribed in ASTM D3578-19. (e.g., Length (mm): 230 min; Width (mm) for XS: 75 ± 5, S: 85 ± 5, M: 95 ± 5, L: 105 ± 5, XL: 115 ± 5; Thickness (mm) For all sizes: 0.08 min.)
	Physical Property Characteristics Test (Tensile Strength & Ultimate Elongation)	Before and after accelerated aging, the gloves shall conform to the physical requirements specified in ASTM D3578-19 Table 3. (Inspection Level: AQL: 4.0) Before Aging: Tensile Strength 18 MPa, min; Ultimate Elongation 650 % min After Accelerated Aging: Tensile Strength 14 MPa, min; Ultimate Elongation 500 % min	Before and after accelerated aging, the subject device conform to the physical requirements specified in ASTM D3578-19 Table 3. Before Aging: Tensile Strength 18MPa, min; Ultimate Elongation 650 % min After Accelerated Aging: Tensile Strength 14 MPa, min; Ultimate Elongation 500 % min (Actual values provided in comparison table: e.g., Tensile Strength Before Aging >18.04 MPa, After Aging >15.02 MPa across sizes; Ultimate Elongation Before Aging >650%, After Aging >501% across sizes)
	Freedom From Holes Test	Inspection Level: I, AQL: 2.5	No water leakage is inspected. The subject device conform to the requirements specified in ASTM D5151. (AQL 2.5)
	Powdered Glove Test (Residual Powder)	Inspection Level: N=5, Residual Powder less than 2 mg per glove.	Residual Powder less than 2 mg per glove. The subject device conform to the requirements specified in ASTM D6124. (Reported values: XS 0.28, S 0.25, M 0.31, L 0.25, XL 0.35 mg/glove)
	Extractable Protein Test	Inspection Level: N=3, Less than 200 µg/dm².	The results showed that the average Extractable Protein of test samples met the acceptance criteria in ASTM D5712. (Reported values: Small 124.36, Medium 140.78, Large 134.26, Extra Large 159.46 µg/dm²)

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

Sample Size for Physical Dimension, Physical Property, Freedom From Holes, Powdered Glove, and Extractable Protein Tests: The sample sizes are specified by the ASTM standards and AQL levels. For example:
- Physical Dimensions: Inspection Level S-2, AQL 4.0 (This implies a sampling plan defined by ASTM D3578-19, which would dictate the sample size based on lot size).
- Physical Property Characteristics: AQL 4.0 (similar to above).
- Freedom From Holes: Inspection Level I, AQL 2.5 (implies a sampling plan as per ASTM D5151-06).
- Powdered Glove Test: N=5 (5 gloves were tested for residual powder).
- Extractable Protein Test: N=3 (3 samples were tested for extractable protein).
Sample Size for Biocompatibility Tests:
- Acute Systemic Toxicity: ICR mice (number not specified, but typically a standard number per group as per ISO 10993-11).
- Skin Irritation: Rabbits (number not specified, but typically a standard number as per ISO 10993-23).
- Skin Sensitization: Guinea pigs (number not specified, but typically a standard number as per ISO 10993-10, using the Guinea Pig Maximization method).
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they are "bench tests" and "nonclinical tests" conducted for the subject device manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd. in China.

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 information is not applicable as the document describes performance testing of a physical medical device (examination gloves) against established engineering and biocompatibility standards, not an AI/imaging device requiring expert interpretation for ground truth.

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

This information is not applicable for the same reason as point 3. The device under review is an examination glove, and its performance is determined by objective physical and chemical tests, not by human interpretation or adjudication.

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 information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.

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

This information is not applicable. This document describes an examination glove, not an AI-assisted diagnostic device.

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

The "ground truth" for the performance of the Disposable Medical Rubber Examination Gloves is established by:

International Standards: Primarily ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties and dimensions, and various ISO 10993 series standards for biocompatibility (ISO 10993-11 for systemic toxicity, ISO 10993-23 for irritation, ISO 10993-10 for sensitization).
Objective Test Methods: Laboratory tests as described (e.g., steel ruler and thickness measurement apparatus for dimensions, dumbbell/straight section specimens for physical properties, water leakage for holes, gravimetric methods for residual powder, modified Lowry Method for protein content).
Animal Models: For biocompatibility tests (ICR mice for acute systemic toxicity, rabbits for skin irritation, guinea pigs for skin sensitization).

8. The sample size for the training set

This information is not applicable. The device is a physical product (examination gloves), not a software algorithm that requires a training set. The performance is based on manufacturing and testing against established standards.

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

This information is not applicable for the same reason as point 8.

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.

October 26, 2022

Hebei Titans Hongsen Medical Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 China

Re: K221374

Trade/Device Name: Disposable Medical Rubber Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: September 27, 2022 Received: September 27, 2022

Dear Ray Wang:

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,

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

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Indications for Use

510(k) Number (if known) K221374

Device Name

Disposable Medical Rubber Examination Gloves

Indications for Use (Describe)

Disposable Medical Rubber Examination Gloves are 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K221374

1. Date of Preparation: 10/25/2022
1. Submitter

Hebei Titans Hongsen Medical Technology Co., Ltd.

Eastern Industrial Zone, Nangong City, Xingtai City, 051800, Hebei, China

Contact Person: Chai Wu Position: Quality Director Tel: +86-17769045117 Email: hszj@titans-cn.com

1. Submission Correspondent

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com

1. Subject Device Identification
  Trade Name: Disposable Medical Rubber Examination Gloves

Common Name: Latex Patient Examination Glove

Regulatory Information: Classification: I Product Code: LYY Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

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న. Predicate Device Identification

K210253

BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE

BESTSAFE GLOVE CO., LTD

Regulatory Information:

Classification: I

Product Code: LYY

Regulation Number: 21 CFR 880.6250

Review Panel: General Hospital

Common Name: Latex Patient Examination Glove

Device Description 6.
The Disposable Medical Rubber Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

Characteristics	Subject Device
Single use	Single use
Sterile/Non Sterile	Non Sterile
Dimension	Length (mm): 230 min.
	Width (mm)
	Size Width XS 75 ± 5 S 85 ± 5 M 95 ± 5 L 105 ± 5 XL 115 ± 5
	Thickness (mm) For all sizes: 0.08 min.
Physical Properties	Type I
	Before Aging After Accelerated Aging Tensile Strength 18MPa, min 14 MPa, min Ultimate Elongation 650 % min 500 % min
Freedom from holes	No water leakage is inspected. AQL 2.5
Powder Free Residue	Size Residual powder content (mg/glove) XS 0.28 S 0.25 M 0.31 L 0.25 XL 0.35

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Protein Content	Meet the requirements of ASTM D5712, Less than 200 $ \mu $ g/dm2
Biocompatibility	Biocompatible

7. Indication For Use Statement

Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

1. Technological Characteristic Comparison Summary
  The subject device has same indication for use, design (single use, non-sterile), powdered free and material with the predicate device.

The subject is different with the predicate device in dimensions, physical properties, powder free residue and protein content. But both subject device and predicate device meet the requirements of ASTM D3578-19, Standard Specification for Rubber Examination Gloves, so we conducted the testing as this standard, the test results show that the subject device meet the requirements of this standard, so these different in dimensions, physical properties, powder free residue and protein content would not raise new safety concerns.

ITEM	References/Standard	Proposed Device	Predicate Device K210253	Remark
Intended Use	/	Disposable Medical Rubber ExaminationGloves are disposable device intended formedical purpose that is worn on the examiner'shand to prevent contamination between patientand examiner.	A powder-free patient examination glove is a disposabledevice intended for medical purposes that is worn on theexaminer's hand or finger to prevent contamination betweenpatient and examiner.	SAME
Material	/	Natural Rubber Latex	Natural Rubber Latex	SAME
Color	/	Natural White	Natural Color	SAME
OTC use	/	Yes	Yes	SAME
Single Use	/	Yes	Yes	SAME
Sterile	/	Non-sterile	Non-sterile	SAME
Dimension(Length,Width,Thickness)	ASTM D3578S-2 AQL 4.0	Length (mm) min	Length (mm) min	Similar
		Size	SizeActual value
		XS	Small240
		S	Medium240
		M	Large240
		L	Extra Large241
		XL	/
		Width (mm)	Width (mm)	Similar
		SizeWidth	SizeActual value
		XS75 ± 5	Small85 ± 10
		S85 ± 5	Medium93 ± 10
		M95 ± 5	Large105 ± 10
		L105 ± 5	Extra Large115 ± 10
		XL115 ± 5	/
		Thickness (mm) For all sizes minFinger0.08	Thickness (mm) min	Similar
			SizePalmActual valueFingerActual value

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		Palm		0.08		Small	0.09			0.12
				/		Medium	0.09			0.12
				/		Large	0.10			0.13
			/		/		ExtraLarge	0.09			0.12
PhysicalProperties	ASTM D412S-2 AQL 4.0	Type I				Type I						Similar
			BeforeAging		AfterAcceleratedAging		Before Aging			After AcceleratedAging
		TensileStrength	$18\text{MPa, min}$		$14\text{ MPa, min}$	TensileStrength	Size	Actualvalue		Size	Actualvalue
							Small	18.04		Small	15.02
							Medium	19.13		Medium	18.12
							Large	18.26		Large	16.01
							ExtraLarge	18.64		ExtraLarge	15.06
		UltimateElongation	$650 % \text{ min}$		$500 % \text{ min}$	UltimateElongation	Size	Actualvalue		Size	Actualvalue
							Small	651		Small	501
							Medium	654		Medium	601
							Large	650		Large	501
							ExtraLarge	650		ExtraLarge	502
Freedom fromholes	ASTM D5151	No water leakage is inspected.I AQL 2.5			Pass AQL 2.5					SAME
Powder FreeResidue	ASTM D6124N=5Less than 2.0 mg/glove	Size			Residual powdercontent(mg/glove)	Size			Residual powdercontent(mg/glove)			Similar
		XS		0.28		Small			0.62
		S		0.25		Medium			0.46
		M		0.31		Large			0.61
		L		0.25		Extra Large		0.61
		XL		0.35		/			/
ProteinContent	ASTM D5712N=3Less than 200 µg/dm²	Less than 200 µg/dm²			Protein Content (µg/dm²)					Similar
					Size		Actual value
					Small		124.36
					Medium		140.78
					Large		134.26
					Extra Large		159.46
Cytotoxicity	ISO 10993-11The test article showed"negative" systemictoxicity				Under the conditions of the study, the testarticle showed "negative" systemic toxicity.	Non-cytotoxic					SAME
Irritation	ISO 10993-23The response of the testarticle has no skinirritation				Under the experimental conditions, the testarticle has no skin irritation on rabbits.	Non-irritating					SAME
Sensitization	ISO 10993-10The test article showedno evidence of causingdelayed dermal contactsensitization.				The test article showed no evidence of causingdelayed dermal contact sensitization in theguinea pig.	Non-sensitizing					SAME

9. Summary of Non-Clinical Testing

Bench tests were conducted to demonstrate that the proposed device complies with the following standards:

ISO 10993-10: 2021 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization.

ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ASTM D3578-19 Standard Specification for Rubber Examination Gloves

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Test Item	Test Method	Test Purpose/Description	Acceptance Criteria	Results
AcuteSystemicToxicityTest	Extraction Method	The test was designed toevaluate the potential acutesystem toxicity caused bytest article contact with theICRmiceandextrapolating the results tohumans.	ISO 10993-11Biological evaluation ofmedical devices - Part11: Tests for systemictoxicity.	The test articlehas no potentialacute systemtoxicity on ICRmice in theextractionmethod.
SkinIrritationTest	Extraction Method	To evaluate the potentialskin irritation caused bytest article contact with theskin surface of rabbits andextrapolating the results tohumans, but it does notestablish the actual risk ofirritation.	ISO 10993-23: 2021Biological evaluation ofmedical devices - Part23: Tests for irritation.	Under theexperimentalconditions, thetest article hasno skinirritation onrabbits.
SkinSensitizationTest	GuineaPigMaximization	The test was designed toevaluate the potential of atest article to cause skinsensitization. The test isused as a procedure forscreening of contactallergens in guinea pigsand extrapolating theresults to humans, but itdoes not establish theactual risk of sensitization.	ISO 10993-10: 2021Biological EvaluationOf Medical Devices -Part 10: Tests For SkinSensitization.	Under theexperimentalconditions, thetest article hasno potentialskinsensitization onguinea pigs inthe method.
PhysicalDimensionsTest	Use steel ruler andthe apparatus formeasurement ofthickness (0-10mm)to measure glovesPhysical dimensions.	The gloves shall complywith the dimensionrequirements prescribed inASTM D3578-19 Table 2.	Inspection Level: S-2AQL: 4.0	The subjectdevice complywith thedimensionrequirementsprescribed inASTM D3578-19.
PhysicalPropertyCharacteristics Test	Dumbbell andStraight SectionSpecimens.	Before andafter accelerated aging, thegloves shall conform to thephysical requirementsspecified in ASTMD3578-19 Table 3.	Inspection Level:AQL:	Before and afteracceleratedaging, thesubject deviceconform to thephysicalrequirementsspecified inASTM D3578-19 Table 3.
FreedomFrom HolesTest	Refer to the ASTMD 5151-06, StandardTest Method forDetection of Holes inMedical Gloves.	This test method is to thedetection of holes thatallow water leakage underthe conditions of the test.	Inspection Level: IAQL: 2.5	No waterleakage isinspected.The subjectdevice conformto therequirementsspecified inASTM D5151.
PowderedGlove Test	Refer to the ASTMD 6124-06, R2017,Standard TestMethod for ResidualPowder on MedicalGloves.	These test are thedetermination of averagepowder or filter-retainedmass found on a sample ofmedical gloves asdescribed in theintroduction.	Inspection Level: N=5Residual Powder lessthan 2 mg per glove.	ResidualPowder lessthan 2 mg perglove.The subjectdevice conformto therequirementsspecified inASTM D6124.
ExtractableProtein Test	Refer to the ASTMD5712 Standard TestMethod for Analysisof AqueousExtractable Proteinin Latex, NaturalRubber, andElastomeric ProductsUsing the ModifiedLowry Method.	The test was designed totest the laechable proteinof the test glove.	Inspection Level: N=3Less than 200 µg/dm².	The resultsshowed that theaverageExtractableProtein of testsamples wasmet theacceptancecriteria inASTM D5712.

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1. Summary of Clinical Testing Not applicable
1. Conclusions

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE, cleared under K210253.

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.