The Powder Free Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The subject device is powder free vinyl patient examination gloves. The subject device is colorless. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

AI/ML Overview

This document describes the premarket notification for the "Powder Free Vinyl Patient Examination Glove" (K210799). It is a Class I device and the submission focuses on demonstrating substantial equivalence to a predicate device (K163168).

Here's an analysis of the acceptance criteria and study data:

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

The acceptance criteria are implicitly defined by compliance with specific ASTM and ISO standards, and by showing equivalence to the predicate device, particularly regarding physical properties and biocompatibility.

Acceptance Criteria (Standard/Requirement)	Reported Device Performance (Subject Device)
Physical Dimensions:
Length (ASTM D5250)	230mm (XS, S, M, L, XL) min
Width (ASTM D5250)	75mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) $\pm$ 5mm
Finger Thickness (ASTM D5250)	0.08mm min
Palm Thickness (ASTM D5250)	0.08mm min
Physical Properties:
Tensile Strength Before Aging (ASTM D5250)	11MPa, min
Ultimate Elongation Before Aging (ASTM D5250)	300% min
Tensile Strength After Aging (ASTM D5250)	11MPa, min
Ultimate Elongation After Aging (ASTM D5250)	300% min
Freedom from Holes (ASTM D5151)	Be free from holes when tested in accordance with ASTM D5151, AQL=2.5
Powder Content (ASTM D6124)	< 0.02 mg per glove
Biocompatibility:
Irritation (ISO 10993-10)	Under the conditions of the study, not an irritant
Sensitization (ISO 10993-10)	Under conditions of the study, not a sensitizer.
Cytotoxicity (ISO 10993-5)	Under conditions of the study, did not show potential toxicity to L-929 cells.
Labeling	Meets FDA's Requirement (Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile information stated)
Material	Vinyl
Intended Use	Disposable device for medical purposes, worn on examiner's hands to prevent contamination between patient and examiner.

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for tensile strength, pinholes, etc.). It only references compliance with the standards, which typically define sampling plans. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the manufacturer's location in China, it is highly probable that the testing was conducted in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert human interpretation of medical data (like radiology images).

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in expert-dependent diagnostic studies, not for the physical and biological testing of medical devices like gloves.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools, not for medical gloves. The device is not an AI-assisted tool.

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

A standalone performance study was not applicable/conducted in the context of an algorithm or AI. The performance studies conducted were on the physical and biological properties of the glove itself.

7. The type of ground truth used

The "ground truth" for this device's performance is established by compliance with recognized industry standards and regulatory requirements. This includes:

Engineering Standards: ASTM D5250 (Standard Specification for Poly (vinyl chloride) Gloves for Medical Application), ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves).
Biocompatibility Standards: ISO 10993-10 (Tests For Irritation And Skin Sensitization), ISO 10993-5 (Tests For In Vitro Cytotoxicity).
Predicate Device Equivalence: Demonstrating that the subject device performs similarly or better than a legally marketed predicate device (K163168) in key functional and safety attributes.

8. The sample size for the training set

This information is not applicable. The device is a physical product (medical glove), not an AI algorithm requiring a training set.

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

This information is not applicable. As explained above, there is no AI algorithm or training set for this device.

Summary

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May 14, 2021

Yunnan Huazhiyuan Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210799

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: March 17, 2021 Received: March 22, 2021

Dear Boyle 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.

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

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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,

For Ryan Ortega, Ph. D Acting 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) K210799

Device Name Powder Free Vinyl Patient Examination Glove

Indications for Use (Describe)

The Powder Free Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)
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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 (K210799)

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

Yunnan Huazhiyuan Medical Technology Co., Ltd. Name: Address: Yangjie Industrial Park,Jianshui County,Honghe Hani and Yi Autonomous Prefecture, Yunnan Province,China Phone Number: +86-18252909158 Contact: Yun Gao Date of Preparation: May.12,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Powder Free Vinyl Patient Examination Glove Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove Model(s): XS、S、M、L、XL

3.0 Classification

Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: Hebei Hongtai Plastic Products Company Limited Vinyl Patient Examination Gloves (White, Blue, Yellow) Device: 510(k) number: K163168

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5.0 Indication for Use

The Powder Free Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

6.0 Device Description

7.0 Technological Characteristic Comparison Table

Item	Subject device	Predicate device	Comparison
510(k) number	K210799	K163168	Different
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	Powder Free VinylPatient ExaminationGlove is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	The Vinyl ExaminationGlove (White, Blue, orYellow) is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner.	Same
Powdered orPowered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
LabelingInformation	Single use, powder free,device color, devicename, glove size andquantity, VinylExamination Gloves,Non-Sterile	Single use, powder free,device color, devicename, glove size andquantity, VinylExamination Gloves,Non-Sterile	Similar

Table1-General Comparison

Table2 Device Dimensions Comparison

Predicate Device(K163168)	Designation	Size					Tolerance
		XS	S	M	L	XL

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	Length, mm	230	230	235	245	245	min
	Width, mm	80	85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Subject Device	Designation	Size					Tolerance
		XS	S	M	L	XL
	Length, mm	230	230	230	230	230	min
	Width, mm	75	85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.08					min
	Palm	0.08					min
Remark	Similar

Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250,so the differences do not raise any new safety or performance questions.

Item	Subject device	Predicate device	Comparison
Colorant	Clear	White, Blue,Yellow	Same
PhysicalProperties	Before Aging	TensileStrength	11MPa, min	15MPa, min	Different
		UltimateElongation	300%min	380%min	Different
	After Aging	TensileStrength	11MPa, min	15MPa, min	Different
		UltimateElongation	300%min	380%min	Different
	Comply with ASTM D5250		Comply withASTM D5250	Same
Freedom from Holes	Be free from holes whentested in accordance withASTM D5151AQL=2.5		Be free from holeswhen tested inaccordance withASTM D5151AQL=2.5	Same
Powder Content	< 0.02 mg perglove	Meet therequirements ofASTM D6124	Similar

Table3 Performance Comparison

Analysis: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250,so the differences do not raise any new safety or performance questions.

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Item		Subject device	Predicate device	Comparison
Material		Vinyl	Vinyl	Same
Biocompatibility	Irritation	Under theconditions of thestudy, not an irritant	Comply withISO10993-10	Same
	Sensitization	Under conditions ofthe study, not asensitizer.
	Cytotoxicity	Under conditions ofthe study, did notshow potentialtoxicity to L-929cells.	Not provided	Different
Label and Labeling		Meet FDA'sRequirement	Meet FDA'sRequirement	Same

Table4 Safety Comparison

8.0 Discussion of Non-clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

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

ASTMD5151-19 Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

9.0 Clinical Test Conclusion

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the

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proposed 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.