A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

Device Description

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for Disposable Synthetic Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing against established standards. There is no information in this document about a study conducted to "prove the device meets acceptance criteria" in the way one might describe a clinical trial for a diagnostic algorithm or a comparative effectiveness study. This document is a regulatory submission for a Class I medical device (examination gloves), which have different evaluation requirements than, for example, AI-powered diagnostic software.

Therefore, many of the specific questions about "acceptance criteria," "device performance," "sample size for test set," "ground truth," "MRMC," and "standalone performance" are not applicable in the context of this document. This document details how the device meets regulatory and standard requirements, not how it performs in a diagnostic or clinical efficacy study.

However, I can extract the relevant information regarding the performance characteristics and safety evaluations presented in the document, framed as how the device demonstrates substantial equivalence and meets referenced standards.

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

For examination gloves, "acceptance criteria" are typically defined by recognized consensus standards which specify physical properties, freedom from holes, and biocompatibility. The "reported device performance" refers to the results of tests conducted to ensure the device meets these standards.

Acceptance Criteria (from referenced ASTM/ISO Standards)	Reported Device Performance (K210520)
Physical Properties (per ASTM D5250)
- Tensile Strength (Before Aging): 11MPa, min	Average 16.9MPa (subject device)
- Ultimate Elongation (Before Aging): 300% min	Average 550% (subject device)
- Tensile Strength (After Aging): 11MPa, min	Average 14.4MPa, min (subject device)
- Ultimate Elongation (After Aging): 300% min	Average 500% (subject device)
- Overall compliance with ASTM D5250 for physical properties	Complies with ASTM D5250
Freedom from Holes (per ASTM D5151)
- Be free from holes when tested in accordance with ASTM D5151, AQL=2.5	Be free from holes when tested in accordance with ASTM D5151, AQL=2.5
Powder Content (per ASTM D6124)
- Meet the requirements of ASTM D6124	0.01 mg per glove, Meet the requirements of ASTM D6124 (subject device)
Biocompatibility (per ISO 10993-10 and ISO 10993-5)
- Irritation: Not an irritant	Under the conditions of the study, not an irritant (subject device)
- Sensitization: Not a sensitizer	Under conditions of the study, not a sensitizer (subject device)
- Cytotoxicity: No potential toxicity to L-929 cells	Under conditions of the study, did not show potential toxicity to L-929 cells (subject device)
Device Dimensions (per ASTM D5250 requirements for length, width, thickness)
- Length, mm: 230 min	Length range: 230 mm (S, M, L, XL)
- Width, mm: Specific ranges for S, M, L, XL with ±5 tolerance	Width ranges: S (85mm), M (95mm), L (105mm), XL (115mm) with ±5 tolerance
- Thickness, mm: Finger 0.08 min; Palm 0.08 min	Thickness: Finger 0.08 min; Palm 0.08 min

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for tensile strength or holes). It references compliance with standards like ASTM D5151, which would imply specific sampling plans are followed within those standards. The data provenance is implied to be from the manufacturer, Shandong Shengshixincheng Medical Science & Technology Co., Ltd. (China), which conducted the tests to verify design specifications. The nature of these tests is prospective for the submission, meaning they were performed specifically to support the 510(k).

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 is not applicable. For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards (e.g., tensile strength, barrier integrity, biocompatibility), not by expert consensus on clinical images or diagnoses. The testing is objective and quantitative, performed in a lab setting.

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

This is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/imaging studies where interpretations can vary. Non-clinical tests for gloves involve standardized laboratory procedures with measurable outcomes.

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 not applicable. MRMC studies and AI assistance are relevant for diagnostic or interpretive devices; this document concerns examination gloves.

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

This is not applicable. This device is a physical product (gloves), not a software algorithm.

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

The "ground truth" in this context is defined by the objective performance criteria specified in international consensus standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10, ISO 10993-5). Successful compliance with these measured physical/chemical/biological properties constitutes the "ground truth" for showing the device is safe and effective as examination gloves.

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical device like examination gloves in the way it applies to machine learning algorithms.

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

This is not applicable. There is no "training set" for this type of device.

Summary

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May 26, 2021

Shandong Shengshixincheng Medical Science & Technology Co., % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K210520

Trade/Device Name: Disposable Synthetic Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 15, 2021 Received: April 19, 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 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210520

Device Name Disposable Synthetic Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands 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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510(k) Summary (K210520)

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

1.0 Submitter's Information

Shandong Shengshixincheng Medical Science & Technology Co., Ltd. Name: Address: No.28 Aluminum Deep Processing Industrial Park, Changshan Town,Zouping, Binzhou,Shandong Province, China. Phone Number: +86-15550323002 Contact: Ping Wang Date of Preparation: 04/15/2021

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: Disposable Synthetic Examination Gloves Vinyl Patient Examination Glove Common name: Classification name: Non-powdered Patient Examination Glove Model(s): 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: Zibo Huiying Medical Products, Co. Ltd. Device: Synmax Synthetic Patient Examination Vinyl Gloves,Powder Free,Blue 510(k) number: K153028

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5.0 Indication for Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

6.0 Device Description

7.0 Technological Characteristic Comparison Table

Item	Subject device	Predicated device	Comparison
510(k) number	K210520	K153028	/
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	A patient examinationglove is a disposabledevice intended formedical purposes that isworn upon theexaminer's hands toprevent contaminationbetween patient andexaminer.	A patient examinationglove is a disposabledevice intended formedical purposes thatis worn upon theexaminer's hands orfingers to preventcontamination betweenpatient and examiner.	Same
Powdered or Powered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Labeling Information	Single use, powder free,device color, devicename, glove size andquantity, product name,Non-Sterile	Single use, powderfree, device color,device name, glovesize and quantity,product name, Non-Sterile	Similar

Table1-General Comparison

Table2 Device Dimensions Comparison

PredicateDevice(K153028)	Designation	Size	Tolerance
	Length, mm	Average over 234 on M size	-

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	Width, mm	Average over 96 on M size
	Thickness, mm:
	Finger	Average 0.098		-
	Palm	Average 0.096		-
Subject	Designation	Size		Tolerance
Device(K210520)		S	M	L	XL
	Length, mm	230	230	230	230	min
	Width, mm	85	95	105	115	±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(K210520)	Predicated device(K153028)	Comparison
Colorant		Blue	Blue	Same
PhysicalProperties	BeforeAging	TensileStrength	11MPa, min	Average 16.9MPa	Analysis
		UltimateElongation	300%min	Average 550%	Analysis
	AfterAging	TensileStrength	11MPa, min	Average 14.4MPa, min	Analysis
		UltimateElongation	300%min	Average 500%	Analysis
		Comply with ASTM D5250		Same
Freedom from Holes		Be free from holes whentested inaccordance withASTM D5151AQL=2.5	Be free from holes whentested in accordance withASTM D5151 AQL=2.5	Same
Powder Content		0.01 mg per glove,Meet therequirements ofASTM D6124	Meet the requirements 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.

Table4 Safety Comparison

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Item		Subject device(K210520)	Predicated device(K153028)	Comparison
Material		Poly Vinyl ChloridePolyurethaneNitrileDi-(2-ethylhexyl)Terephthalate(DOTP)	Poly Vinyl ChloridePolyurethaneDiisononyl Phthalate(DINP)	Similar
Biocompatibility	Irritation	Under the conditions of thestudy, not an irritant	Comply withISO10993-10	SAME
	Sensitization	Under conditions of thestudy, not a sensitizer.
	Cytotoxicity	Under conditions of thestudy, did not show potentialtoxicity to L-929 cells.	/	Different
Label and Labeling		Meet FDA's Requirement	Meet FDA'S Requirement	SAME

Analysis: The materials of the subject device are little different with that of the predicate, but they all meet the performance requirements of ASTM D5250,also biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards. Therefore, the differences will not raise any safety and effectiveness issues on performance and biocompatibility.

8.0 Discussion of Non-clinical and Clinical Test Performed

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.

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10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K153028.

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.