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 examination gloves, adding 1%-3% nitrile to improve the tensile strength and ultimate elongation. The subject device is blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Synthetic Nitrile Examination Gloves. It details the device's characteristics, its intended use, and comparative testing against a predicate device to establish substantial equivalence.

Based on the document, I can provide the acceptance criteria and study details for the device as follows:

Acceptance Criteria and Device Performance

The acceptance criteria for the Synthetic Nitrile Examination Gloves are primarily based on performance standards and biocompatibility. The reported device performance is compared against these criteria.

Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance	Result
ASTM D5250	Physical Dimensions Test - Length	$\ge$ 230 mm	> 240 mm	Pass
ASTM D5250	Physical Dimensions Test - Width (S)	85 ± 5 mm	87-88 mm	Pass
ASTM D5250	Physical Dimensions Test - Width (M)	95 ± 5 mm	96-98 mm	Pass
ASTM D5250	Physical Dimensions Test - Width (L)	105 ± 5 mm	105-107 mm	Pass
ASTM D5250	Physical Dimensions Test - Width (XL)	115 ± 5 mm	116 mm	Pass
ASTM D5250	Physical Dimensions Test - Thickness (Finger)	$\ge$ 0.08 mm	0.12-0.13 mm	Pass
ASTM D5250	Physical Dimensions Test - Thickness (Palm)	$\ge$ 0.08 mm	0.08-0.09 mm	Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125 (implies 0 defects in 125 samples, meeting AQL 2.5 criteria)	Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 ($<$ 2.0 mg)	0.14 mg	Pass
ASTM D412	Physical properties - Before Aging (Tensile Strength)	$\ge$ 11 MPa	14-22 MPa	Pass
ASTM D412	Physical properties - Before Aging (Ultimate Elongation)	$\ge$ 300%	424-509%	Pass
ASTM D412	Physical properties - After Aging (Tensile Strength)	$\ge$ 11 MPa	13.4-19 MPa	Pass
ASTM D412	Physical properties - After Aging (Ultimate Elongation)	$\ge$ 300%	357-493%	Pass
ISO 10993-11	Cytotoxicity	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo.	Pass
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study, not an irritant.	Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer.	Pass

Study Details Proving Device Meets Acceptance Criteria

The document focuses on non-clinical testing for the device's physical properties and biocompatibility.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document explicitly mentions a sample size of 125 for the "Watertightness Test for Detection of Holes" (0/125). For other tests (Dimensions, Powder Content, Physical Properties, Biocompatibility), specific sample sizes are not detailed in the provided tables, but general industry standards for these tests typically involve a statistically significant number of samples from production lots.
- Data Provenance: The manufacturing site is Shandong Hongxin Chemicals Co.,Ltd. in Zibo City, Shandong Province, China. The official correspondent is Shanghai Truthful Information Technology Co., Ltd. also in China. Therefore, the data provenance is from China, and the studies are retrospective as they were conducted to obtain premarket clearance for existing device designs.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This section is not applicable to this type of device and study. The testing for examination gloves involves objective physical and chemical measurements (e.g., tensile strength, dimensions, freedom from holes, biocompatibility tests). These are not expert-derived "ground truth" in the way an AI diagnostic algorithm for medical images would require radiologists for ground truth labeling. The "ground truth" is defined by the established and published ASTM and ISO standards themselves.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are typically used in studies involving subjective expert interpretation, such as medical image reading or clinical diagnoses where there might be inter-reader variability. For the physical and chemical testing of medical gloves, the results are objective measurements against defined standards, not subject to expert adjudication.
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:
- No. An MRMC study is relevant for AI-assisted diagnostic devices that involve human readers. This device is a physical medical product (examination gloves), not an AI algorithm for diagnosis, so an MRMC study was not performed and is not applicable.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is a physical medical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
The Type of Ground Truth Used:
- The "ground truth" for this device's performance testing is based on established international consensus standards (ASTM and ISO). These standards define the physical, mechanical, and biological properties a patient examination glove must meet for its intended use. For example:
  - Physical/Mechanical Properties: ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412.
  - Biocompatibility: ISO 10993-10, ISO 10993-11.
- The ground truth is not derived from expert consensus on individual cases, pathology, or outcomes data in the way it would be for a diagnostic tool.
The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not a machine learning model or AI algorithm that requires a "training set." The device is manufactured and then tested against established performance standards.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for physical examination gloves. The manufacturing process is controlled via quality systems (e.g., 21 CFR Part 820 for QMSR) and tested to ensure conformity to the established standards as outlined in point 6.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

November 26, 2021

Shandong Hongxin Chemicals Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China

Re: K212488

Trade/Device Name: Synthetic Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: October 18, 2021 Received: October 29, 2021

Dear Mr. 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.

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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 and Part 809); 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.

Clarence W. Murray, III, PhD 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) K212488

Device Name Synthetic Nitrile 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)
-------------------------------------------------

	Registration Use (Part 21 CFR 201.66) Select One		Service Use Correction (21 CFR 201.66) Select One
-------------	--------------------------------------------------	-------------	---------------------------------------------------

__ 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 (K212448)

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

1.0 Submitter's Information

Name: Shandong Hongxin Chemicals Co.,Ltd. Address: No.10161, Xinhua Road, Zhoucun District, Zibo City, Shandong Province, China 255300 Tel: +86-15550323002 Contact: Ping Wang

Designated Submission Correspondent

Name: Shanghai Truthful Information Technology Co., Ltd. Address: Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Contact: Mr. Boyle Wang Email: Info@truthful.com.cn

Date of Preparation: Oct.18th,2021

2.0 Device Information

Trade name: Synthetic Nitrile Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I General Hospital Panel:

3.0 Predicate Device Information

Manufacturer: Zibo Huiying Medical Products, Co. Ltd. Synmax Synthetic Patient Examination Vinyl Gloves,Powder Free,Blue Device: 510(k) number: K153028

4.0 Indication for Use

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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.

5.0 Device Description

6.0 Technological Characteristic Comparison Table

Item	Subject Device(K212448)	Predicate Device(K153028)
Product Code	LZA	LZA
Regulation No.	21CFR880.6250	21CFR880.6250
Class	I	I
Intended 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.	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.
Material	Poly Vinyl ChloridePolyurethaneNitrileDi-(2-ethylhexyl)Terephthalate(DOTP)	Poly Vinyl ChloridePolyurethaneDiisononyl Phthalate (DINP)
Powdered orPowered free	Powdered free	Powdered free
Design Feature	Ambidextrous	Ambidextrous
Colorant	Blue	Blue
Labeling Information	Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile	Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile
Dimensions(mm)	Length:≥230;Width:	Length:Average over 234 on M size;Width:

Table1-General Comparison

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S: 85±5;M: 95±5;L: 105±5;XL: 115±5	Average over 96 on M size
Thickness(mm)	Finger: ≥0.08;Palm: ≥0.08	Finger: Average 0.98;Palm: Average 0.096
PhysicalProperties	BeforeAging	TensileStrength	11MPa, min	TensileStrength	Average 16.9MPa
		UltimateElongation	300% min	UltimateElongation	Average 550%
	AfterAging	TensileStrength	11MPa, min	TensileStrength	Average 14.4MPa
		UltimateElongation	300%min	UltimateElongation	Average 500%
Freedom fromHoles	Be free from holes when tested in accordance withASTMD5151 AQL=2.5		Be free from holes when tested in accordance withASTMD5151 AQL=2.5
Powder Content	Meet the requirements ofASTM D6124		Meet the requirements ofASTM D6124
Biocompatibility	ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer		ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer
	ISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.		/
	ISO 10993-5Under conditions of thestudy, device extract iscytotoxic		/

7.0 Summary 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.

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ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests

for systemic toxicity.

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

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

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

TestMethod	Purpose	Acceptance Criteria	Results
ASTMD5250	PhysicalDimensionsTest	Length(mm):$\ge$ 230;	Length:> 240/Pass;
		Width(mm):S: 85±5;M: 95±5;L: 105±5;XL: 115±5	Width:S: 87-88 /PassM: 96-98/ PassL: 105-107/ PassXL:116/Pass
		Thickness (mm):
		Finger: $\ge$ 0.08	Finger: 0.12-0.13/Pass
		Palm: $\ge$ 0.08	Palm: 0.08-0.09/Pass
ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/125/Pass
ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 <2.0mg	0.14mg/Pass;
ASTMD412	Physicalproperties	BeforeAgingTensileStrength	$\ge$ 11MPa	14 -22/Pass;
		UltimateElongation	$\ge$ 300%	424-509/Pass;
		AfterAgingTensileStrength	$\ge$ 11MPa	13.4-19/Pass;
		UltimateElongation	$\ge$ 300%	357-493/Pass;
ISO10993-11	Cytotoxicity	Non- acute systemictoxicity	Under conditions ofthe study, did not
			show acute systemic
			toxicity in vivo / Pass
ISO10993-10	Irritation	Non-irritating	Under the conditionsof the study, not anirritant/ Pass
ISO10993-10	Sensitization	Non-sensitizing	Under conditions ofthe study, not asensitizer./ Pass

Table 2 - Summary of non-clinical performance testing

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8.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

9.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Synthetic Nitrile Examination Gloves, 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.