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. lt can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for NBR Synthetic Examination Gloves, indicating that it is a Class I medical device (non-powdered patient examination glove). The purpose of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove de novo a device's safety and effectiveness through extensive clinical trials for new technologies.

As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing and biocompatibility assessments performed to demonstrate that the new device meets established standards for patient examination gloves and is substantially equivalent to a predicate device. There is no AI or diagnostic component to this device, so many of the common questions related to AI/ML device studies (e.g., ground truth, MRMC studies, training sizes) are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized standards for medical gloves (e.g., ASTM, ISO). The reported device performance indicates compliance with these standards.

Table of Acceptance Criteria and Reported Device Performance:

Test Method	Purpose	Acceptance Criteria	Reported Device Performance	Result
ASTM D5250: Physical Dimensions Test
Length (mm)	Length	$\ge$ 230	> 240	Pass
Width (mm)	Width	S: 85±5; M: 95±5; L: 105±5; XL: 115±5	S: 86-89; M: 95-97; L: 106-108; XL: 115-117	Pass
Thickness (mm)	Thickness	Finger: $\ge$ 0.08; Palm: $\ge$ 0.08	Finger: 0.08-0.16; Palm: 0.08-0.13	Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125	Pass
ASTM D6124	Residual Powder Content	Meet the requirements of ASTM D6124 < 2.0mg	0.12mg	Pass
ASTM D412: Physical Properties (Tensile Strength & Ultimate Elongation)
Before Aging: Tensile Strength	Tensile Strength	$\ge$ 11MPa	11 - 18MPa	Pass
Before Aging: Ultimate Elongation	Ultimate Elongation	$\ge$ 300%	340 - 518%	Pass
After Aging: Tensile Strength	Tensile Strength	$\ge$ 11MPa	11 - 16MPa	Pass
After Aging: Ultimate Elongation	Ultimate Elongation	$\ge$ 300%	315 - 438%	Pass
ISO 10993-11	Acute Systemic Toxicity	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 Information (as requested, with noted applicability)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the watertightness test (ASTM D5151), a sample size of 125 gloves was tested (0/125 indicates no holes found). Other physical and chemical tests would have their own sample sizes as per the respective ASTM/ISO standards, which are not explicitly detailed but are inherent to the "Pass" results.
- Data Provenance: The document does not specify the country of origin for the non-clinical testing data, but the submitter is based in China. The testing would be retrospective, as it involves laboratory tests on manufactured samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a patient examination glove and the evaluation relies on direct physical/chemical testing against established industry standards (ASTM, ISO), not on expert subjective interpretation or "ground truth" derived from human experts in a clinical context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical or reading studies where multiple readers interpret data. The tests performed are objective, laboratory-based measurements.
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:
- Not applicable. This device is a physical glove, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This does not relate to an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is defined by the objective, quantitative specifications and performance requirements outlined in the referenced international (ISO) and national (ASTM) standards for patient examination gloves. For example, "watertightness" is determined by a specific test procedure in ASTM D5151, not by expert consensus or pathology.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, and therefore no "training set" in that sense. The training/development of the manufacturing process would be internal to the company, but not part of a regulatory "training set" evaluation.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI/ML training set.

Summary

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December 23, 2021

Shandong Langtai International Trade 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: K212436

Trade/Device Name: NBR 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: October 18, 2021 Received: October 29, 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,

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) K212436

Device Name NBR 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)
Residential Use (Per 441.030 MAI Statute): Primary Residence
Rent-Free Occupation (Per 441.030 MAI Statute): Secondary Residence

__ 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 (K212436)

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

1.0 Submitter's Information

SHANDONG LANGTAI INTERNATIONAL TRADE CO.,LTD. Name: Address: 8/F,office Building,Weigiao Aluminum Deep,Processing Industrial Park ,ChanshanTown,Zouping,Binzhou City, Shandong, China 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: Dec.21st,2021

2.0 Device Information

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

3.0 Predicate Device Information

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

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

Table1-General Comparison
Item	Subject Device(K212436)	Predicate Device(K153028)
Product Code	LYZ	LYZ
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 ChloridePolyurethaneDi-(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
			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 asensitizerISO 10993-11;Under the condition of acutesystemic toxicity test, the test /article did not show acutesystemic toxicity in vivo.ISO 10993-5;Under conditions of thestudy, device extract iscytotoxic		ISO 10993-10;Under the conditions of thestudy, not an irritant or asensitizer

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.

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

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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: 86-89 /PassM: 95-97/ PassL: 106-108/ PassXL:115-117/ Pass
		Thickness (mm):Finger: $\ge$ 0.08Palm: $\ge$ 0.08	Finger: 0.08-0.16/PassPalm: 0.08-0.13/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	0.12mg/Pass;
ASTMD412	Physicalproperties	BeforeAging	TensileStrength	$\ge$ 11MPa	11 -18/Pass;
			UltimateElongation	$\ge$ 300%	340-518/Pass;
		AfterAging	TensileStrength	$\ge$ 11MPa	11-16/Pass;
			UltimateElongation	$\ge$ 300%	315-438/Pass;
ISO10993-11	Acute SystemicToxicity	Non- acute systemictoxicity		Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass

Table 2 - Summary of non-clinical performance testing

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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

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 NBR Synthetic 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.