The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, \Vhite) 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 proposed device, NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) includes variations of different size and color. The colors of the proposed device are Blue, and White.

AI/ML Overview

The document describes the K202402 Nitrile Examination Gloves. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Standard)	Test Parameter	Proposed Device Performance (Minimum)	Predicate Device AQL (or value)
ASTM D6319-15	Pinhole AQL	1.5	N/A (implied 1.5 by ASTM)
	Tensile Strength (Before Aging)	15 MPa	15 MPa
	Ultimate Elongation (Before Aging)	500 %	500 %
	Tensile Strength (After Aging)	14 MPa	14 MPa
	Ultimate Elongation (After Aging)	500 %	400 %
ASTM D5151-06	Freedom from Holes	Free from holes	Free from holes
ASTM D6124-17	Powder Content	Less than 2 mg per glove	Meet ASTM D6319 requirements
ISO 10993-10:2010	Irritation	Not an irritant	Not an irritant
	Sensitization	Not a sensitizer	Not a sensitizer
ISO 10993-5:2009	In vitro cytotoxicity	N/A (implied non-cytotoxic)	N/A (implied non-cytotoxic)
Biocompatibility	Acute Systemic Toxicity	Not toxic (for proposed device)	Not Available (for predicate)
Physical (Dimensions)	Length (XS, S, M)	230 mm min	230 mm min
	Length (L, XL)	235 mm min	230 mm min
	Width	70, 80, 95, 110, 120 mm (±10 mm)	70, 80, 95, 110, 120 mm (±10 mm)
	Finger Thickness	0.05 mm min	0.10-0.12 mm (±0.03 mm)
	Palm Thickness	0.05 mm min	0.08-0.10 mm (±0.03 mm)
	Cuff Thickness	0.05 mm min	0.06-0.09 mm (±0.03 mm)

Note: The document explicitly states that "The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319." and that the bench tests "demonstrated that the proposed device complies with the following standards".

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

The document does not specify the exact sample sizes for each test that was performed. It generally refers to "bench tests" for physical properties and "biocompatibility tests".

Provenance: No specific country of origin is mentioned for the test data itself, beyond the manufacturer being in China. The study is non-clinical bench testing, not human data.

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

Not applicable. This is a medical glove, and the "ground truth" for its performance is established by adherence to recognized international standards (ASTM, ISO) through objective physical and biocompatibility testing, not expert consensus on interpretations of complex medical images or outcomes.

4. Adjudication method for the test set

Not applicable, as the tests are objective measurements against standards.

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

Not applicable. This is a medical glove, not an AI-powered diagnostic device.

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

Not applicable. This is a medical glove, not an algorithm.

7. The type of ground truth used

The ground truth used for performance evaluation is defined by international consensus standards for medical gloves (ASTM D6319-15, ASTM D5151-06, ASTM D6124-17) and biocompatibility testing standards (ISO 10993-10:2010, ISO 10993-5:2009). The device is tested against the specified parameters and thresholds outlined in these standards.

8. The sample size for the training set

Not applicable. This is a physical medical device (gloves), not an AI algorithm requiring a training set.

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

Not applicable. This is a physical medical device (gloves), not an AI algorithm.

Summary

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March 1, 2021

Jiangsu Tianshuo Medical Products 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, Beijing 102401 China

Re: K202402

Trade/Device Name: Nitrile Examination Gloves (Blue, Violet Blue, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 28, 2021 Received: February 1, 2021

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.

Ryan Ortega, PhD Acting Assistant Director CDHT4B: 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved : 0MB No. 0910-0120 Expiration Date:06/30/2023 See PRA Statement below.

510(k) Number (if known) K202402

Device Name

NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White)

Indications for Use (Describe)

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

D Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K202402

1. Date of Preparation: 08/19/2020
1. Sponsor

Jiangsu Tianshuo Medical Products Co., Ltd.

No. 78, North Longjin Road, Sucheng Economic Development Area, Suqian City, Jiangsu Province, China Contact Person: Gao Feng Position: Business Manager Tel: +86-15203225200 Fax: +86-312-5790666 Email: 1243524269@qq.com

Submission Correspondent 3.
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com

Proposed Device Identification 4.
Trade Name: NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) Common Name: NITRILE Patient Examination Gloves (Powder Free)

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

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Indication For Use Statement:

The NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

1. Predicate Device Identification
  510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD
1. Device Description
  The proposed device, NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are NITRILE EXAMINATION GLOVES (Blue, Violet Blue, White) includes variations of different size and color. The colors of the proposed device are Blue, and White.

Designation	SIZE					Tolerance
	XS	S	M	L	XL
Length (mm)	230	230	230	235	235	Min.
Width (mm)	70	80	95	110	120	±10 (mm)
Thickness (mm)
Finger	0.05					Min.
Palm	0.05					Min.
Cuff	0.05					Min.

Table 1 Device Size Specifications

Before Aging		After Aging		Pinhole AQL
Tensile Strength	Ultimate Elongation	Tensile Strength	Ultimate Elongation	1.5
15 MPa, min	500 % min	14 MPa, min	500 % min

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The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.

1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D6319-15, Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves. 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.

1. Technology Comparison Table

	Proposed Device (K202402)	Predicate Device (K150340)
ITEM	NITRILE EXAMINATION GLOVES	POWDER FREE Nitrile GLOVES (White,	Remark
	(Blue, Violet Blue, White)	Cobalt Blue, Black, Ice Blue)
Product Code	LZA	LZA	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	SAME
Intended Use	The Powder free Nitrile ExaminationGloves NITRILE EXAMINATIONGLOVES (Blue, Violet Blue, White) is adisposable device intended for medicalpurposes that is worn on the examiner'shands to prevent contamination betweenpatient and examiner.	The POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, Ice Blue) is adisposable device intended for medicalpurposes that is worn on the examiner'shands to prevent contamination betweenpatient and examiner.	SAME
Powered free	Powdered free	Powdered free	SAME

Table 3 General Comparison

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		Size
Proposed Device	Designation	XS	S	M	L	XL	Tolerance
NITRILE EXAMINATION GLOVES(Blue, Violet Blue, White)	Length, mm	230	230	230	235	235	min
	Width, mm	70	80	95	110	120	±10
	Thickness, mm:
	Finger	0.05					Min.
	Palm	0.05					Min.
	Cuff	0.05					Min.
Predicate Device (K150340)		Size
POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, Ice Blue)	Designation	XS	S	M	L	XL	Tolerance
	Length, mm	230	230	230	230	230	min
	Width, mm	70	80	95	110	120	±10
	Thickness, mm:
	Finger	0.10-0.12					±0.03
	Palm	0.08-0.10					±0.03
	Cuff	0.06-0.09					±0.03

Table 4 Device Dimensions Comparison

Table 5 Performance Comparison

ITEM	Proposed DeviceNITRILE EXAMINATION GLOVES(Blue, Violet Blue, White)	Predicate Device (K150340)POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, Ice Blue)	Remark
Colorant	Blue, Violet Blue, White	White, Cobalt Blue, Black, Ice Blue	Similar
PhysicalProperties	Before Aging
	Tensile Strength	15 MPa, min	15 MPa, min	SAME
	Ultimate Elongation	500 % min	500 % min	SAME
	After Aging
	Tensile Strength	14 MPa, min	14 MPa, min	SAME
	Ultimate	500 % min	400 % min	Similar

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	Elongation
	Comply with ASTM D6319	Comply with ASTM D6319	SAME
Freedom from Holes	Be free from holes when tested inaccordance with ASTM D5151	Be free from holes when tested inaccordance with ASTM D5151	SAME

Powder Content	Less than 2 mg per glove when testedin accordance with ASTM D6124	Meet the requirements of ASTM6319	SAME

The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-10 and ISO 10993-5, the test results showed that the proposed devices with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization.

The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.

ITEM	Proposed Device(K202402)	Predicate Device (K150340)	Remark
	NITRILEEXAMINATIONGLOVES (Blue, Violet Blue, White)	POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, Ice Blue)
Material	Nitrile	Nitrile	SAME
Biocompatibility	Irritation	Under the conditions of the study,not an irritant	Under the conditions of the study,not an irritant	SAME
	Sensitization	Under conditions of the study, not asensitizer.	Under conditions of the study, not asensitizer.
	AcuteSystemicToxicity	Under conditions of the study, nottoxic	Not Available

Table 6 Safety Comparison

9. Conclusion

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