The Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) 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, Powder Free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) 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 Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Violet Blue, White, and Cobalt Blue.

The proposed device is not provided as sterilized

AI/ML Overview

This document is a 510(k) Pre-Market Notification for Powder free Nitrile Examination Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Performance and Physical Specifications" table (Table 2) on page 5, and the "Performance Comparison" table (Table 3) on pages 6-7, supported by non-clinical bench tests.

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

Acceptance Criteria (ASTM D6319-15)	Reported Device Performance (Powder free Nitrile Examination Gloves - Proposed Device)
Pinhole AQL	1.5
Before Aging
Tensile Strength	14 MPa, min
Ultimate Elongation	500 % min
After Aging
Tensile Strength	14 MPa, min
Ultimate Elongation	400 % min
Fulfill ASTM D6319	Comply with ASTM D6319
Freedom from Holes	Be free from holes when tested in accordance with ASTM D5151
Powder Content	Less than 2 mg per glove when tested in accordance with ASTM D6124
Biocompatibility
Irritation and Sensitization	Under the conditions of the study, not an irritant and not a sensitizer
Cytotoxicity	Under conditions of the study, not cytotoxic

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 explicitly state the sample size used for the test set for each specific test (e.g., tensile strength, pinholes). However, the testing was conducted according to recognized ASTM and ISO standards, which typically specify sampling plans. The data provenance is from non-clinical bench tests performed to verify the device's compliance with design specifications and relevant standards. The country of origin of the data is implied to be related to the manufacturer in Vietnam or the testing facilities they utilized. The studies are prospective as they were specifically conducted for this 510(k) submission.

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 this type of device and study. The "ground truth" for performance of examination gloves is established by quantitative measurements according to standardized test methods (ASTM and ISO standards), not by expert opinion.

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

Not applicable. As described above, performance is determined by objective measurements using standardized test methods.

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 device is an examination glove, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. This device is an examination glove, not an algorithm.

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

The "ground truth" for the performance of the examination gloves is based on established industry standards and test methods (ASTM D6319-15, ASTM D5151-06, ASTM D6124-17, ISO 10993-10:2010, ISO 10993-5:2009). These standards define the acceptable physical properties, barrier integrity, and biocompatibility of medical examination gloves.

8. The sample size for the training set

Not applicable. This device is an examination glove, not a machine learning model that requires a training set.

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

Not applicable. There is no training set for this device.

Summary

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March 2, 2021

Kanglongda Vietnam Protection Technology Company Limited % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District, Beijing 102401 China

Re: K202356

Trade/Device Name: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 1, 2021 Received: February 4, 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.

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

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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 (OS) 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 mediation-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, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K202356

Device Name

Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)

Indications for Use (Describe)

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

The assigned 510(k) Number: K202356

1. Date of Preparation: 01/29/2021
1. Sponsor

KANGLONGDA Vietnam Protection Technology Company Limited

Lot CN 05, Viglacera - Phong Dien Industrial Park, Phong Hoa Commune, Phong Dien District, Thua Thien Hue Province, Vietnam 535041 Contact Person: Lu Lingfeng Position: Manager Tel: +84 234 3888189 Fax: +84 234 3888189 Email: qa.vn@kanglongda.com.cn

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: Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) Common Name: NITRILE Patient Examination Gloves (Powder Free)

Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250

Product Name: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) Manufacturer: KANGLONGDA Vietnam Protection Technology Company Limited

Indication For Use Statement:

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Predicate Device Identification 5.
510(k) Number: K150340 Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250

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, Powder Free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) 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 Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Violet Blue, White, and Cobalt Blue.

The proposed device is not provided as sterilized

REF	CuffThickness( $\pm$ 0.01mm)	PalmThickness( $\pm$ 0.01mm)	FingerThickness( $\pm$ 0.01mm)	Length(mm)	Width(mm)	Color
KF30	0.05	0.06	0.08	$\ge$ 230	XS:70 $\pm$ 10	Blue /
KF35	0.06	0.07	0.09		S: 80 $\pm$ 10	Violet Blue /
KF40	0.06	0.08	0.11		M:95 $\pm$ 10	White /
KF45	0.07	0.09	0.12		L:110 $\pm$ 10	Cobalt Blue
KF50	0.07	0.09	0.13		XL:120 $\pm$ 10
KF55	0.08	0.10	0.14

Table 1 Device Size Specifications

Table 2 Performance and Physical Specifications

Before Aging		After Aging		Pinhole AQL
TensileStrength	UltimateElongation	TensileStrength	UltimateElongation	1.5
14 MPa, min	500 % min	14 MPa, min	400 % 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.

7. Technological Comparison Table

Table 1 General Comparison
ITEM	Proposed Device (K202356)	Predicate Device (K150340)	Remark
	Powder free Nitrile Examination Gloves(Blue, Violet Blue, White, Cobalt Blue)	POWDER FREE Nitrile GLOVES (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 (Blue, Violet Blue, White, CobaltBlue) is a disposable device intended formedical purposes that is worn on theexaminer's hands to prevent contaminationbetween patient 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
Powdered orPowered free	Powdered free	Powdered free	SAME

Table 1 General Comparison

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Proposed Device		Size
Powder free Nitrile Examination Gloves(Blue, Violet Blue, White, Cobalt Blue)	Designation	XS	S	M	L	XL	Tolerance
	Length, mm	230	230	230	230	230	min
	Width, mm	70	80	95	110	120	$\pm$ 10
		Thickness, mm:
		Finger	0.08-0.14				$\pm$ 0.01
		Palm	0.06-0.10				$\pm$ 0.01
		Cuff	0.05-0.08				$\pm$ 0.01
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	$\pm$ 10
		Thickness, mm:
		Finger	0.10-0.12				$\pm$ 0.03
		Palm	0.08-0.10				$\pm$ 0.03
		Cuff	0.06-0.09				$\pm$ 0.03

Table 2 Device Dimensions Comparison

Table 3 Performance Comparison

			Proposed Device	Predicate Device (K150340)
ITEM			Powder free Nitrile ExaminationGloves (Blue, Violet Blue, White,Cobalt Blue)	POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, IceBlue)	Remark
Colorant			Blue, Violet Blue, White, Cobalt Blue	White, Cobalt Blue, Black, Ice Blue	Different
PhysicalProperties	BeforeAging	TensileStrength	14 MPa, min	15 MPa, min	Similar
		UltimateElongation	500 % min	500 % min	SAME

	AfterAging	TensileStrength	14 MPa, min	14 MPa, min	SAME
		UltimateElongation	400 % min	400 % min	SAME

			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 tested	Meet the requirements of ASTM	SAME

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	in accordance with ASTM D6124	6319
--	-------------------------------	------

ITEM	Proposed Device	Predicate Device (K150340)	Remark
	Powder free Nitrile ExaminationGloves (Blue, Violet Blue, White,Cobalt Blue)	POWDER FREE Nitrile GLOVES(White, Cobalt Blue, Black, IceBlue)
Material	Nitrile	Nitrile	SAME
Biocompatibility	Irritation andSensitization	Under the conditions of the study,not an irritant and not a sensitizer	Under the conditions of the study,not an irritant and not a sensitizer.	SAME
	Cytotoxicity	Under conditions of the study, notcytotoxic.	N/A	Different
	Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	SAME

Table 4 Safety Comparison

8. Non-Clinical Test

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. Conclusion
  The conclusions drawn from the nonclinical test that the device is as safe, as effective, and performs as well as or better than the 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.