Nitrile Examination Gloves (Blue, Violet Blue, White)

• K Number: K202402
• Device Name: Nitrile Examination Gloves (Blue, Violet Blue, White)
• Manufacturer: Jiangsu Tianshuo Medical Products Co., Ltd.
• Date Cleared: 2021-03-01 ( 192 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

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.

Predicate Devices

K150340

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.

Therapeutic

No
The device prevents contamination between patient and examiner, which is a protective function rather than a therapeutic one. Therapeutic devices are typically used to treat or cure a disease or condition.

Diagnostic

No

Explanation: The device is a glove, which is used for contamination prevention rather than diagnosing any condition or disease. Its purpose is protective, not analytical.

SaMD (Software as a Medical Device)

No

The device is described as physical nitrile examination gloves, which are hardware, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the gloves are "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
• Device Description: The description reinforces the barrier function and mentions variations in size and color, which are not characteristics of an IVD.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health status.
• Performance Studies: The performance studies focus on physical properties (tensile strength, elongation, pinhole AQL) and biocompatibility (irritation, sensitization), which are relevant to a barrier device, not an IVD.
• Key Metrics: The key metrics are also related to the physical integrity and safety of the glove as a barrier.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This description of nitrile examination gloves does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LZA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

The proposed devices with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K150340

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 ([e-mail]) or phone [phone] 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)

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.

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.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 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: [phone] Fax: [phone] Email: [e-mail]

• 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.

• 5. 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
• 6. 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.

• 7. 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.

• 8. 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 Examination
Gloves 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.	The POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice Blue) is a
disposable device intended for medical
purposes that is worn on the examiner's
hands to prevent contamination between
patient 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 Device
NITRILE 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 | |
| Physical
Properties | 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 in
accordance with ASTM D5151		Be free from holes when tested in
accordance with ASTM D5151	SAME
Powder Content		Less than 2 mg per glove when tested
in accordance with ASTM D6124		Meet the requirements of ASTM
6319	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
	NITRILE
EXAMINATION
GLOVES (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 a
sensitizer.	Under conditions of the study, not a
sensitizer.
	Acute
Systemic
Toxicity	Under conditions of the study, not
toxic	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.