Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device, Nitrile Examination Gloves, is described as a barrier to prevent contamination, not as a device that delivers therapy or treatment. Its function is protective rather than therapeutic.

Diagnostic

No
The device is described as "Nitrile Examination Gloves," which are used to prevent contamination between patient and examiner. There is no mention of the device being used to diagnose conditions or process diagnostic information.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) made of nitrile butadiene rubber, not software. The description focuses on material properties, dimensions, and physical performance tests.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "to prevent contamination between patient and examiner" by being worn on the examiner's hand. This is a barrier function, not a diagnostic function.
Device Description: The description focuses on the physical properties and material of the gloves, not on any components or processes used to analyze biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, test strips, or analytical instruments described.
Performance Studies: The performance studies focus on the physical properties and biocompatibility of the gloves, which are relevant to their barrier function and safety, not to diagnostic accuracy.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner's hand / Over-The-Counter Use

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

Bench 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:

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
A table is provided with specific test methods, purposes, acceptance criteria, and test results for dimensions (palm width, length, finger thickness, palm thickness), physical properties (tensile strength, ultimate elongation before and after aging), freedom from holes (Pass at AQL 2.5), powder residue (≤2mg/glove), biocompatibility (skin irritation, skin sensitization, acute systemic toxicity). All tests met the specified acceptance criteria.

Key Metrics

Dimensions: Overall Length (S: Min 220mm, M: Min 230mm, L: Min 230mm, XL: Min 230mm), Palm Width (S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm), Finger Thickness (Min 0.05mm), Palm Thickness (Min 0.05mm).
Physical Properties (Before Aging): Tensile Strength: min 14Mpa, Ultimate Elongation: min 500%.
Physical Properties (After Aging): Tensile Strength: min 14Mpa, Ultimate Elongation: min 400%.
Freedom from Holes: Pass at AQL 2.5.
Powder residue: Below 2mg/glove of residual powder.
Biocompatibility: Skin Irritation (not an irritant), Skin Sensitization (not a sensitizer), Acute Systemic Toxicity (not a systemic toxicity).

Predicate Device(s)

K211319

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

February 18, 2022

Wuhan Zonsen Medical Products Co.,Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K213688

Trade/Device Name: Nitrile Examination Gloves (Model: ZMG1351) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 10, 2021 Received: November 23, 2021

Dear Doris Dong:

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.

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) K213688

Device Name

Nitrile Examination Gloves (Model: ZMG1351)

Indications for Use (Describe)

Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

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

[As required by 21 CFR 807.92]

1. Submission Information

510(k) Number:	K213688
Date:	February 3rd, 2022
Type of 510(k) Submission:	Traditional 510(k)
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Wuhan Zonsen Medical Products Co.,Ltd
No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City,
Hubei Province, China
Tel: +86-27-82737771
E-mail: Cynthia@zonsenmed.com
Contactor:	Doris Dong
Shanghai CV Technology Co., Ltd.
Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China
E-mail: doris.d@ceve.org.cn
Tel: 86 21-31261348 / Fax: 86 21-57712250

2. Device Description

Proprietary Name:	Nitrile Examination Gloves
Model:	ZMG1351
Size:	S, M, L, XL
Classification Name:	Non-powdered patient examination glove
Product Code:	LZA
Device Class:	1
Regulation Number:	21 CFR 880.6250
Review Panel:	General Hospital
Indications for use:	Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description:	Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only.

3. Predicate Device Identification

510(k) Number:	K211319
Product Name:	Purism Non-Sterile Powder Free Nitrile Examination Gloves
Submitter/Manufacturer:	Dezhou Purism Medical Technology Co., Ltd.

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4. Technological Characteristics Comparison

Parameters	New Device	Predicate Device	Comparison
510(k) Number	K213688	K211319	---
510(k) Owner	Wuhan Zonsen Medical Products
Co.,Ltd	Dezhou Purism Medical
Technology Co., Ltd.	---
Device Name	Nitrile Examination Gloves	Purism Non-Sterile Powder Free
Nitrile Examination Gloves	---
Model	ZMG1351	/	---
Product Code	LZA	LZA	Same
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	Same
Class	1	1	Same
Intended use	Nitrile Examination Gloves are
disposable devices intended for
medical purposes that are worn
on the examiner's hand to prevent
contamination between patient
and examiner.	The Purism Non-Sterile Powder
Free Nitrile Examination Gloves
is disposable devices intended for
medical purposes that is worn on
the examiner's hand to prevent
contamination between patient
and examiner.	Same
Material	Nitrile Butadiene Rubber Latex	Nitrile Butadiene Rubber Latex	Same
Environment of
use	OTC	OTC	Same
Design	Disposable (Single use)	Disposable (Single use)	Same
	Non-sterile	Non-sterile	Same
	Powder-free	Powder-free	Same
	Ambidextrous	Ambidextrous	Same
	Cuffed	Cuffed	Same
Size	S, M, L, XL	S, M, L, XL	Same
Color	Blue	Blue	Same
Specifications	Powder-free Nitrile Examination
Gloves Meet ASTM D6319-19	Powder-free Nitrile Examination
Gloves Meet ASTM D6319-19	Same
Dimensions

Overall Length | Meets ASTM D6319-19
S: Min 220mm
M: Min 230mm
L: Min 230mm
XL: Min 230mm | Meets ASTM D6319-19
S: Min 230mm
M: Min 230mm
L: Min 230mm
XL: Min 230mm | Similar |
| Dimensions
Palm Width | Meets ASTM D6319-19
S: 80±10mm
M: 95±10mm
L: 110±10mm
XL: 120±10mm | Meets ASTM D6319-19
S: 80±10mm
M: 95±10mm
L: 110±10mm
XL: ≥110mm | |
| Dimensions
Finger Thickness | Meets ASTM D6319-19
Min 0.05mm | Meets ASTM D6319-19
Min 0.10±0.02mm | |
| Dimensions
Palm Thickness | Meets ASTM D6319-19
Min 0.05mm | Meets ASTM D6319-19
Min 0.06±0.02mm | |

5

| Physical Properties | Meets ASTM D6319-19
Before Aging:

Tensile Strength: min 14Mpa
Ultimate Elongation: min 500%
Meets ASTM D6319-19
After aging:
Tensile Strength: min 14Mpa
Ultimate Elongation: min 400% | Meets ASTM D6319-19
Before Aging:
Tensile Strength: min 14Mpa
Ultimate Elongation: min 500%
Meets ASTM D6319-19
After aging:
Tensile Strength: min 14Mpa
Ultimate Elongation: min 400% | Same |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Freedom from
Holes | Meets ASTM D6319-19
Pass at AQL 2.5 | ASTM D5151-06
Pass at AQL 2.5 | Similar |
| Powder residue | Meets ASTM D6319-19
Below 2mg/glove of residual
powder | Meets ASTM D6124-06
Below 2mg/glove of residual
powder | |
| Biocompatibility | Meets ISO 10993-10:2010;
Skin Irritation: Under the
condition of the test, not an
irritant.
Skin Sensitization: Under the
condition of the test, not a
sensitizer.
Meets ISO 10993-11:2017;
Acute Systemic Toxicity: Under
the condition of the test, not a
systemic toxicity. | Meets ISO 10993-10:2010;
Skin Irritation: Under the
condition of the test, not an
irritant.
Skin Sensitization: Under the
condition of the test, not a
sensitizer.
Meets ISO 10993-11:2017;
Acute Systemic Toxicity: Under
the condition of the test, not a
systemic toxicity.
Meets ISO 10993-5:2009;
In Vitro Cytotoxicity: Under the
condition of the test, cytotoxic | Similar |

5. Non-clinical Testing Summary

Bench 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:

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

Test Method	Purpose	Acceptance Criteria		Test Results
Dimension-
ASTM D6319-19	Evaluate the
glove palm width	Size	(mm)	(mm)
		S	$80\pm10$	84~86
		M	$95\pm10$	96~98
		L	$110\pm10$	104~106
		XL	$120\pm10$	113~115
	Evaluate the	Size	(mm)	(mm)
	glove length	S	Min 220	241~251
		M	Min 230	236~249
		L	Min 230	237~245
		XL	Min 230	240~249
	Evaluate the
glove finger
thickness	Size	(mm)	(mm)
		S	Min 0.05	0.111~0.137
		M	Min 0.05	0.124~0.150
		L	Min 0.05	0.112~0.133
	XL	Min 0.05	0.117~0.137
	Evaluate the
glove palm
thickness	Size	(mm)	(mm)
		S	Min 0.05	0.080~0.097
		M	Min 0.05	0.087~0.098
		L	Min 0.05	0.074~0.086
	XL	Min 0.05	0.077~0.094
Physical Properties-
ASTM D6319-19	Evaluate the
glove physical
propertiesbefore
and after aging	Before
Aging	After aging	Before Aging	After aging at
		Tensile
strength:	Tensile
strength:	Tensile
strength:	Tensile
strength:
		min 14Mpa	min 14Mpa	19.9~27.4Mpa	20.1~35.1Mpa
		Ultimate
elongation:	Ultimate
elongation:	Ultimate
elongation:	Ultimate
elongation:
		min 500%	min 400%	509~553%	454~504%
		Freedom from
Holes-
ASTM D6319-19	Detect the holes
that allow water
leakage	Do not show droplet, stream or other type of
water leakage
			Powder residue-
ASTM D6319-19	Evaluate the
residue powder	≤2mg/glove
				Skin Irritation -
ISO 10993-10:2010	Evaluated for the
potential to cause
skin irritation
Sensitization -
ISO 10993-10:2010	Evaluated for the
potential to cause
skin sensitization	Under the condition of the
test, not a sensitizer.			No- sensitization
	Acute Systemic
Toxicity-
ISO 10993-11:2017	Evaluated for
acute systemic
toxicity	Under the condition of the
test, not a systemic
toxicity.		No- acute systemic toxicity

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6. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, the Nitrile Examination Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K211319.