Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and physical characteristics of gloves, with no mention of AI/ML or data processing.

Therapeutic

No
The device, disposable nitrile gloves, prevents contamination and is not intended to treat, mitigate, or cure any disease or condition.

Diagnostic

No
Explanation: The device, disposable nitrile gloves, is intended to prevent contamination between patient and examiner. There is no indication that it is used to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device is described as disposable nitrile gloves, which are a physical product and not software. The description focuses on material properties and physical testing.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is clearly stated as "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
Device Description: The description focuses on the physical characteristics and standards related to the glove's material and integrity.
Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside of the living body) for diagnostic purposes.

The device is a medical device, specifically a Class I examination glove, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

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 / Not Found

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

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

Study type: Non-Clinical Performance Testing.
Sample size:
ISO 10993-10:2010 (Skin Sensitization Test): All animals were survived.
ASTM D5151-06 (Detection of Holes in Medical Gloves): Samples number: 125 gloves.

Key Results:
ISO 10993-10:2010 (Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization):

Skin Sensitization Test: All grades are 0. All animals were survived and no abnormal signs were observed during the study.
Skin Irritation Test: The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
ISO 10993-5:2009 (Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity): Viab.% of 100% test article extract is 71.75%. The proposed device has no potential toxicity to L-929 in the MTT method.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves: 0.06 mg/glove.
ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves: no glove water leakage found.
ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application:
Sterility: no need.
Freedom from holes: Please refer to No. 5 in table 5.
Dimensions:
- S: width: 82-86 mm, Length 238-245 mm
- M: width 97-99 mm, Length 243-249 mm
- L: width 108-111 mm, Length 244-254 mm
- XL: width 115-118 mm, Length 237-246 mm
- Thickness: Finger 0.13-0.15 mm, Palm 0.08 mm
Physical properties:
- Before aging: Tensile strength 14.12-22.10MPa, Ultimate Elongation 537.05% - 907.44%
- After Accelerated Aging: Tensile strength 14.46-20.20MPa, Ultimate Elongation 542.91% - 856.03%
- Powder-free Residue: Please refer to No. 4 in table 5.

Key Metrics

Not Found

Predicate Device(s)

K171422

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). On the left, there is a seal with a stylized depiction of human figures. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" in bold, followed by "ADMINISTRATION" in a smaller font size. The logo is simple and professional, conveying the organization's role in regulating food and drugs in the United States.

September 15, 2021

Jiangsu Shenglijie Safety Products Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K212009

Trade/Device Name: Disposable Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 21, 2021 Received: June 28, 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.

1

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 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 Clarence W. Murray, III, Ph.D. 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

2

Indications for Use

510(k) Number (if known) K212009

Device Name Disposable nitrile gloves

Indications for Use (Describe)

The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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 - K212009

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

1.0 Submitter's information

Name: JIANGSU SHENGLIJIE SAFETY PRODUCTS CO.,LTD Address: NO.88 SI ROAD RUDONGMAXI INDUSTRIAL ZONE MATANG TOWN, NANTONG JIANGSU, 226401, CHINA Phone Number: +86-13813628939 Contact: Andy Jiang Date of Preparation: 2021.06.21

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device information

Trade name: Disposable nitrile gloves

Common name: Patient Examination Gloves

Classification name: Non-powdered patient examination glove

S, M, L, XL Model(s): 3.0 Classification

Production code: LZA Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate device information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/

4

Blue/ Black/ Pink Color 510(k) number: K171422

5.0 Indications for use

The Disposable nitrile gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

6.0 Device description

The proposed device is Powder Free Disposable nitrile gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

7.0 Summary comparing technological characteristics with predicate device

Item	Proposed device	Predicated device	Remark
510(k) number	K212009	K171422
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Indications for use	The Disposable nitrile
gloves is a disposable
device intended for
medical purposes that is
worn on the examiner's
hands to prevent
contamination between
patient and examiner.	The Disposable Powder
Free Nitrile Examination
Glove, White/ Blue/ Black/
Pink Color is a disposable
device intended for
medical purposes that is
worn on the examiner's
hands to prevent
contamination between
patient and examiner.	Same
Powdered or Powered free	Powdered free	Powdered free	Same
Design Feature	ambidextrous	ambidextrous	Same
Labeling Information	Single-use indication,
powder free, device color,
device name, glove size
and quantity, Disposable
nitrile gloves, Non-Sterile	Single-use indication,
powder free, device color,
device name, glove size
and quantity, Disposable
Powder Free Nitrile
Examination Glove,
Non-Sterile	Same

Table1-General Comparison

5

Single use	Yes	Yes	Same
Sterility or not	Non-Sterile	Non-Sterile	Same

Predicate	Designation	Measured Size				Tolerance
Device(K171422)		XS	S	M	L	XL
	Length, mm	230	230	230	230	230	min
	Width, mm	75	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05				min
	Palm	0.05				min
Proposed Device	Designation	Measured Size				Tolerance
		S		M	L	XL
	Length, mm	238		241	244	237	min
	Width, mm	82-86		97-99	108-111	115-118	±2
	Thickness, mm:
	Finger	0.13				min
	Palm			0.08			min

Table2 Device Dimensions Comparison

Analysis1 : The measured sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Table3 Performance Comparison

Item	Proposed device	Predicated device	Remark
Colorant	blue	White/ Blue/ Black/ Pink	Analysis 2
Physical
Properties	Before Aging Tensile Strength	14MPa, min	14MPa, min	SAME
	Ultimate Elongation	500%min	500%min	SAME
	After Aging Tensile Strength	14MPa, min	14MPa, min	SAME
	Ultimate Elongation	400%min	400%min	SAME
Comply with ASTM D6319		Comply with ASTM D6319	SAME
Freedom from Holes	Be free from holes when tested in accordance with ASTMD5151 AQL=2.5	Be free from holes when tested in accordance with ASTMD5151 AQL=2.5	SAME

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| Powder Content | 0.06 mg/glove | Meet the requirements of SIMILAR
ASTM D6124 |

----------------	---------------	------------------------------------------------

Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect the safety of proposed device

Table4 Safety Comparison

Item	Proposed device	Predicated device	Remark
Material	Nitrile	Nitrile	SAME
Biocompatibility	Irritation
Under the conditions of the study, not an irritant	Comply with ISO10993-10	SAME
	Sensitization
Under conditions of the study, not a sensitizer.
	Cytotoxicity
Under the conditions of the study, the device is potentially cytotoxic	Comply with ISO10993-5	SIMILAR
Label and Labeling	Meet FDA's Requirement	Meet FDA's Requirement	SAME

8.0 Summary of Non-Clinical Performance Testing

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

Table 5 Summary of Non-Clinical Performance Testing

| No. | Name of the Test
Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010
Biological Evaluation Of
Medical Devices - Part
10: Tests For Irritation
And Skin Sensitization. | This part of ISO 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test:
provided grades less than 1, otherwise sensitization. | All grades are 0.