K Number

Device Name

Nitrile Patient Examination Gloves

Manufacturer

Yingxiang Glove Products Co., Ltd.

Date Cleared

2021-10-14

(115 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

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

Device Description

The proposed device is Powder Free Nitrile Patient Examination 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K171422

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard medical glove and the summary contains no mention of AI or ML.

Therapeutic

No
The device prevents contamination, it does not treat a condition or disease.

Diagnostic

The device description clearly states it is for preventing contamination between patient and examiner, not for diagnosing any medical condition.

SaMD (Software as a Medical Device)

The device description and performance studies clearly indicate the device is a physical product (gloves) and there is no mention of any software component.

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 clearly stated as "worn on the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for diagnostic purposes.
Device Description: The description focuses on the physical properties and standards related to gloves (material, powder-free, color, standards like ASTM D6124, D5151, D6319). These are typical characteristics of medical gloves, not IVD devices.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, assays, or any other components typically associated with in vitro diagnostics.
Performance Studies: The performance studies described focus on the physical integrity, biocompatibility (skin sensitization, irritation, cytotoxicity), and freedom from holes, which are relevant to the safety and effectiveness of a glove as a barrier. They do not involve diagnostic performance metrics like sensitivity, specificity, or accuracy in detecting a condition.

In summary, the device is a medical glove intended for barrier protection, not for performing diagnostic tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nitrile Patient Examination 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 Nitrile Patient Examination 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 / medical purposes

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)

Non-clinical tests were conducted to verify that the proposed device met all design specifications and acceptance criteria. The test results demonstrated that the proposed device complies with the following standards:
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
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19,Standard Specification For Nitrile Patient Examination Gloves For Medical Application.
ASTM D7160-16,Standard Practice for Determination of Expiration Dating for Medical Gloves

For 9-inch gloves:
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.
Cytotoxicity Test: Viab.% of 100% test article extract is 71.6%. It means the proposed device have no potential toxicity to L-929 in the MTT method.
Residual Powder Test: 0.08 mg /glove.
Freedom from Holes Test: no glove water leakage found (Sample number: 125 gloves, AQL: 2.5 (ISO 2859), Criterion

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 14, 2021

Yingxiang Glove 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: K211914

Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 7, 2021 Received: September 13, 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.

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

Indications for Use

510(k) Number (if known) K211914

Device Name Nitrile Patient Examination Gloves

Indications for Use (Describe)

The Nitrile Patient Examination 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 K211914

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

1.0 submitter's information

Name: Yingxiang Glove Products Co., Ltd. Address: No. 1, Zhendong Industrial Park, Huagiao Town, Wuxue City, Huanggang City, Hubei Province, 435400, China Phone Number: +86-15982348869 Contact: Liu Penq Date of Preparation: 2021.06.06

Designated Submission Correspondent

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

2.0 Device information

Trade name: Nitrile Patient Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): 9-inch (S, M, L, XL), 12-inch (S, M, L, XL)

3.0 Classification

Production code: LZA Regulation 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/ Blue/ Black/ Pink Color

510(k) number: K171422

5.0 Indications for Use

The Nitrile Patient Examination 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

7.0 Technological Characteristics Comparison

Item	Proposed device	Predicated device	Comparison
510(k) number	K211914	K171422
Product Code	LZA	LZA	Same
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
Indications for Use	The Nitrile Patient
Examination 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, Nitrile Patient
Examination 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

Table2 Device Dimensions Comparison

Predicate	Designation	Size					Tolerance
Device(K171422)		XS	S	M	L	XL

	Length, mm	230	230	230	230	230	min
	Width, mm	75	85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
Proposed Device	Designation	Size					Tolerance
		S	M	L	XL
	9-inch	Length, mm	220	230	230	230	min
		Width, mm	80	95	110	120	$\pm 10$
	12-inch	Length, mm	220	230	230	230	min
		Width, mm	80	95	110	120	$\pm 10$
	Thickness, mm:
	9-inch	Finger	0.05
	12-inch	Palm	0.05
Remark	Analysis 1

Table3 Performance Comparison

Item				Proposed device	Predicated device	Comparison
Colorant				blue	White/ Blue/ Black/ Pink	Analysis2
9-inch	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
	Powder Content			0.08	Meet the requirements of ASTM D6124	SIMILAR
12-inch	Physical Properties	Before Aging	Tensile Strength	14MPa, min	14MPa, min	SAME
			Ultimate	500%min	500%min	SAME

		Elongation
	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
Powder Content		0.11		Meet the requirements of
ASTM D6124	SIMILAR

Analysis1: The proposed device has different sizes and tolerances to the predicate device.

Analysis2: The proposed device has different color to the predicate device.

Table4 Safety Comparison

Item		Proposed device	Predicated device	Comparison
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 conditions of the study, did not show potential toxicity to L-929 cells.	Comply with ISO10993-5	SIMILAR
Label and Labeling		Meet FDA's Requirement	Meet FDA's Requirement	SAME

8.0 Summary of Non-clinical Testing

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

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19,Standard Specification For Nitrile Patient Examination Gloves For Medical Application.

ASTM D7160-16,Standard Practice for Determination of Expiration Dating for Medical Gloves

9-inch
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.
All animals were survived and no abnormal signs
were observed during the study.
2			Skin Irritation Test:
If the primary irritation index
is 0-0,4, the response
category is Negligible.
0,5-1,9 means slight
2-4,9 means moderate
5-8 means severe	The primary irritation index is 0.
The response of the proposed device was
categorized as negligible under the test condition
3	ISO 10993-5:2009
Biological
Evaluation Of
Medical Devices -
Part 5: Tests For In
Vitro Cytotoxicity	This part of ISO
10993 describes test
methods to assess
the in vitro cytotoxicity
of medical devices.	The viab.% of the 100%
extract of the test article is
the final result, and if
viability is reduced to
500%
After Accelerated Aging
Tensile strength ≥14MPa
Ultimate Elongation >
400%
Powder-free Residue:
pl. Refer to No. 4 in table 5	N.A.
Dimensions:
S: width: 81-87 mm
Length 228-234 mm
M: width 94-96 mm
Length 242-254 mm
L: width 100-109 mm
Length 268-274 mm
XL: width 112-119 mm
Length 245-252 mm
Thickness:
Finger 0.11-0.13 mm
Palm 0.07-0.08 mm
Physical properties:
Before aging
Tensile strength 16.72-26.66 MPa
Ultimate Elongation 518.19% - 849.65%
After Accelerated Aging
Tensile strength 15.34-21.73 MPa
Ultimate Elongation 560.54% - 799.91%
Powder-free Residue:
pl. Refer to No. 5 in table 5
12-Inch
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.
All animals were survived and no abnormal signs
were observed during the study.

2			Skin Irritation Test:
If the primary irritation index
is 0-0,4, the response
category is Negligible.
0,5-1,9 means slight
2-4,9 means moderate
5-8 means severe	The primary irritation index is 0.
The response of the
proposed device was
categorized as negligible under the test condition
3	ISO 10993-5:2009
Biological
Evaluation Of
Medical Devices -
Part 5: Tests For In
Vitro Cytotoxicity	This part of ISO
10993 describes test
methods to assess
the in vitro cytotoxicity
of medical devices.	The viab.% of the 100%
extract of the test article is
the final result, and if
viability is reduced to