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 barrier function of a nitrile glove, with no mention of AI or ML technology.

Therapeutic

No
The device is a glove intended to prevent contamination, not to treat or alleviate a medical condition.

Diagnostic

No
The device is a non-sterile disposable glove intended to prevent contamination between patient and examiner, acting as a barrier. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of nitrile, not software. The description focuses on material properties and physical performance characteristics.

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 clearly states it's a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical properties of the nitrile glove as a barrier. It doesn't mention any components or functions related to analyzing biological samples.
Lack of IVD Indicators: There are no mentions of analyzing samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD device.

Therefore, the Xing Yu Powder Free Nitrile Patient Examination Gloves are a medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

LZA

Device Description

Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Examiner's hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Powder Free Nitrile Patient Examination Gloves, Blue Color made by Shandong Xingyu Gloves Co.,Ltd met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.

Dimension per ASTM D6319-10(Reapproved 2015)
Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-10(Reapproved 2015)
Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20
Powder Residual tests per ASTM D6319-10(Reapproved 2015)
Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.

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.

K120970

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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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's emblem, which consists of a stylized caduceus-like symbol with three intertwined figures, representing health and well-being. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 20, 2017

Shandong Xingyu Gloves Co., Ltd % Chu Xiaoan Official Correspondent Beijing Easylink Co,Ltd Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang Beijing, 100121 Cn

Re: K171616

Trade/Device Name: Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 18, 2017 Received: June 1, 2017

Dear Chu Xiaoan:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Tara A. Ryan -S

for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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)

K171616

Device Name

XingYu Powder Free Nitrile Patient Examination Gloves, Blue Color

Indications for Use (Describe)

Xing Yu Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger 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

"The assigned 510(k) number is:

Premarket Notification [510(k)] Summary

1.0 Submitter:

Submitter's name :	Shandong Xingyu Gloves Co.,Ltd
Submitter's address :	No.2158, Yaoqian Road,Economic
Development Zone,Gaomi
City,Shandong,261502,China
Phone number :	0086-536-2588123
Fax number :	0086-536-2586328
Name of contact person:	Xu Qiang
Date of preparation :	2017-07-18

2.0 Name of the Device

| Proprietary/Trade name: | Xingyu Powder Free Nitrile Patient
Examination Gloves, Blue Color |
|-------------------------|----------------------------------------------------------------------|
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |

3.0 Predicate device

| Device Name: | Powder Free Nitrile Patient Examination
Glove, Blue Color |
|----------------|--------------------------------------------------------------|
| Company name: | Tangshan Zhonghong Pulin Plastic Co., Ltd. |
| 510(K) Number: | K120970 |

4.0 Device Description:

4.1 How the device functions:

Nitrile films form a barrier to prevent contamination between patient and examiner.

4.2 Scientific concepts that form the basis for the device

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

4.3 Physical and performance characteristics such as design, materials and physical properties:

4

The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.

5.0 Device Indication for use:

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

6.0 Summary of the Technological Characteristics of the Device:

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color, non-sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard
Dimension	ASTM standard D 6319-10(Reapproved 2015)
	Length	$\geq$ 230mm
	Width	Small 70-90 mm
		Medium 85-105mm
		Large 100-120mm
X large 110-130 mm
Thickness	Fingertip $\geq$ 0.05mm
	Palm $\geq$ 0.05mm
Physical
Properties	ASTM standard D 6319-10(Reapproved 2015)
Tensile strength(Before aging) $\geq$ 14MPa
Tensile strength(After aging)
Elongated rate(Before aging) $\geq$ 500%
Elongated rate(After aging) $>$ 400%
Freedom from
pinholes	21 CFR 800.20
	ASTM standard D 6319-10(Reapproved 2015).
Test method in accordance with ASTM D5151-06(Reapproved 2015)	Passed Standard Acceptance Criteria
Powder Residual	ASTM standard D 6319-10(Reapproved 2015)
Test method in accordance with D6124-06(Reaffirmation 2011)	Meets 0.1mg/glove
Biocompatibility	Primary Skin Irritation in rabbits ISO 10993-10: Third Edition 2010-08-01	Passes
Under the conditions of the study, the subject device is not a primary skin irritant
	Dermal sensitization in the guinea pig ISO 10993-10: Third Edition 2010-08-01	Passes
Under the conditions of the study, the subject device is not a skin sensitizer

7.1 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Powder Free Nitrile Patient Examination Gloves, Blue Color made by Shandong

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Xingyu Gloves Co.,Ltd met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.

Dimension per ASTM D6319-10(Reapproved 2015),
. Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-10(Reapproved 2015),
. Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20,
. Powder Residual tests per ASTM D6319-10(Reapproved 2015)
. Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.

8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:

Clinical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.

| Features &
Description | Predicate Device | Subject Device | Result of
Comparison |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Company | Tangshan Zhonghong Pulin
Plastic Co., Ltd. | Shandong Xingyu Gloves
Co.,Ltd | -- |
| 510(K) Number | K120970 | K171616 | |
| Product name | Powder Free Nitrile Patient
Examination Glove, Blue
Color | Xingyu Powder Free
Nitrile Patient
Examination Gloves, Blue | similar |
| Product Code | LZA | LZA | same |
| Size | Small/ Medium/
Large/X large | Small/ Medium/
Large/X large | same |
| Indications for
Use | Powder Free Nitrile Patient
Examination Glove, Blue
Color 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. | Powder Free Nitrile
Patient Examination
Gloves, Blue Color 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. | similar |
| Device
Description and
Specifications | Meets ASTM D6319-10 | Meets ASTM
D6319-10(Reapproved
2015) | similar |
| Dimensions
--Length
ILS-2
AQL4.0 | Meets ASTM
D6319-10
≥230mm min | 232 mm min for all sizes | similar |
| Dimensions
-- Width
IL S-2
AQL4.0 | Meets ASTM D6319-10
Small 70-90 mm
Medium 85-105mm
Large 100-120mm
X large 110-130 mm | Small 76-88 mm
Medium 89-102 mm
Large 108-119mm
X large 115-128 mm | similar |

9.0 Substantial Equivalence Comparison:

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| Dimensions
--Thickness
IL S-2

AQL4.0	Meets ASTM D6319-10		Thickness (mm) min.		similar
	Finger 0.05mm min.
Palm 0.05mm min.		Finger 0.08
Palm 0.08
Physical
Properties
IL S-2
AQL4.0	Meets ASTM D D6319-10	Aging	Before	After	similar
	Before aging/after aging
Tensile Strength≥ 14MPa	Elongation
(%)	530-600	460-580
	Before aging
Elongation ≥500%
After aging
Elongation ≥400%	Tensile
Strength
(MPa)	18-25	17-22
Freedom from
Pinholes	Meets
• 21 CFR 800.20
• ASTM D6319-10	Meets
• 21 CFR 800.20
• ASTM D
6319-10(Reapproved

                                                   |                          |         | same    |

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Labeling for the	-Powder Free	-Powder Free
legally	-Patient Examination Glove	-Patient Examination Glove
marketed device	-Single Use Only	-Single Use Only
to which	- Manufactured For:	- Manufactured For:
substantial	- Lot	- Lot
equivalence is	-Blue color	-Blue color
claimed.	- Non sterile	- Non sterile

Conclusion: 10.0

Based on the nonclinical tests data, it can be concluded that the Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color is as safe, as effective, and performs as well as the predicate device, Powder Free Nitrile Patient Examination Glove, Blue Color by Tangshan Zhonghong Pulin Plastic Co., Ltd., K120970.