Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary contains no mention of AI, ML, or related technologies.

Therapeutic

No.
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition for therapeutic purposes.

Diagnostic

No

The device is a non-sterile disposable glove, intended to prevent contamination. It does not provide any diagnostic information or measurements about a patient's health condition.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate a physical, hardware-based device (nitrile examination gloves) and do not mention any software components.

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 device is "worn on the examiner's hands or finger to prevent contamination between patient and examiner." This is a barrier function for personal protection and infection control, not for the examination of specimens derived from the human body.
Device Description: The description confirms it's a "powder free nitrile examination glove." This aligns with a physical barrier device.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.

The device described is a Class I medical device (examination glove) intended for infection control, not for in vitro diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or finger

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

Non-clinical performance testing was conducted.
Tests included:

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. Results: 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. Results: Viab.% of 100% test article extract is 74.2%. It means the proposed device have potential toxicity to L-929 in the MTT method.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves. Results: 0.24 mg /glove.
ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves. Sample size: 125 gloves. Results: 0 glove water leakage found.
ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. This covers sterility (no need), freedom from holes (refer to ASTM D5151-06), dimensions, and physical properties.
- Dimensions:
  - S: width: 84-86 mm, Length 295-304 mm
  - M: width 94-97 mm, Length 296-302mm
  - L: width 104-107 mm, Length 297-302 mm
  - XL: width 113-117 mm, Length 296-303 mm
- Thickness:
  - S: Finger 0.136-0.155 mm, Palm 0.109-0.125 mm
  - M: Finger 0.136-0.155 mm, Palm 0.109-0.125 mm
  - L: Finger 0.150-0.171 mm, Palm 0.112-0.125 mm
  - XL: Finger 0.154-0.168 mm, Palm 0.113-0.129 mm
- Physical properties (Before aging): Tensile strength 17.9-40.5MPa; Ultimate Elongation 508.945% - 574.078%.
- Physical properties (After Accelerated Aging): Tensile strength 14.2-27.1 MPa; Ultimate Elongation 402.900% - 538.033%.

Key Metrics

Freedom from Holes: 0 glove water leakage out of 125 tested.
Powder Content: 0.24 mg/glove.

Predicate Device(s)

K211914

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

0

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2022

PingAn Medical Products Co.,Ltd. % Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K222527

Trade/Device Name: Nitrile Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 14, 2022 Received: November 14, 2022

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

1

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,

Bifeng Qian -S

Bifeng Qian, M.D., 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222527

Device Name Nitrile Patient Examination Glove

Indications for Use (Describe)

The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands 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 (K222527)

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

1.0 Submitter's Information

PingAn Medical Products Co.,Ltd. Name: Address: Zheji road, High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province, China Phone Number: +86-15247135174 Contact: Zhou Ziyu Date of Preparation: 2022.07.20

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Nitrile Patient Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): 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: Yingxiang Glove Products Co., Ltd. Device: Nitrile Patient Examination Gloves 510(k) number: K211914

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5.0 Indication for Use

The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

Table1-General Comparison
Item	Subject Device
(K222527)	Predicated Device
(K211914)	Remark
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use /
Indication for Use	The Nitrile Patient
Examination Glove is a
non-sterile disposable
device intended for
medical purposes that is
worn on the examiner's
hands or finger to prevent
contamination between
patient and examiner.	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.	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 Glove
Powder Free Blue,
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

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	Size
Predicate
Device
(K211914)	Designation		S	M	L	XL	Tolerance
	9-inch	Length, mm	220	230	230	230	min
		Width, mm	80	95	110	120	±10
	12-inch	Length, mm	220	230	230	230	min
		Width, mm	80	95	110	120	±10
	Thickness, mm:
	9-inch/
12-inch	Finger
Palm	0.05				min
			0.05				min
Subject
Device	12 inch	Designation	S	M	L	XL	Tolerance
		Length, mm	220	230	230	230	min
		Width, mm	80	95	110	120	±10
		Thickness, mm:
		Finger	0.05				min
		Palm	0.05				min
		SIMILAR

Analysis: The physical dimensions of subject device are same with the 12 inch ones of the predicate device, and they all meet the requirements of ASTM D6319-19.

Item	Subject device (Pending)	Predicated device (K211914)	Remark
Colorant	Blue	Blue	Same
Physical Properties	Before Aging
Tensile Strength	14MPa, min	14MPa, min	Same
	Before Aging
Ultimate Elongation	500% min	500% min	Same
	After Aging
Tensile Strength	14MPa, min	14MPa, min	Same
	After Aging
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

Table3 Performance Comparison

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| Powder Content | 0.24 mg/glove | Meet the requirements of Similar
ASTM D6124 |

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

Table4 Safety Comparison

Item		Subject device (Pending)	Predicated device (K211914)	Remark
Material		Nitrile	Nitrile	Same
Biocompatibility	Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)	Under the conditions of the study, not an irritant
	Sensitization (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)	Under conditions of the study, not a sensitizer.	Comply with ISO10993-10	Same
	Cytotoxicity (ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)	Under conditions of the study, device extract is not 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.

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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 | 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 | | medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | 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