Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a disposable examination glove, and the summary focuses on physical properties and biocompatibility testing, with no mention of AI/ML or related concepts.

Therapeutic

No.
The device (disposable nitrile examination gloves) prevents contamination between patient and examiner, which is a protective measure, not a treatment for a disease or condition.

Diagnostic

No
The device is described as examination gloves used to prevent contamination, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the 510(k) summary describes hardware-related testing and standards (ASTM, ISO) for physical properties and performance, not software functionality.

IVD (In Vitro Diagnostic)

No, 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." This is a barrier function, not a diagnostic function.
Device Description: The description focuses on the physical properties and standards related to gloves (ASTM D6124, ASTM D5151, ASTM D6319). These standards are for the performance and safety of gloves, not for diagnostic testing.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis.
Performance Studies: The performance studies focus on biocompatibility (skin irritation, sensitization, cytotoxicity, systemic toxicity) and physical properties (freedom from holes, dimensions, tensile strength). These are relevant to the safety and function of a glove as a barrier, not to its ability to perform a diagnostic test.
Key Metrics: The key metrics listed are related to the physical characteristics of the glove (residual powder, freedom from holes, dimensions, physical properties), not diagnostic performance metrics like sensitivity or specificity.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical barrier used during medical examinations.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable Nitrile Powder-Free 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 Disposable Nitrile Powder-Free 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 / 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 performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- Purpose: 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.
- Acceptance Criteria:
  - Skin Sensitization Test: provided grades less than 1, otherwise 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.
- Results:
  - All grades are 0. All animals were survived and no abnormal signs were observed during the study.
  - 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
- Purpose: This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.
- Acceptance Criteria: The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to

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 shows 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

June 22, 2022

Shandong Maida Medical Technology Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608.No.738.Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K221192

Trade/Device Name: Disposable Nitrile Powder-Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 18, 2022 Received: April 25, 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.

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.

Bifeng Qian, M.D., Ph.D. Acting 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) K221192

Device Name

Disposable Nitrile Powder-Free Examination Gloves

Indications for Use (Describe)

The Disposable Nitrile Powder-Free 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 K221192

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: Shandong Maida Medical Technology Co.,Ltd. Address: Room 102, Eastern building, No.166, South 1st Road, Development zone, Dongying, Shandong, China Phone Number: +86-13853370291 Contact: Kitty xu Date of Preparation: 2022.04.18

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 Powder-Free Examination 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 Regulation number: 21CFR880.6250 Classification: Class I General Hospital Panel:

4.0 Predicate device information

Ever Global (Vietnam) Enterprise Corp Manufacturer:

4

Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422

5.0 Indications For Use

The Disposable Nitrile Powder-Free 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

The proposed device is Powder Free Disposable Nitrile Powder-Free 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.

7.0 Summary comparing technological characteristics with predicate device

Item	Proposed device	Predicated device	Remark
510(k) number	Pending	K171422
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Indications for Use	The Disposable Nitrile
Powder-Free 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, Disposable
Nitrile Powder-Free
Examination Gloves,	Single-use indication,
powder free, device color,
device name, glove size
and quantity, Disposable
Powder Free Nitrile
Examination Glove,	Same

Table1-General Comparison

5

| Non

راز الاستق	VIVIIV

| Predicate

Device(K171422)	Designation	Size				Tolerance
	Length, mm	XS
230	S
230	M
230	L
230	XL
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
	Length, mm		S
220	M
230	L
230	XL
230	min
	Width, mm		80	95	110	120	$\pm 10$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.05					min
Remark	Analysis 1

Table2 Device Dimensions Comparison

Analysis1: The 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.

Item			Proposed device	Predicated device	Remark
Colorant			blue	White/ Blue/ Black/ Pink	Analysis2
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	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			0.15-0.19	Meet the requirements of
ASTM D6124	SIMILAR

Table3 Performance Comparison

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

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Item		Proposed device	Predicated device	Remark
Material		Nitrile	Nitrile	SAME
Biocompati
bility	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	Analysis3
	Systemic
toxicity	Under the conditions of the study,
the device does not elicit a systemic
toxicity response in the model
animal.	Complies with ISO
10993-11 Third edition
2017-09
Label and Labeling		Meet FDA's Requirement	Meet FDA'S
Requirement	SAME

Table4 Safety Comparison

Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.

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.

| 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