Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.

Therapeutic

No
The device, a Vinyl Examination Glove, is intended to prevent contamination between patient and examiner, primarily functioning as a barrier rather than actively treating a condition or disease.

Diagnostic

No

The device is a Vinyl Examination Glove, intended to prevent contamination. It does not collect or analyze data about a patient's health to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (gloves) and the performance studies focus on physical and biological properties, not software performance.

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 the device is "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the human body.
Device Description: The description details a physical barrier (glove) with specifications related to size, material, and sterility. It does not describe any components or processes related to analyzing biological samples.
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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls

The device is a medical device, specifically a Class I medical device (based on the predicate device K number), but its function is protective and preventative, not diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Product codes

LYZ

Device Description

The subject device is powder free vinyl examination gloves. The subject device is clear. It can be available in four specifications: S,M,L and XL. 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

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 (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. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Physical Dimensions Test (ASTM D6319):
Length(mm): > 230/Pass;
Width(mm): S: 80-89 /Pass; M: 90-98/ Pass; L: 100-107/ Pass; XL:111-118/ Pass
Thickness (mm): Finger: 0.08-0.17/Pass; Palm: 0.08/Pass

Watertightness Test for Detection of Holes (ASTM D5151): 0/125/Pass

Powder Content (ASTM D6124): 0.16-0.20mg/Pass

Physical properties (ASTM D412):
Before Aging:
Tensile Strength: 11-27MPa/Pass;
Ultimate Elongation: 304-607%/Pass;
After Aging:
Tensile Strength: 11-24MPa/Pass;
Ultimate Elongation: 300-499%/Pass;

Biocompatibility:
Cytotoxicity (ISO 10993-5): In Vitro Cytotoxicity
Acute Systemic Toxicity (ISO 10993-11): Non- acute systemic toxicity
Irritation (ISO 10993-10): Non-irritating
Sensitization (ISO 10993-10): Under conditions of the study, not a sensitizer / Pass

Predicate Device(s):

K180861

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 shows 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.

December 21, 2021

Taian Hengchang Medical Technology Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801. No. 161 Luiiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K213006

Trade/Device Name: Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: September 6, 2021 Received: September 20, 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

1

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 (OS) 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,

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

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Indications for Use

510(k) Number (if known) K213006

Device Name Vinyl Examination Gloves

Indications for Use (Describe)

The Vinyl Examination Glove is a disposable device intended for medical purposes that is 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 K213006

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

1.0 Submitter's Information

Name: Taian Hengchang Medical Technology Co.,Ltd. Address: No. 88 Central Road, Sunbo Town Industrial Park in Feicheng, Taian City, Shandong Province, China. Phone Number: +86 15963319855 Contact: Jing Li Date of Preparation: Sept 6, 2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Vinyl Examination Gloves Common name: Vinyl Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

3.0 Classification

Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: ZHICHENG TRADING CO., LTD. Device: Vinyl Examination Glove (Clear, Non-Colored) 510(k) number: K180861

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5.0 Indication for Use

The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

6.0 Device Description

The subject device is powder free vinyl examination gloves. The subject device is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

Item	Subject Device	Predicated Device	Remark
510(k) number	K213006	K180861	/
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The Vinyl Examination
Glove is a disposable
device intended for
medical purposes that is
worn on the examiner's
hands to prevent
contamination between
patient and examiner.	The Vinyl Examination
Glove (Clear,
Non-Colored) is a
disposable device
intended for medical
purposes that is worn on
the examiner's hands to
prevent contamination
between patient and
examiner.	Same
Material	Vinyl	Vinyl	Same
Powdered or
Powered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Colorant	Clear	Clear	Same
Labeling
Information	Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile	Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile	Same
Dimensions(mm)	Length:
S/M/L/XL: ≥230;
Width:
S: 85+5;	Length:
S≥230;
M≥235;
L≥245;	Similar

Table1-General Comparison

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| | M: 95±5;
L: 105±5;
XL: 115±5 | XL≥245;
Width:
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | | | | |
|------------------------|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------|------------|-----------|
| | | | | | | |
| | Thickness(mm) | Finger: ≥0.08;
Palm: ≥0.08 | Finger: ≥0.05;
Palm: ≥0.08 | Similar | | |
| Physical
Properties | Before
Aging | Tensile Strength | 11MPa, min | Tensile Strength | 15MPa, min | Different |
| | | Ultimate Elongation | 300% min | Ultimate Elongation | 380% min | Different |
| | After
Aging | Tensile Strength | 11MPa, min | Tensile Strength | 15MPa, min | Different |
| | | Ultimate Elongation | 300%min | Ultimate Elongation | 380%min | Different |
| | 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=1.5 | Different | | |
| | Powder Content | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same | | |
| | Biocompatibility | ISO 10993-10;
Under the conditions of the study, not an irritant or a sensitizer | Comply with ISO10993-10 | Same | | |
| | | ISO 10993-5
Under conditions of the study, device extract is cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5 | / | | |
| | | ISO 10993-11;
Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo | / | | | |
| | | | | | | |

Analysis: The physical dimensions are different with that of the predicate.

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Analysis: The tensile strength and ultimate elongation are different with that of the predicate.

8.0 Summary of Non-clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

| Test

Method	Purpose	Acceptance Criteria	Results
ASTM
D6319	Physical
Dimensions
Test	Length(mm):
S/M/L/XL: $\ge$ 230;
Width(mm):
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5
Thickness (mm):
Finger: $\ge$ 0.08
Palm: $\ge$ 0.08	Length(mm):

230/Pass;
Width(mm):
S: 80-89 /Pass
M: 90-98/ Pass
L: 100-107/ Pass
XL:111-118/ Pass
Thickness (mm):
Finger: 0.08-0.17/Pass
Palm: 0.08/Pass |
| ASTM
D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of ASTM D5151
AQL 2.5 | 0/125/Pass |

Table 2 - Summary of non-clinical performance testing

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| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM D6124