Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device, a vinyl examination glove, is intended to prevent contamination between the patient and examiner, not to treat or cure a disease or medical condition.

Diagnostic

No
The device is described as an examination glove intended to prevent contamination, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical product (vinyl examination gloves) and the summary describes physical characteristics and performance testing related to the material and construction of the gloves, not software.

IVD (In Vitro Diagnostic)

No, 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 is a barrier function, not a diagnostic test performed on a sample from the body.
Device Description: The description details a physical glove, not a reagent, instrument, or kit used to analyze biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, test strips, or analytical procedures described.
Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove (strength, watertightness, irritation, etc.), which are relevant to its barrier function, not diagnostic accuracy.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

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's color 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 systematic 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.

Summary of non-clinical performance testing:

ASTM D5250 (Physical Dimensions Test):
- Acceptance Criteria: Length(mm): S/M/L/XL: ≥230; Width(mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5; Thickness (mm): Finger: ≥0.08, Palm: ≥0.08
- Results: Length(mm): > 230/Pass; Width(mm): S: 81-88 /Pass, M: 90-98/ Pass, L: 100-109/ Pass, XL:110-118/ Pass; Thickness (mm): Finger: 0.08-0.14/Pass, Palm: 0.08/Pass
ASTM D5151 (Watertightness Test for Detection of Holes):
- Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5
- Results: 0/125/Pass
ASTM D6124 (Powder Content):
- Acceptance Criteria: Meet the requirements of ASTM D6124

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 and 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 ADMINISTRATION" in blue text.

February 17, 2022

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

Re: K213625

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: November 11, 2021 Received: November 17, 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.

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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 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, 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) K213625

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 K213625

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

1.0 Submitter's Information

Name: Dezhou Hengchang Medical Technology Co., Ltd. Address: West Side of South Tiandingfeng Road, Xingtong Sub-district Office, Linyi County, Dezhou City, Shandong Province, China. Phone Number: +86 15963319855 Contact: Jing Li Date of Preparation: Nov.11, 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: 21 CFR 880.6250 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's color 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
(K213625) | Predicated Device
(K180861) | Comparison |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 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
Analysis 1 |

Table1-General Comparison

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	M: 95±5;	XL≥245;
	L: 105±5;	Width:
	XL: 115±5	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
Analysis 1
Physical
Properti
es	Befor
e
Aging	Tensile
Strength	11MPa,
min	Tensile
Strength	15MPa,
min	Similar
Analysis 2
		Ultimate
Elongation	300% min	Ultimate
Elongation	380% min	Similar
Analysis 2
	After
Aging	Tensile
Strength	11MPa,
min	Tensile
Strength	15MPa,
min	Similar
Analysis 2
		Ultimate
Elongation	300%min	Ultimate
Elongation	380%min	Similar
Analysis 2
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		Similar
Analysis 3
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 1: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250.

Analysis 2: The tensile strength and ultimate elongation are different with that

6

of the predicate, but they all meet the requirements of ASTM D5250.

Analysis 3: Freedom from holes of subject device is similar with that of the predicate, but they all meet the requirements of ASTMD5151.

8.0 Summarv 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
D5250	Physical
Dimensions
Test	Length(mm):
S/M/L/XL: ≥230;
Width(mm):
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5
Thickness (mm):
Finger: ≥0.08
Palm: ≥0.08	Length(mm):

230/Pass;
Width(mm):
S: 81-88 /Pass
M: 90-98/ Pass
L: 100-109/ Pass
XL:110-118/ Pass
Thickness (mm):
Finger: 0.08-0.14/Pass
Palm: 0.08/Pass |
| ASTM | Watertightness | Meet the requirements of ASTM D5151 | 0/125/Pass |

Table 2 - Summary of non-clinical performance testing

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| D5151 | Test
for
Detection
of
Holes | AQL 2.5 | | | | |
|-----------------|-----------------------------------------|---------------------------------------------|------------------------|--------|----------------|---------------------------------------------------------------------------------------------|
| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM D6124