Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

• K Number: K182043
• Device Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
• Manufacturer: Hebei Titans Hongsen Medical Technology Co., LTD.
• Date Cleared: 2018-09-21 ( 53 days)
• Product Code: LYZ
• Regulation Number: 880.6250

Intended Use

The Single-use medical poly (vinyl chloride) 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.

Device Description

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

Predicate Devices

K163168, K180849

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary makes no mention of AI or ML capabilities.

Therapeutic

No
The device is a medical glove intended for preventing contamination, not for treating a disease or condition.

Diagnostic

No

The device is described as a "disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner." This indicates its function as a barrier, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, not a software application. The description focuses on material properties and physical standards.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Device's Intended Use: The intended use of this device is clearly stated as "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
• Lack of Specimen Examination: The description does not mention any interaction with or analysis of human specimens.
• Focus on Physical Properties: The performance studies and key metrics listed (Tensile Strength, Ultimate Elongation, Freedom from Holes, Powder Content) relate to the physical integrity and safety of the glove as a barrier, not to diagnostic information derived from biological samples.

Therefore, based on the provided information, this device is a medical glove intended for barrier protection, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Single-use medical poly (vinyl chloride) 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.

Product codes

LYZ

Device Description

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. 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's, medical purposes

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 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 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
• ISO 10993-5:2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro A Cytotoxicity
• ASTM D6124-06 (Reaffirmation 2017), Standard Test Method for Residual Powder on Medical Gloves
• ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
• ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

Key Metrics

Not Found

Predicate Device(s)

K163168, K180849

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 contains the logo of the U.S. Food & 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.

September 21, 2018

Hebei Titans Hongsen Medical Technology Co., LTD. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5 YiHe North Rd., FangShan District Beijing, 102401 Cn

Re: K182043

Trade/Device Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 23, 2018 Received: July 30, 2018

Dear Ray 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Tina Kiang, Ph.D. 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)

K182043

Device Name

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

Indications for Use (Describe)

The Single-use medical poly (vinyl chloride) 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.

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

This 510(k) Summary is being submitted in accordance with Title 21, CFR Section 807.92.

The assigned 510(k) Number: K182043

• 1. Date of Preparation:2018/08/18
• 2. Sponsor Identification

HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD. EASTERN INDUSTRIAL ZONE, NANGONG CITY, HEBEI PROVINCE, CHINA

Contact Person: Mr. ShaoZhang Nan Tel: [phone] Fax: [phone] Email: [e-mail]

• 3. Designated Submission Correspondent
     Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Tel: [phone], Fax: [phone] Email: Ray.Wang(@believe-med.com

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4. Identification of Proposed Device

Trade Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): XS S M L XL

Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification:1 Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use Statement:

The Single-use medical poly (vinyl chloride) 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.

• 5. Device Description
     The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

6. Identification of Predicate Device(s)

Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited

K180849 Vinyl Examination Glove (Clear, Non-Colored) HUIFU TRADING CO., LTD.

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ITEM	Proposed Device (K182043)	Predicate Device (K163168)	Predicate Device (K180849)	Remark
Product Code	LYZ	LYZ	LYZ	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	I	SAME
Intended Use	The Single-use medical poly
(vinyl chloride) 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.	The Vinyl Examination Glove
(White, Blue, or Yellow) 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 Patient
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
Powdered or
Powered free	Powdered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	ambidextrous	SAME
Surface Feature	Smooth	Smooth	Smooth	SAME
Labeling
Information	Single-use indication, powder
free, device color, device
name, glove size and quantity,
Vinyl Examination Gloves,
Non-Sterile	Single-use indication, powder
free, device color, device name,
glove size and quantity, Vinyl
Examination Gloves, Non-Sterile	Single-use indication, powder
free, device color, device
name, glove size and quantity,
Vinyl Examination Gloves,
Non-Sterile	SAME

7. Technological Comparison

Table 1 General Comparison

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	Designation	Size					Tolerance
		XS	S	M	L	XL
Proposed Device (K182043)	Length, mm	240	240	240	240	240	min
	Width, mm	80	85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.07					min
	Palm	0.08					min
Predicate Device (K163168)	Designation	XS	S	M	L	XL	Tolerance
	Length, mm	230	230	235	245	245	min
	Width, mm	80	85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Predicate Device (K180849)	Designation		S	M	L	XL	Tolerance
	Length, mm		230	235	245	245	min
	Width, mm		85	95	105	115	$\pm 5$
	Thickness, mm:
	Finger	0.05					min
	Palm	0.08					min
Remark	Analysis 1

Table 2 Device Dimensions Comparison

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| ITEM | Proposed Device
(K182043) | Predicate Device
(K163168) | Predicate Device
(K180849) | Remark | |
|------------------------|----------------------------------------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------|
| Colorant | Clear, Non-Colored | White, Blue,
Yellow | Clear,
Non-Colored | Analysis 2 | |
| Physical
Properties | Before
Aging | Tensile
Strength
15 MPa, min | 15 MPa, min | 15 MPa, min | Analysis 3 |
| | Ultimate
Elongation | 350 % min | 380 % min | 380 % min | |
| | After
Aging | Tensile
Strength
15 MPa, min | 15 MPa, min | 15 MPa, min | |
| | Ultimate
Elongation | 350 % min | 380 % min | 380 % min | |
| | Comply with ASTM D5250 | | Comply with
ASTM D5250 | Comply with
ASTM D5250 | SAME |
| Freedom from Holes | Be free from holes
when tested in
accordance with
ASTM D5151
AQL=1.5 | | Be free from holes
when tested in
accordance with
ASTM D5151
AQL=1.5 | Be free from holes
when tested in
accordance with
ASTM D5151
AQL=1.5 | SAME |
| Powder Content | 0.33 mg | | Meet the
requirements of
ASTM 5250 | Meet the
requirements of
ASTM 5250 | SAME |

Table 3 Performance Comparison

Table 4 Safety Comparison

| ITEM | Proposed Device (K182043) | Predicate Device
(K163168) | Predicate Device
(K180849) | Remark | |
|--------------------|---------------------------|--------------------------------------------------------------------------------------|-------------------------------|-----------------------------|------|
| Material | Vinyl | Vinyl | Vinyl | SAME | |
| Biocompatibility | Irritation | Under the conditions of the
study, not an irritant | Comply with ISO
10993-10 | Comply with ISO
10993-10 | SAME |
| | Sensitization | Under conditions of the study,
not a sensitizer. | Comply with ISO
10993-10 | Comply with ISO
10993-10 | SAME |
| | Cytotoxicity | Under conditions of the study,
did not show potential toxicity
to L-929 cells. | / | Comply with ISO
10993-5 | SAME |
| Label and Labeling | | Meet FDA's Requirements | Meet FDA's
Requirements | Meet FDA's
Requirements | SAME |

Analysis 1:

The proposed device has different Length to the predicate device, but all proposed devices are conducted the test according ASTM 5250, the test results shown that the Length of proposed device meet the

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requirements of standard.

Analysis 2:

The proposed device has different color to the predicate device, but all proposed devices are conducted the test according ISO 10993-5 and ISO 10993-10 for Irritation and Cytotoxicity, and other non-clinical bench test.

The test results shown that the performance of proposed device meet the requirements of standard and no potential biocompatibility issues.

So, the different color would not effects the safety and effectiveness of proposed device.

Analysis 3:

The proposed device has different Ultimate Elongation to the predicate device, but all proposed devices are conducted the test according ASTM 5250, the test results shown that the Ultimate Elongation of proposed device meet the requirements of standard.

8. Non-Clinical Test Conclusion

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

• ISO 10993-5:2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro A Cytotoxicity

• ASTM D6124-06 (Reaffirmation 2017), Standard Test Method for Residual Powder on Medical Gloves

• ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical > Gloves.

• ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.

• ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.

• Clinical Test Conclusion 9.

Clinical testing is not needed for this device.

• 10. Conclusion
      The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.