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 or ML capabilities.

Therapeutic

No.
The device is described as a "non sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner," which indicates it is a barrier device for protection, not a therapeutic device designed to treat or alleviate a disease or condition.

Diagnostic

No

The device description indicates that the gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This function is for protection and hygiene, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the summary describes physical properties and testing, 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 clearly states the gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function for protection, not a diagnostic test performed on samples taken from the body.
Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D 5250-06). This is consistent with a medical device for protection, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
Performance Studies: The performance studies focus on physical properties, freedom from pinholes, residual powder, and biocompatibility – all relevant to a protective barrier device, not an IVD.

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

Powder Free White Vinyl Patient Examination Gloves is a non sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Product codes

LYZ

Device Description

Powder-Free White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
-- Physical and performance characteristics such as design, materials and physical properties:
PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical tests were conducted to demonstrate substantial equivalence:

Powder-Free White Vinyl Patient Examination Gloves meet requirements per ASTM D5250-06(Reaffirmation 2011)
per ASTM D6124-06(Reaffirmation 2011)
per 21 CFR 800.20
and ISO 10993-10 Third Edition 2010-08-01.

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Key results: It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and the Powder-Free White Vinyl Patient Examination Gloves is as safe, as effective, and performs as well as the predicate device Powder-Free Vinyl Patient Examination Gloves, White Color, Tangshan Hengda Plastic Products Co.,Ltd. K102558.

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

Length: ≥230mm min.
Width: Small 83-86 mm, Medium 93-96 mm, Large 104-106mm, X large 113-116 mm
Thickness: Finger 0.05mm min., Palm 0.08mm min.
Elongation: ≥300% (Before aging/after aging)
Tensile Strength: ≥ 11MPa (Before aging/after aging)
Freedom from Pinholes: Inspection Level I, AQL 2.5
Residual Powder: below 2mg

Predicate Device(s)

K102558

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 4, 2014

Zibo Goldenline Plastic Products Company, Ltd. C/O Chu Xiaoan Official Correspondent Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA

Re: K141613

Trade/Device Name: Powder free White Vinyl Patient examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: November 14, 2014 Received: November 17, 2014

Dear Mr. Xiaoan:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141613

Device Name

Powder Free White Vinyl Patient Examination Gloves

Indications for Use (Describe)

Powder Free White Vinyl Patient Examination Gloves is a non sterile disposable device intended for medical purposes that is worn on the examiner's hand 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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EF

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Section C

510(k) Summary

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is:

Premarket Notification [510(k)] Summary

[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

Submitter's name :	Zibo Goldenline Plastic Products Company Limited
Submitter's address :	No 22, Century Road, Zibo, Shandong, 255000, China
Phone number :	(86)533-3819145
Fax number :	(86)533-3819145
Name of contact person:	Victor Zhao
Date the summary was prepared:	2014-11-05

[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Device Name:	Powder-Free White Vinyl Patient Examination Gloves
Proprietary/Trade name:	"Powder-Free White Vinyl Patient Examination Gloves"
Common Name:	Patient examination glove
Classification Name:	Patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital (80)
Product Code:	LYZ

[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .

Class I Powder-Free White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).

Predicate device: Powder-Free Vinyl Patient Examination Gloves, White Color, Tangshan Hengda Plastic Products Co., Ltd. K102558.

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[(a)(4)] A description of the device

Device Description: Powder-Free White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

-- How the device functions:

PVC films form a barrier to body fluids and bloodborne Pathogens

-- Scientific concepts that form the basis for the device The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

[(a)(5)] The summary describes the intended use of the device

Device Intended Use: Powder-Free White Vinyl Patient Examination Gloves 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.

Features & Description	Predicate Device	Subject Device	Result of Comparison
Company	Tangshan Hengda Plastic Products Co.,Ltd.	Zibo Goldenline Plastic Products Company Limited	--
510(K) Number	K102558	K141613
Product name	Powder-Free Vinyl Patient Examination Gloves, White Color	Powder-Free White Vinyl Patient Examination Gloves	Same
Product Code	LYZ	LYZ	Same
Size	Small/ Medium/ Large/X large	Small/ Medium/ Large/X large	Substantially equivalent
Intend for use	Powder-Free Vinyl Patient Examination Gloves, White Color 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.	Powder-Free White Vinyl Patient Examination Gloves 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.	Substantially equivalent
Device Description and Specifications	Meets ASTM D5250-06 (Reapproved 2011)	Meets ASTM D5250 -06 (Reapproved 2011)	Substantially equivalent
Dimensions -- Length	Meets ASTM D5250-06 (Reapproved 2011) $≥230mm min.$	Meets ASTM D5250-06 (Reapproved 2011) $230mm min for all sizes$	Substantially equivalent
Dimensions -- Width	Meets ASTM D5250-06 (Reapproved 2011) $Small 80-90 mm Medium 90-100mm Large 100-110mm X large 110-120 mm$	Meets ASTM D5250-06 (Reapproved 2011) $Small 83-86 mm Medium 93-96 mm Large 104-106mm X large 113-116 mm$	Substantially equivalent
Dimensions -- Thickness	Meets ASTM D5250-06 (Reapproved 2011)	Meets ASTM D5250-06 (Reapproved 2011)	Substantially equivalent
	Finger 0.05mm min.
Palm 0.08mm min.	Finger 0.05mm min.
Palm 0.08mm min.
Physical Properties	Meets ASTM D5250-06
(Reapproved 2011)	Meets ASTM D5250-06
(Reapproved 2011)	Substantially
equivalent
	Before aging/after aging
Elongation ≥300%
Tensile Strength≥11MPa	Before aging/after aging
Elongation ≥300%
Tensile Strength≥ 11MPa
Freedom from
Pinholes	Meets
• 21 CFR 800.20
• ASTM D5250-06
(Reapproved 2011)
• ASTM D 5151-06
(Reapproved 2011)	Meets ASTM
D5151-06 (Reapproved 2011)

SKIN IRRITATION
DERMAL and
SENSITIZATION STUDIES
Meets ISO 10993-10 Third
Edition 2010-08-01 | Substantially
equivalent |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -Powder Free
-Devices color: White
-Patient Examination Glove
-Non sterile
-Single Use Only

Manufactured For: | -Powder Free
-Devices color: White
-Patient Examination Glove
-Non sterile
-Single Use Only
Manufactured For: | Substantially
equivalent |

The Powder-Free White Vinyl Patient Examination Gloves non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

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[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Powder-Free White Vinyl Patient Examination Gloves meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01.

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

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[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and the Powder-Free White Vinyl Patient Examination Gloves is as safe, as effective, and performs as well as the predicate device Powder-Free Vinyl Patient Examination Gloves, White Color, Tangshan Hengda Plastic Products Co.,Ltd. K102558.