Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
Explanation: The device, Powder Free Yellow Synthetic Vinyl Patient Examination Gloves, is intended to prevent contamination and is not described as treating or alleviating a disease or condition.

Diagnostic

No

Explanation: The device is a patient examination glove used to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is described as physical gloves, not software. The description and performance studies focus on material properties and physical standards.

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 is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, 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).
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.

IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device is a barrier intended for protection.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Powder Free Yellow Synthetic 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.

Product codes (comma separated list FDA assigned to the subject device)

LYZ

Device Description

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

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

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)

Non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device. These tests confirmed that the Powder Free Yellow Synthetic 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: 2002/Amd. 1:2006(E). The device passed tests for freedom from pinholes (AQL 2.5), residual powder (below 2mg), and biocompatibility studies (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES, meeting ISO 10993-10). Clinical data was not needed. The conclusion was that the device is as safe, as effective, and performs as well as the predicate device.

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

Elongation ≥300%
Tensile Strength≥ 14MPa
Freedom from Pinholes: AQL2.5
Residual Powder: below 2mg

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD K110945

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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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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 :	Shijiazhuang Winful Plastic Co., Ltd.
Submitter's address :	No.6 Cangshi Road, Jinzhou City, Hebe i, 052260, China
Phone number :	(86) 31184320503
Fax number :	(86) 31184311294
Name of contact person:	Yin Mingfei
Date the summary was prepared:	January 27, 2014

[(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 Yellow Synthetic Vinyl Patient Examination Gloves
Proprietary/Trade name:	Powder Free Yellow Synthetic 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 Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).

Predicate device : POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD K110945

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|(a)(4)| A description of the device

Device Description : Powder Free Yellow Synthetic 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. Its 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 Yellow Synthetic 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.

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

| Features &
Description | Predicate Device | Subject Device | Result of
Comparison |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 510(k) Number | K110945 | K131341 | -- |
| Company | ZHAOYANG PLASTIC CO.,
LTD | Shijiazhuang Winful Plastic
Co., Ltd. | -- |
| Product name | POWDER-FREE YELLOW
SYNTHETICVINYL PATIENT
EXAMINATION
GLOVES | Powder Free Yellow
Synthetic Vinyl Patient
Examination Gloves | -- |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/
Large/X large | Small/ Medium/
Large/X large | Small/ Medium/
Large/X large |
| Intend for use | POWDER-FREE YELLOW
SYNTHETIC 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. | Powder Free Yellow
Synthetic 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. | 230mm min for all sizes | Substantially
equivalent |
| Dimensions
-- Width | Meets ASTM D5250-06
(Reapproved 2011) | Small 80-85 mm
Medium 95-97 mm
Large 102-108mm | Substantially
equivalent |
| | Small 80-90 mm | | |

2

		X large 114-118 mm
	Medium 90-100mm
Large 100-110mm
X large 110-120 mm
Dimensions
-- Thickness	Meets ASTM D5250-06
(Reapproved 2011)
	Finger 0.05mm min.
Palm 0.08mm min.	Finger 0.05mm min.
Palm 0.08mm min.
Physical Properties	Meets ASTM D5250-06
(Reapproved 2011)	Before aging/after aging	Substantially
equivalent
	Before aging/after aging
Elongation ≥300%
Tensile Strength≥14MPa	Elongation ≥300%
Tensile Strength≥ 14MPa
Freedom from
Pinholes	Meets
21 CFR 800.20
ASTM D5250-06
(Reapproved 2011)
ASTM D 5151-06-
(Reapproved 2011)	Meets ASTM
D5151
Holes
Inspection Level I
AQL2.5	Substantially
equivalent
Residual Powder	Meets ASTM
D 6124-06
(Reapproved 2011)	D 6124-06
(Reapproved 2011)
Results generated values
below 2mg of residual powder	Substantially
equivalent
Compare all
materials used to
fabricate the
devices	PVC	PVC	Substantially
equivalent
Dusting or
Donning
Powder:	PU	PU	Substantially
equivalent
Dusting or
Donning
Powder: name	PU	Surface Coating Agent	Substantially
equivalent
Compare
performance data
supporting
substantial
equivalence	Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reapproved 2011)	Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reapproved 2011)	Substantially
equivalent
Single Patient
Use	Single Patient Use	Single Patient Use	Substantially
equivalent
Biocompatibility	Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed.	SKIN IRRITATION DERMAL
and SENSITIZATION STUDIES
Meets ISO 10993-10	-Powder-free
-Patient Examination Glove

Yellow color
-non sterile
-Single Use Only
Manufactured For:
Lot | The test article was a
non-irritant or
non-sensitizer.
SKIN IRRITATION
DERMAL and | DERMAL and
SENSITIZATION
STUDIES Meets ISO
10993-10

-Powder-free
-Patient Examination Glove

Yellow color
-non sterile
-Single Use Only
Manufactured For:
Lot | Substantially
equivalent | Substantially
equivalent |

(b)(1)) A brief discussion of the non-clinical submitted, reference, or relied on in the premarket
notification submission for a determination of substantial equivalence

Section C (rev.03)

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Powder Free Yellow Synthetic 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: 2002/Amd. 1:2006(E).

((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.

[(b)(3)] The conclusions drawn from the non-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 Yellow Synthetic Vinyl Patient Examination Gloves is as safe, as effective, and performs as well as the predicate device, POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EX AMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD K110945

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

February 6, 2014

Shijiazhuang Winful Plastic Company, Limited C/O Mr. Chu Xiaoan Room 1606 Bldg 1 Jianxiang Yuan #209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA

Re: K131341

Trade/Device Name: Powder Free Yellow Synthetic Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 19, 2013 Received: December 30, 2013

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,

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Erin I. Keith, M.S. 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) K 131341

Device Name

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves

Indications for Use (Describe)

Powder Free Yellow Synthetic Viryl 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CHE CONNECT CALL CORTED LOSE ONLY PART ALL ALL AND CALL AND CALL AND CALL COLLECT COLLECT COLLECT C Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

PSC Publishing Services (101) 44)-6740 EF

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