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, ML, or any related technologies.

Therapeutic

No.
The device is a non-sterile disposable glove intended to prevent contamination, not to treat or alleviate a disease or condition.

Diagnostic

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

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the description focuses on material standards and performance studies related to physical properties, not software functionality.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this device is a "Powder Free Vinyl Patient Examination Glove." Its intended use is to be worn on the hand or finger to prevent contamination between the patient and the examiner.
Lack of Diagnostic Function: The device does not perform any tests on biological samples, analyze any bodily fluids or tissues, or provide any diagnostic information about a patient's health condition.

The information provided describes a medical device used for barrier protection during examinations, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

"Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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 Vinyl Patient Examination Gloves, Clear (non-colored) 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 Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011)."
"PVC films form a barrier to body fluids and bloodborne Pathogens"
"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."
"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 (for 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical performance testing was conducted based on the following standards:

ASTM D5250-06 (Reaffirmation 2011) for Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)
ASTM D6124-06 (Reaffirmation 2011) for Residual Powder
21 CFR 800.20 and ASTM D5151-06 (Reapproved 2011) for Freedom from Pinholes
ISO 10993-10 Third Edition 2010-08-01 for Biocompatibility (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES)

Key Results:

Meets ASTM D5250-06 (Reapproved 2011) for Device Description and Specifications, Dimensions (Length, Width, Thickness), and Physical Properties (Elongation ≥300%, Tensile Strength ≥11MPa before/after aging).
Meets ASTM D5151-06 (Reapproved 2011) with Holes Inspection Level I, AQL 2.5 for Freedom from Pinholes.
Results generated values below 2mg of residual powder, meeting ASTM D6124-06 (Reaffirmation 2011).
The test article was a non-irritant or non-sensitizer based on SKIN IRRITATION DERMAL and SENSITIZATION STUDIES, meeting ISO 10993-10 Third Edition 2010-08-01.

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

Physical Properties: Elongation ≥300% (Before aging/after aging), Tensile Strength ≥11MPa (Before aging/after aging)
Freedom from Pinholes: AQL 2.5
Residual Powder: below 2mg

Predicate Device(s)

K120968

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

0

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 :	Feiyue Glove Co., Ltd.
Submitter's address :	Xixiangge Village, Sigezhuang Town, Luannan County,
Hebei Province, 063502, China
Phone number :	(86) 315- 4169201
Fax number
"	(86) 315-4430333
Name of contact person:	Zhang Liang
Date the summary was prepared:	2014-05-03

[(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 Vinyl Patient Examination Gloves, Clear
(Non-colored) |
|-------------------------|--------------------------------------------------------------------------------|
| Proprietary/Trade name: | "Feiyue Powder Free Vinyl Patient Examination Gloves, Clear
(non-colored)." |
| 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 Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).

Predicate device : Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd.. K120968 .

Section C (rev.01)

1

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

Device Description : Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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 Vinyl Patient Examination Gloves, Clear (Non-colored) 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 Vinyl Patient Examination Gloves, Clear (Non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Features

& Description	Predicate Device	Subject Device	Result of Comparison
Company	Tangshan Zhonghong Pulin
Plastic Co.,Ltd.	Feiyue Glove Co., Ltd.	--
510(K) Number	K120968	K140242
Product name	Powder Free Vinyl Patient
Examination Gloves, Clear
(Non-colored)	Powder Free Vinyl Patient
Examination Gloves, Clear
(Non-colored)	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,
Clear(Non-colored)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 Vinyl Patient
Examination Gloves, Clear
(Non-colored) 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)	Meets ASTM D5250-06
(Reapproved 2011)	Substantially
equivalent
	≥230mm min.	230mm min for all sizes
Dimensions
-- Width	Meets ASTM D5250-06
(Reapproved 2011)	Meets ASTM D5250-06
(Reapproved 2011)	Substantially
equivalent
	Small 80-90 mmr
Medium 90-100mm
Large 100-110mm
X large 110-120 mm	Small 85-88 mm
Medium 94-97 mm
Large 103-106 mm
X large 113-115 mm
Dimensions	Meets ASTM D5250-06	Meets ASTM D5250-06
-- Thickness	(Reapproved 2011)	(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)	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≥ 11 MPa
Freedom from
Pinholes	Meets
21 CFR 800.20
ASTM D5250-06
(Reapproved 2011)	Meets ASTM
D5151-06 (Reapproved 2011)	Substantially
equivalent
	• ASTM D 5151-06
(Reapproved 2011)	Holes
Inspection Level I
AQL2.5
Residual Powder	Meets ASTM
D6124-06 (Reaffirmation

                                                                                                                                                                                            | ASTM D6124-06

Manufactured For:
Lot | -Powder Free
-devices color:
Clear(Non-colored)
-Patient Examination Glove
-Non sterile
-Single Use Only
Manufactured For:
Lot | Substantially
equivalent |
| | | | |

2

[{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 Vinyl Patient Examination Gloves, Clear (Non-colored)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.

3

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. ((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 Vinyl Patient Examination Gloves, Clear (Non-colored) is as safe, as effective, and performs as well as the predicate device, Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd. K120968 .

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

June 12, 2014

Feivue Glove Co., Ltd % Chu Xiaoan Official Correspondent Room 1606 Bldg.1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA

K140242 Re:

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Noncolored)

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 3, 2014 Received: May 15, 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 Eederal Register.

5

Page 2 - Chu Xiaoan

: :

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 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 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

:

··

Sincerely yours, Teiashri P 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

Enclosure

6

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140242

Device Name

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Indications for Use (Describe)

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

A STERE OF CONSTITUTION FORIFORIFOR FOR FOR FOR THE CONTRACT CONTRACT CONTRACT ala - 1 - 10 -Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sreekanth Gutala Digitally signed by Sreekanth Gutala -S
-S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA,
ou=People, 0.9.2342.19200300.100.1.1=2000540490,
cn=Sreekanth Gutala -S
Date: 2014.08.11 16:13:10 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valld OMB number."

FORM FDA 3881 (1/14)