Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the description contains no mention of AI, ML, or any related technologies.

Therapeutic

No
The device, "Powder-Free Vinyl Patient Examination Gloves," is described as preventing contamination, which is a protective measure rather than a treatment for a disease or condition.

Diagnostic

No
Explanation: 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 (gloves) and the description focuses on material standards and performance testing related to those physical properties, with no mention of software components.

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, not a diagnostic function performed in vitro (outside the body).
Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D 5250-06). There is no mention of reagents, assays, or any components used to analyze biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information about a patient's health status

The device is a medical device, specifically a patient examination glove, but its function is protective and preventative, not diagnostic.

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 non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and exeminer.

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

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).
-- 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 leaching process removes traces of chemical accelerants that may be chemically irritating. 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 (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 tests were performed.
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: 2002/Amd. 1:2006(E).
The test article was a non-irritant or non-sensitizer based on SKIN IRRITATION DERMAL and SENSITIZATION STUDIES that met ISO 10993-10:2002/Amd.1:2006.
Results for residual powder were below 2mg.
The device meets the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL.

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

Not Found

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.

K120968

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

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: ______________ K130732 _______ ." (applicant leave blank)

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 :	Aide Plastic Co., Ltd.
Submitter's address :	No.88, Huai An West Rd. Shijiazhuang, 050000, China
Phone number :	(86) 311-67699828
Fax number :	(86) 311-67699906
Name of contact person:	Mr. Zhang Hai
Date the summary was prepared:	Dec.15.2013

[(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:	Adie
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

J(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 .

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[(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 leaching process removes traces of chemical accelerants that may be chemically irritating. 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. | Aide Plastic Co., Ltd. | -- |
| 510(K) Number | K120968 | K130732 | |
| 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)
≥230mm min. | 230mm min for all sizes | Substantially
equivalent |
| Dimensions
-- Width | Meets ASTM D5250-06 (Reapproved
2011)

Small 80-90 mmr
Medium 90-100mm
Large 100-110mm
X large 110-120 mm | Meets ASTM D5250-06 (Reapproved
2011)

Small 80-85 mm
Medium 95-97 mm
Large 102-108 mm
X large 114-118 mm | Substantially
equivalent |
| Dimensions
-- Thickness | Meets ASTM D5250-06 (Reapproved
2011)

Before aging/after aging
Elongation ≥300%
Tensile Strength≥14MPa | Before aging/after aging

Elongation ≥300%
Tensile Strength≥ 14MPa | Substantially
equivalent |
| Freedom from Pinholes | Meets
• 21 CFR 800.20
• ASTM D5250-06
(Reapproved 2011)
• ASTM D 5151-06
(Reapproved 2011) | Meets ASTM D5151-06
(Reaffirmation 2011)

SKIN IRRITATION DERMAL and
SENSITIZATION STUDIES Meets
ISO 10993-10:2002/Amd.1:2006 | Substantially
equivalent |
| Labeling for the legally
marketed device to
which substantial
equivalence is claimed. | -Powder Free
-Patient Examination Glove
-glove color, clear (non-colored)

non sterile
-Single Use Only
-Manufactured For:
Lot | -Powder Free
-Patient Examination Glove
-glove color, clear (non-colored)
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: 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.

Section C(rev.02)

3

[(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 .

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 16, 2014

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

Re: K130732

Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 16, 2013 Received: December 19, 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.

5

Page 2 - Mr. 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 tollfree 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/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.

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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 130732

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 exeminer.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

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

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FORM FDA 3881 (9/13)

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