Powder-free PVC Vinyl Exam Gloves

• K Number: K142703
• Device Name: Powder-free PVC Vinyl Exam Gloves
• Manufacturer: Hebei Grandeast Plastic Products Co., Ltd.
• Date Cleared: 2015-01-15 ( 115 days)
• Product Code: LYZ
• Regulation Number: 880.6250

Intended Use

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Predicate Devices

K130733

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and safety standards of medical gloves, with no mention of AI or ML technologies.

Therapeutic

No.
The device, Powder-free PVC Vinyl Exam Gloves, is intended to prevent contamination and is not designed for therapeutic purposes or to treat a condition.

Diagnostic

No

The device is described as powder-free PVC vinyl exam gloves, intended to prevent contamination between patient and examiner. There is no mention of it being used to diagnose conditions or process diagnostic information.

SaMD (Software as a Medical Device)

No

The device is described as physical gloves made of PVC Vinyl, not software.

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 hands or fingers 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 reinforces the barrier function and mentions they are "disposable medical gloves intended to be worn on the examiner's hands or fingers."
• Lack of Diagnostic Activity: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
• Testing Performed: The testing described focuses on the physical properties of the gloves (tensile strength, elongation, freedom from holes, powder residue) and biocompatibility (sensitization, irritation). These are tests related to the glove's function as a barrier and its safety for contact, not diagnostic performance.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

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

LYZ

Device Description

The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or fingers

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)

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM D5250-06 (Reapproved 2011), Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
ASTM D5151-06 (Reapproved 2011), Standard Test Method For Detection Of Holes In Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method For Residual Powder On Medical Gloves.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

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.

K130733

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

January 15, 2015

Hebei Grandeast Plastic Products Co., Ltd. C/O Ms. Diana Hong General Manager Mid- Link Consulting Co., Ltd. PO Box 120-119, Shanghai CHINA

Re: K142703

Trade/Device Name: Powder-Free PVC 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 15, 2014 Received: December 19, 2014

Dear Ms. Diana Hong:

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 [phone] or [phone] 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 [phone] or [phone] 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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142703

Device Name

Powder-free PVC Vinyl Exam Gloves

Indications for Use (Describe)

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Tab #2 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

• 1. Date of Submission: 01/06/2015
• 2. Sponsor Identification

Hebei Grandeast Plastic Products Co., Ltd. Industrial Park, Julu County, Hebei Province, China

Establishment Registration Number: Not yet registered

Contact Person: Wei Liu Position: Sale Manager Tel: [phone] Fax: [phone] Email: [e-mail]

• 3. Submission Correspondent
     Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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• 4. Proposed Device Identification
     Proposed Device Name: Powder-free PVC Vinyl Exam Gloves Proposed Device Common Name: Powder-free Exam Gloves

Regulatory Information: Classification Name: Vinyl Patient Examination Glove: Classification: I; Product Code: LYZ; Regulation Number: 21 CFR 880.6250; Review Panel: General Hospital;

Intended Use Statement:

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

• 5. Predicate Device Identification
     510(k) Number: K130733

Product Name: Benteng Power Free Vinyl Patient Examination Gloves, Clear (non-colored) Manufacturer: Benteng Plastic Co., Ltd.

• Device Description 6.
  The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

• 7. Non-Clinical Test Conclusion
     Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D5250-06 (Reapproved 2011), Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

ASTM D5151-06 (Reapproved 2011), Standard Test Method For Detection Of Holes In Medical Gloves. ASTM D6124-06 (Reaffirmation 2011), Standard Test Method For Residual Powder On Medical Gloves.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin

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sensitization.

• 8. Substantially Equivalent (SE) Conclusion
     The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device(s)
Product Code	LYZ	LYZ
Regulation No.	21 CFR 880.6250	21 CFR 880.6250
Class	I	I
Intended Use	The Powder-free PVC Vinyl Exam
Gloves are disposable devices intended
for medical purposes that are worn on
the examiner's hands or fingers to
prevent contamination between patient
and examiner.	Powder Free Vinyl Patient
Examination Gloves, Clear
(non-colored) is 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.
Powdered or
Powered free	Powered free	Powered free
Size	S, M, L and XL	S, M, L and XL
Dimensions
Length	Comply with ASTM D5250-06
(Reapproved 2011)

230 mm | Comply with ASTM D5250-06
(Reapproved 2011)
230 mm |
| Dimensions
Width | Comply with ASTM D5250-06
(Reapproved 2011)
S 85±5mm
M 95±5mm
L 105±5mm
XL 115±5mm | Comply with ASTM D5250-06
(Reapproved 2011)
S 85±5mm
M 95±5mm
L 105±5mm
XL 115±5mm |
| Dimensions
Thickness | Comply with ASTM D5250-06
(Reapproved 2011)
Palm 0.10±0.02mm
Finger-tip 0.10±0.02mm | Comply with ASTM D5250-06
(Reapproved 2011)
Palm > 0.08mm
Finger-tip > 0.05mm |
| Colorant | No colorant used | No colorant used |
| Single Use | Yes | Yes |
| Physical
Properties | Before aging / after aging:
Tensile Strength ≥ 11Mpa. | Before aging / after aging:
Tensile Strength ≥ 11Mpa. |
| | | |
| | Ultimate Elongation $\ge$ 300%
Comply with ASTM D5250-06
(Reapproved 2011) | Ultimate Elongation $\ge$ 300%
Comply with ASTM D5250-06
(Reapproved 2011) |
| Freedom from
Holes | Comply with ASTM D5250-06
(Reapproved 2011) and ASTM
D5151-06 (Reapproved 2011) | Comply with ASTM D5250-06
(Reapproved 2011) and ASTM
D5151-06 (Reapproved 2011) |
| Residue Powder | 0.6 +/- 0.1 mg per glove
Comply with ASTM D5250-06
(Reapproved 2011) | $